Piedmont Triad Region

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NORTH CAROLINA BIOPHARMA MANUFACTURING LABOR MARKET ANALYSIS — Piedmont Triad Region

Alamance County Chamber of Commerce | Duke Energy | Gateway University Research Park Greensboro Economic Development Alliance | High Point Economic Development Corporation | North Carolina Biotechnology Center | Piedmont Triad Partnership | Piedmont Triad Research Park | Winston-Salem Business Alleghany Gates Ashe Surry Person Northampton CamdenCurrituck Stokes Rockingham Caswell Vance Warren Hertford Wilkes Pasquotank Watauga Granville Halifax Perquimans Yadkin Piedmont Forsyth Orange Franklin Avery Guilford Mitchell Triad Bertie Chowan Caldwell Alexander Alamance Durham Nash Edgecombe Davie Madison Yancey Tyrrell Wake Martin Washington Dare Burke Iredell Davidson Wilson Randolph Chatham Buncombe McDowell Catawba Rowan Haywood Pitt Beaufort Lincoln Johnston Hyde Swain Lee Greene Rutherford Cabarrus Graham Henderson Stanly Harnett Wayne Lenoir Jackson Polk Gaston Moore Cleveland Montgomery Craven Transylvania Mecklenburg Cherokee Macon Pamlico Clay Cumberland Richmond Sampson Union Anson Hoke Jones Duplin Onslow Scotland Carteret

Robeson Bladen Piedmont Triad Laborshed Pender

Columbus NewHanover Twelve North Carolina counties: Brunswick Alamance Caswell Davidson Davie Forsyth Guilford Orange Randolph Rockingham Stokes Surry Yadkin

Thank you to the sponsors of the Piedmont Triad Region Biopharma Manufacturing Labor Market Analysis:

Alamance County Chamber of Greensboro Economic Piedmont Triad Partnership Commerce Development Alliance • www.piedmonttriadnc.com • www.ChooseAlamanceNC.com • www.greensboroeda.com • [email protected] • andreafleming@alamancechamber. • [email protected] com Piedmont Triad Research Park High Point Economic • www.ptrp.com Duke Energy Development Corporation • [email protected] • www.duke-energy.com/ • www.highpointedc.com economic-development/ • [email protected] Winston-Salem Business Inc. economic-development.asp • www.wsbusinessinc.com • [email protected] North Carolina Biotechnology • [email protected] Center Gateway University Research Park • www.ncbiotech.org • [email protected] • www.gatewayurp.com • [email protected]

TM TABLE OF CONTENTS

1. EXECUTIVE SUMMARY ...... 2

2. INTRODUCTION ...... 4 2.1 Background ...... 4 2.2 Organization ...... 4 2.3 Methodology ...... 4 2.4 Project and Labor Requirements ...... 5 2.5 Geographic Scope ...... 5 2.6 Data Gathering ...... 7 2.7 Data Limitations ...... 7

3. THE SUPPLY OF EXISTING BIOPHARMA MANUFACTURING LABOR ...... 8 3.1 Biopharma Industry Profile ...... 8 3.2 Biopharma Manufacturing Occupations ...... 8 3.3 Existing Biomanufacturing Skill Base ...... 10 3.4 Manufacturing/Production Labor ...... 12 3.5 Quality Assurance/Quality Control Labor ...... 12 3.6 Process Development Labor ...... 13 3.7 Plant Operations Labor ...... 13

4. THE SUPPLY OF EMERGING BIOPHARMA MANUFACTURING TALENT ...... 15 4.1 Emerging Biopharma Manufacturing Skill Base ...... 15 4.2 BioWork Enrollment and Course Completions ...... 15 4.3 Biopharma Manufacturing Curricula ...... 15 4.4 Community College Enrollment ...... 16 4.5 Undergraduate Degrees ...... 17 4.6 Graduate and Ph.D Degrees ...... 19

5. CONCLUSIONS ...... 20

REFERENCES ...... 21 PI e DMONT TRIAD BIOPHARMA MANUFACTURING LABOR MARKET ANALYSIS

instructors at community colleges and universities and 1. EXECUTIVE SUMMARY economic developers. We also accessed federal and state occupational and academic data bases, among other secondary information sources. Biggins Lacy Shapiro & Co, (BLS & Co), a New Jersey- based site selection and economic development consultancy, 4. Inferring from these data the depth and breadth of was engaged by the North Carolina Biotechnology Cen- the regional labor market and its ability to sustain our ter and its economic development partners in and around project. Greensboro, High Point and Winston-Salem, NC. (“The Our findings address each of the plant’s most important Triad”) to gauge the capability of the region’s labor force functions: 2 to sustain significant biomanufacturing plant investments. Upon completing this assignment it is our conclusion that the Triad regional labor market is capable of supporting an Manufacturing/Production initial biopharmaceutical manufacturing plant if scale-up could be managed at pace that would enable the recruiting, Among the medical device manufacturers, diagnostic training and development staff to understand and adjust test kit suppliers and clinical diagnostic laboratories that to local market conditions and to assimilate new employ- hire primarily high school graduates and characterize so ees. Ultimately the region should exhibit the capacity to much of the Triad life sciences cluster, employers reported absorb several more of these operations without seriously little difficulty attracting applicants for most production straining local resources. positions. However, some of the region’s relatively small contract manufacturers and pilot plant operators have Our analysis adopts a site selector’s perspective and was expressed concerns about the area’s ability to provide large designed around the types of information that clients typi- numbers of more highly-skilled operators and technicians cally try to understand before making an important loca- over a relatively short period of time. tion decision. Our methodology borrows from site selection engagements and labor market assessments performed on Based on our analysis of occupational employment data behalf of corporate clients and refined over years of prac- for the region, BLS & Co projects approximately 4,500 tice. This approach included: potential applicants for the 140 manufacturing/production positions requiring previous experience that are to be 1. Creating a “proxy” project and associated labor included in the proxy plant. As these jobs would be filled requirements. The basis for this analysis was a fully at the rate of 70 per year the data do indicate that the integrated, GMP compliant, biologics manufacturing potential labor supply would certainly exceed the target plant producing an existing, approved, cell-based drug. 15:1 hiring ratio in any given year. Nonetheless some of The plant will ramp-up staffing over a 2-year period. our employer interviews suggest that skill levels might be Our hiring standard is based on 15 potential appli- an issue for a biomanufacturer. cants for each available position (15:1 hiring ratio). In conjunction with the annual output from BioWork 2. Defining the geographic boundaries of the labor mar- and the bioprocessing certificate program at Alamance ket (the “laborshed”). This constituted a 12-county Community College, the region’s community colleges are region in central North Carolina comprising an expected to produce 77 prospective production employees approximately 45-minute commuting distance around annually to satisfy our project’s appetite for 30 inexperi- four principal employment nodes in the Triad (Greens- enced new hires per year. boro, High Point, Winston-Salem and Burlington). 3. Quantifying and assessing the availability of experi- Quality Assurance/Quality Control enced manufacturing talent in the laborshed and new workforce entrants who will replenish this pool. To do While our data indicate that the Triad’s supply of experi- so we identified the most relevant occupations in key enced QA/QC workers should be adequate to staff a new, functional areas of a biologics plant: 1] Manufactur- large biomanufacturing operation, some of the employers ing/Production; 2] Quality Assurance/Quality Con- with whom we spoke were apprehensive about the avail- trol; 3] Process Development; and 4] Plant Operations ability of analytical chemists and similar disciplines with and Support. We also attempted to align these func- experience in a GMP setting, attributes that are particu- tions with the various degree programs at North Car- larly important to a biomanufacturer. olina’s community colleges and universities. Data was BLS & Co projects a potential applicant pool of approxi- gathered via interviews with human resources offi- mately 1,200 persons for the 45 experienced staffers to be cials and managers at local biomanufacturing plants, hired into the QA/QC organization each year during the PI e DMONT TRIAD BIOPHARMA MANUFACTURING LABOR MARKET ANALYSIS

two-year ramp up period. However, the achievable yield Chemical Engineering or Industrial Engineering to sat- might be less if a biomanufacturer were to insist upon rel- isfy the need for approximately six inexperienced process evant industry experience of the sort described above. development staffers. The community colleges and universities are expected to produce about 1,000 prospective QA/QC employees to sat- Plant Operations isfy a need for just 5 inexperienced new hires per year. Handymen and maintenance workers were reported in gen- 3 erally strong supply in the Triad. However, as we learned Process Development during our earlier analyses of the Eastern North Carolina and Triangle labor markets, instrumentation and control We foresee few difficulties attaining our modest hiring technicians, process technicians and automation engineers goals for process engineers. Triad employers with whom we can be among the most difficult positions to fill. spoke were generally able to source adequate skills locally, though engineers with FDA regulatory experience were BLS & Co projects a potential supply of approximately 400 thought to be more difficult to find. BLS & Co projects experienced plant operations personnel within the Triad a potential supply of more than 900 experienced process laborshed. As our needs are 20 such employees per year we development employees within the Triad laborshed. This anticipate being able to meet our 15:1 hiring standard. surpasses the 210-person applicant pool that results from our desired 15:1 hiring ratio, based on 14 such experienced hires per year during the 2-year ramp-up period. Summary BLS & Co projects that North Carolina’s colleges and The table below provides a synopsis of our project’s tal- universities can supply an annual allotment of approxi- ent requirements and prospective sources of qualified and mately 96 graduates from the Triad who’ve majored in inexperienced workers that have the potential to meet this demand.

Summary of all Sources of Labor: Triad

Target Projected Annual Yield @ Annual Function Total Hires Hires 15:1 Ratio Supply Source of Supply Existing Biopharma Manufacturing Labor Manufacturing/Production 140 70 1,050 4,474 Labor Force QA/QC 90 45 675 1,266 Labor Force Process Development 28 14 210 943 Labor Force Plant Ops/Manufacturing Support 40 20 300 404 Labor Force

Emerging Biopharma Manufacturing Labor BioWork and Manufacturing/Production 60 30 — 77 Community Colleges Community Colleges QA/QC 10 5 — 1,005 & Universities Process Development 12 6 — 96 Universities Community Colleges Plant Ops/Manufacturing Support 0 0 — 423 & Universities PI e DMONT TRIAD BIOPHARMA MANUFACTURING LABOR MARKET ANALYSIS

ates were thought to be just adequately prepared to enter 2. INTRODUCTION the modern workforce.2 It is clear that employers cannot, and do not, take the availability of a skilled workforce for granted when mak- 2.1 Background ing a location decision. It should be equally apparent that any area or region that can boast of an abundance of This report constitutes Biggins Lacy Shapiro & Compa- experienced and skilled workers and the infrastructure ny’s (BLS & Co’s) analysis of the market for biopharma to grow and resupply this valuable resource will have an manufacturing labor in North Carolina’s Triad region; an advantage in the global competition to attract good jobs 4 assessment made from the perspective of a site selector. As and investment. practiced by a site selection firm, labor market analyses typically attempt to quantify the availability and quality of the workforce for an established skill set(s) and at a given 2.2 Organization price point, or wage. Clients use this information to choose This report is organized around the labor requirements between competing destinations for a new project (e.g., a of a 400-employee biopharma manufacturing plant, as new distribution center or manufacturing plant), and/or described in more detail below. For each key function in to help them understand how large they might grow in such a plant (e.g., manufacturing, quality control), we an existing market without jeopardizing their continued have attempted to quantify the available pool of experi- access to qualified labor at affordable wages. enced, skilled workers and the “pipeline” of new talent This analysis was inspired by the desires of those at the being produced annually by North Carolina’s community North Carolina Biotechnology Center and its economic colleges and universities. development partners in and around the Triad to understand if local industry and North Carolina’s extensive post-secondary educational infrastructure have developed 2.3 Methodology a sufficient number of experienced employees and prospec- Our approach to this engagement included the following tive workforce entrants to attract a significant biopharma key activities: manufacturer to the region. This report focuses mainly on the workforce metrics that a new employer would want to • Creating a “proxy” project and labor requirements understand before making a location decision. • Defining the spatial dimensions of the labor market Why this concern about labor markets? In a 2001 survey (the “laborshed”) by Site Selection Magazine 74% of corporate executives • Assessing the availability of experienced biomanufac- said finding available, skilled labor was their biggest chal- turing labor and new workforce entrants lenge and that “labor, whether in a growing or declining economy, still plays a crucial role in corporate location • Reporting findings and making conclusions as to the decisions.”1 However, labor markets in many areas of ability of a new biomanufacturer to compete for its the United States are at risk due to slowing growth and fair share of labor; e.g., to achieve a sustainable labor troubling skill shortages. According pool. to recent studies by the US Bureau of Labor Statistics, the nation’s labor force is projected to grow by only 1% per year, compared with 2.6% during the periods of peak growth in the 1970’s. Over the longer term the Bureau envi- Create Deﬁne Gather Assess Report sions that growth of the nation’s labor Proxy Labor Data Availability Findings force will come to a standstill. Such Project Market trends signal that employers will have Geography to learn to do more with less. How- ever, a 2006 survey by the Conference Board and the Society for Human Resources Management warned that the workforce is wanting: fully 70% of recent US high school graduates had substandard skills and college gradu- PI e DMONT TRIAD BIOPHARMA MANUFACTURING LABOR MARKET ANALYSIS

2.4 Defining the “Proxy” Project and • Process Technician: High School Diploma and rel- Labor Requirements evant experience/training This engagement is somewhat unique from labor market • Formulation/Fill Technician: High School Diploma analyses that BLS & Co undertakes on behalf of its cor- and relevant experience/training porate clients. Without a predefined project requirement • Packaging Technician: High School Diploma and including numbers and types of positions, skills, attributes, relevant experience/training 5 etc., there can be no context for an assessment of the Triad. The solution was to create our own “proxy” project, a • QA/QC: Plays a central role by ensuring products and realistically-drawn fictional entity that will enable us to production processes meet stringent federal manufac- perform a market-based assessment of the region. turing standards. Representative positions include: Our fictitious project was designed with the active input of • Quality Control/Assurance Technician: 2-year Asso- a panel of industry, economic development and academic ciates degree experts assembled for this study by the North Carolina • Quality Control Associate: B.S. degree Biotechnology Center. A fully-integrated plant (fermenta- tion thru fill/finish) was deemed well-suited to our pur- • Process Development: On hand R&D staff to make poses. Project employment was pegged at the high end of improvements and modifications to existing produc- the spectrum, reflecting the prospect demographic that tion processes and identify possibilities for extending has been encountered most frequently by local economic production technologies and applications. developers. The distribution of the workforce is typical • Process Development Associate: 2-year Associates of the life science manufacturing operations known to degree & experience our panelists (and later verified by BLS & Co during field interviews with local employers). This profile is summa- • Process Development Scientist: MS & experience or PhD • Plant Operations: Maintenance workers to ensure the • Fully integrated biologics Type of smooth and continuous functioning of highly complex plant Facility machinery. • Manufactures approved, cell-based drug • Maintenance Technician: High School Diploma and trade certification Employment • Approximately 400 at full • Instrumentation Technician: 2-year Associates buildout degree • 2-year ramp-up Based on our conversations with area employers and BLS Workforce & Co’s previous project experiences, compensation and • 50% Manufacturing/ benefits at our proxy plant have been pegged at the market Production median (50th percentile) in the Triad. We also assume a • 25% QA/AC 15:1 hiring ratio, meaning that employers will make one • 10% Process Development hire for every 15 qualified applicants, this too is based on • 10% Plant Operations project experience and our local interviews. Finally, our • 5% Other [management, manufacturing clients have always voiced a preference for etc.] a non-union labor environment whenever attainable. As North Carolina’s workforce has among the lowest rates rized below: of unionization in the country (2.0% of the private-sector workforce vs. 7.5% nationally), this is not expected to pres- Following are brief position descriptions for key functions ent any serious hiring challenges. within our project:3 • Manufacturing/Production: Combines technical knowledge with procedural accuracy in diverse areas from cell development (for biomanufacturing) to steriliza- tion and chemical mixing (for traditional drug making); also focuses on product finishing and packaging tasks. Representative positions include: PI e DMONT TRIAD BIOPHARMA MANUFACTURING LABOR MARKET ANALYSIS

2.5 Defining the Geographic Scope we ran into data scope and coverage issues—particularly the lack of good occupational data at the highly specific It is important at the beginning of this analysis that we 6-digit SOC code level needed to define the types of jobs determine the boundaries of the targeted geography to be that would exist inside this biomanufacturing facility. The investigated. For the purposes of this study we defined the solution was to base our analysis on aggregated county- Triad biomanufacturing laborshed as that area approxi- level data for the area that most nearly approximates the mating a 45-minute driving distance from four Triad laborshed defined by our custom polygon. This same employment nodes: approach was employed in our labor market analyses of • Greensboro • High Point the Triangle and Eastern North Carolina. The result is a 6 • Winston-Salem • Burlington 12-county region comprising the counties of: It has been our experience that a 45-minute drive is often • Alamance • Caswell the maximum distance that a nonexempt (hourly) worker • Davidson • Davie will travel for a desirable job paying the median wage in • Forsyth • Guilford an area. This general radius was then adjusted to account • Orange • Randolph for trip-to-work idiosyncrasies gathered via our interviews • Rockingham • Stokes with local employers. • Surry • Yadkin When we began planning for these studies we intended Orange County is close enough to the biopharma employ- to define the outermost boundaries of this laborshed by ment centers in Durham and Wake Counties also to be aggregating the four commute zones, thereby creating a considered as part of the Triangle Region laborshed, which customized polygon within which we would then collect was profiled earlier. Though it is considered a part of and analyze various labor data. However, in doing so the Triad region, we elected not to include Montgomery County in the Triad laborshed as none of the employers interviewed by BLS & Co. reported that they draw labor Projected Laborshed: PI e DMONT TRIAD BIOPHARMA MANUFACTURING LABOR MARKET ANALYSIS

from Montgomery County, and the county lies generally • We faced challenges gathering university enrollment beyond the 45-minute drive time to the existing life sci- and graduation data. The data bases of the University ences industry clusters around Winston-Salem, Greens- of North Carolina system are very comprehensive but boro, High Point and Burlington. The map above shows do not report the county of residence of graduating stu- this laborshed (lightly shaded) and our customized poly- dents at the curriculum level. To approximate these data gon as an overlay: BLS & Co used the distribution of student residences reported at the individual university level. 7 2.6 Gathering the Data • We conducted interviews with eleven contract and over- the-counter medicine makers, medical device manufac- For this analysis our data gathering included: turers, clinical diagnostic laboratories, contract research • Primary research, including field interviews with employ- organizations, etc. in the Triad and also with area edu- ers, recruiters, academics and economic development cators, recruiters and economic development officials. A officials in the Triad; and staple of labor market analyses as practiced by BLS & Co, these conversations were very fruitful and yielded • Secondary research, including data describing occupations good information regarding current employment, hir- and academic curricula characteristic of the biopharma ing experiences, turnover, job training, etc. However manufacturing sector in the regional laborshed. Much these discussions cannot substitute for scientifically- of the labor market data needed for this assignment are controlled “surveys” as the sample size is too small available from the major federal data sources (e.g., the and not every respondent was prepared, or willing to Census Bureau, the Bureau of Labor Statistics) as well answer all of our questions. as the North Carolina Department of Labor, the Uni- versity of North Carolina system, the North Carolina Community College System and others. Using these resources BLS & Co began assessing the Triad labor market.

2.7 Data Limitations As is common during these types of engagements, the data sources created analytical challenges, none of which would be considered detrimental to a study of this nature: • For the reasons noted in Section 2.3 above, we aggregated occupational data (SOC codes) for the twelve counties comprising our Triad labor shed. These data are reported by place of work, because place of residence data (which would have been preferred) is not available at this level. We anticipate little impact from this decision to base our “headcount” on where employees work and not where they live. For example, our earlier interviews with employers in the adjacent Triangle region indicated that few recruited biomanufacturing workers from the Triad to any significant degree. • Government privacy laws dictate that labor agencies not publish detailed local data if doing so would disclose information pertaining to only one or two companies. In such situations agencies are required to suppress the data which can frustrate labor market research. For our study these disclosure thresholds were not met for several occupational titles in several counties and con- sequently no data were reported. In these few instances, BLS & Co and its consulting partner, WDG Consulting, derived the estimated employment and wage by trend- ing known reported variables from prior years. PI e DMONT TRIAD BIOPHARMA MANUFACTURING LABOR MARKET ANALYSIS

Also, last fall scientists at Wake Forest University School 3. THE SUPPLY OF of Medicine formed Applied Catheter Technologies based EXISTING BIOPHARMA on new technology that combines pharmaceuticals with catheters to combat narrowing passageways in the body. MANUFACTURING LABOR The technique was pioneered in the Institute for Regenera- tive Medicine at Wake. The Institute, led by Dr. Anthony Atala, recently made news when it announced the success- ful implantation of “manufactured” bladders in human 3.1 Life Sciences Industry Profile in recipients. Tengion, a contract manufacturer in Winston- 8 The Triad Salem, operates a pilot-scale plant that supports the Phase The Triad’s expanding reputation in the life sciences is II clinical trials for the Institute’s engineered organs and due to the presence of a significant cluster of manufactur- limbs. ers of traditional pharmaceuticals, diagnostics and over- Finally, North Carolina A&T State University was recently the-counter medicines and to a growing number of drug chosen to lead a National Science Foundation Engineering discovery firms and service providers that comprise the Research Center (ERC) for biomedical engineering and beginnings of a biologics cluster. ”Traditional” providers nanobio applications. In conjunction with the new ERC, NC A&T will create a new bioengineering department based in the Triad include (among others): that will grant Bachelor’s, Master’s and Ph.D. degrees. • Banner (gel caps) in High Point; And, in March 2009 the N.C. Center of Innovation in Nanobiotechnology was announced in Greensboro. The • BD Diagnostics (cancer screening kits) in Burlington; center’s mission is to promote the commercial develop- • GBF Medical Group (diagnostic kits) in Greensboro; ment of nanobiotechnologies occurring at universities in • MEDTOX Diagnostics (drug testing kits) in Burling- the state. ton; and The North Carolina Biotechnology Center surveyed bio- • Qualicaps (gel caps) in Whitsett pharmaceutical companies as part of its 2003 and 2007 “Windows on the Workplace” training needs assessments. This is a relatively vibrant group. A Burlington-based com- It’s most recent effort found that biopharma manufactur- pany which manufactures process reagents and instruments ing (large molecule, cell-based drugs) had yet to register reported that it plans to move additional production to any measureable employment in the region, however, tra- North Carolina from the Western US in 2009, and Lab- ditional pharmaceutical employment and jobs at pharma- Corp, the diagnostics services giant based in Burlington, ceutical manufacturing service providers were all growing just announced that it has agreed to purchase Monogram more rapidly than the statewide averages between 2002 Biosciences. and 2007. TransTech Pharma, the High Point-based drug discovery company, is one of the Triad’s rising stars. TransTech has a 3.2 Biopharma Manufacturing promising new therapy for female sexual dysfunction and Occupations has attracted more than $300 million via agreements with Pfizer, Merck and Novo Nordisk for potential Alzheimer’s, A key objective of this study is to quantify the supply diabetes and cancer drugs. In 2007 TransTech and its sister of existing, experienced talent with skills relevant or company, PharmaCore were awarded incentives valued at transferable to biopharma manufacturing in the Triad more than $3 million in return for the promise to add 205 region. BLS & Co’s chosen methodology is based on new jobs by 2012. PharmaCore, which was spun-off from occupational data rather than industry or sectoral data. TransTech in 1999, provides contract manufacturing ser- The sector approach would have required using North vices for pharma and biotech drug discovery companies American Industry Classification System (NAICS) codes, in the US and Europe. the standard system of classifying industry adopted by the federal government. The limitations of NAICS codes Targacept is another Triad luminary. In mid-stage clinical are two-fold: 1] the System does not recognize “Biotech- trials its new treatment for depression, called TC-5214, nology” or “Biomanufacturing” as industrial sectors; and significantly improved symptoms of major depressive dis- 2] the System does not discriminate between scientific, order for patients who did not respond to Celexa, an older manufacturing, administrative jobs, etc. drug. The Winston-Salem, N.C., company is in talks with several drug makers to find a partner to help complete To address these omissions we resorted to The US Bureau development of this candidate therapy. of Labor Statistics Standard Occupational Classification PI e DMONT TRIAD BIOPHARMA MANUFACTURING LABOR MARKET ANALYSIS

Table 1: Employment from “Windows on the Workplace,” 2007: Triad

Projected % Change % Change 2002 2007 ‘02–’07 2010 ‘07–‘10 Biomanufacturing Total Statewide 4,415 5,933 34.4% 6,442 8.58% 9 Triad 0 0 0.0% 0 0.00% Traditional Pharmaceutical Manufacturing Statewide 8,808 9,424 7.0% — — Triad 721 791 9.7% — — Pharma Manufacturing Service Provider Statewide 2,374 2,286 -3.7% — — Triad 15 48 220.0% — —

Total Statewide 15,597 17,643 13.1% — — Total Triad 736 839 14.0% — —

Source: North Carolina Biotechnology Center, 2008 (SOC) system, and SOC codes for occupational employ- North Carolina Biotechnology Center staff this crosswalk ment and wage data. The SOC system is the occupational allowed us to narrow our focus considerably by eliminat- classification system used by all federal statistical agencies. ing occupations that had little or no relevancy to biop- It consists of 801 detailed civilian occupations organized harma manufacturing and by enabling us to “drill down” into 22 major groups. Excluded are military occupations, to very specific 6-digit occupational codes for those jobs which are not covered in the Bureau of Labor Statistics that were deemed appropriate to our proxy project. This survey. Because the SOC system does not distinguish bio- approach has resulted in the identification of the follow- manufacturing jobs from other technical and scientific ing SOC codes and occupations as those most frequently occupations we turned to the work performed in 2006 by found in a biopharma manufacturing plant. Please notice the San Diego Workforce Partnership, and in particular, that the functions have been aligned with those used to its “crosswalk” between SOC codes and another, well- characterize the distribution of the workforce in our proxy regarded occupational classification system developed by project in Section 2.4: the Radford Biotechnology Survey. In cooperation with

Biopharma Manufacturing Occupations

Function SOC Code SOC Description Manufacturing/Production 19-4021 Biological Technicians 19-4031 Chemical Technicians 51-1011 Supervisor/Managers of Production/Operating Workers 51- 4011 Computer Controlled Machine Tool Operators 51-8031 Waste Treatment Plant/System Operators 51-8091 Chemical Plant/System Operators 51-9011 Chemical Equipment Operators/Tenders 51-9012 Separating, Filtering, Clarifying, etc. Machine Operators 51-9111 Packaging and Filling Machine Operators/Tenders PI e DMONT TRIAD BIOPHARMA MANUFACTURING LABOR MARKET ANALYSIS

Function SOC Code SOC Description Quality Assurance/Quality Control 13-1041 Compliance Officers, Except Agriculture/Construction 17-2199 Engineers, All Other 19-1021 Biochemists and Biophysicists 19-1022 Microbiologists 19-1029 Biological Scientists, All Others 19-1099 Life Scientist, All Others 10 19-2031 Chemists 19-4099 Life, Physical, Social Science Technicians, All Others 29-2012 Medical and Clinical Laboratory Technicians

Process Development 11-3051 Industrial Production Managers 17-2031 Biomedical Engineers 17-2041 Chemical Engineers 17-2112 Industrial Engineers 17-2131 Materials Engineers

Plant Ops/Manufacturing Support 17-3023 Electrical and Electronic Engineering Technicians 17-3026 Industrial Engineering Technicians 51-4012 Numerical Tool and Process Control Programmers

3.3 Existing Biopharma Skill Base 300 employees; and GoldToeMoretz said it would close its Burlington plant, affecting 430 workers. The BLS & Co approach yields approximately 22,000 persons in 2008 in the Triad employed in occupations that are Based on our recent interviews with employers in the relevant and transferable to a biopharma manufacturing Triad, hiring standards appear to be generally less rigor- plant (see Table 2). ous among some of the region’s contract manufacturers, diagnostics and medical device suppliers when compared The Triad has experienced an overall decrease of approxi- to biologics and traditional pharma manufacturers in the mately 13% in the size of the potential biomanufactur- Triangle and in Eastern North Carolina. For example, a ing labor pool between 2000 and 2008. This finding is Triad-based over-the-counter medicines supplier reported consistent with national and that they have been able to state-wide manufacturing Start with unadjusted pool of skilled and experienced take advantage of the soften- trends and is comparable to employees in relevant occupations. ing economy to hire from dis- the 10% drop that occurred in tressed sectors such as furniture Reduce by 50% to account for the buying Eastern North Carolina (another and textiles and also electronics. NC pharma manufacturing hub), power of an assumed median wage position The Plant Manager volunteered over the same period. Certainly Reduce by 15% for potential that GMP experience, while desired, structural shifts underway in many restrictions on mobility within the is not required and often difficult to of the state’s old line industries such laborshed (e.g., trafﬁc) obtain. He is willing to settle for prior as furniture and textiles, combined with manufacturing experience of any kind. the recent and severe recession, are having 5% discount due to A Triad medical device manufacturer told an outsized impact on the region’s manu- intercept potential BLS & Co that repetitive motion experience facturing workforce. For example, in the last Eliminate ﬁnal is key for his jobs and a local diagnostics kit year HanesBrands announced plans to close 20% for GMP supplier requires only a high school education two plants in Eden (Rockingham County), dis- challenges to qualify for entry-level assembly positions. placing approximately 750 workers; Furniture Brands International reported that the its Henredon/ In the following section we will address how much Drexel Plant #37 in High Point would close, idling of this labor force is available for each functional area PI e DMONT TRIAD BIOPHARMA MANUFACTURING LABOR MARKET ANALYSIS

of our proxy plant. With the assistance of our consulting impact on their commute. This reflects a midpoint partner, Wadley Donovan Gutshaw Consulting, we’ve between the Triangle area and its tendency towards designed the following methodology to derive a market- congestion during peak travel times (20%) and East- driven estimate of the availability of biomanufacturing ern North Carolina, where travel is relatively unen- worksite skills in the Triad: cumbered (10%). These sequential adjustments are based on what we learned 3. We eliminated another 10% based on the likelihood about the region’s labor market dynamics during our inter- that they would pass-up a job at our proposed plant 11 views with area employers: for another, equally attractive opportunity closer to home. 1. As a starting point we assume that our proxy manufacturer will provide compensation at the midpoint of 4. We made our final adjustment (20%) based on the the market in the Triad. Some area employers will pay perceived attractiveness of a job in the biopharma- above the median to attract experienced talent, partic- ceutical manufacturing industry. Employers cited the ularly those in GMP environments such as a contract challenges of working in a GMP environment as one research organization in High Point and a contract of the most significant disincentives to employment manufacturer supporting clinical trials in Winston at their plant. An over-the-counter medicine supplier Salem. However, for most human resources officials interviewed by BLS & Co. attributed much of his vol- and general managers with whom we spoke, the com- untary turnover to frustrations associated with SOPs pensation philosophy was not to exceed the market and paperwork, while a pre-clinical research company median. Doing so effectively prices 50% of the mar- in Winston-Salem reported that they had to resort ket out of our reach—if wages were the sole decision- to out-of-state recruiting because most of the legacy making criterion during a prospective employee’s job R&D staffers from their parent company were unac- search. customed to working in a regulated industry. 2. There was little concern among employers that Triad This methodology results in an accessible pool of approxi- area congestion that could limit a prospective employ- mately 7,500 experienced and skilled employees capable ee’s willingness to commute. To be conservative, we of assuming positions in a biomanufacturing facility. The estimated that 15% of potential applicants would be results for each function in our proxy plant follow. disinclined to accept a particular job due to the adverse

Table 2 : Employment by Biomanufacturing Occupation, 2000—2008: Triad

Year 2000 Year 2008 Change 2000—2008 State State State SOC Description Triad of NC U.S. Triad of NC U.S. Triad of NC U.S.

Manufacturing/ Production 14,400 65,550 1,664,580 13,850 64,670 1,562,360 -3.8% -1.3% - 6.1%

QA/QC 5,510 22,460 739,120 3,920 20,860 761,160 -28.9% -7.1% 3.0%

Process Development 3,475 14,590 439,740 2,920 13,650 423,170 -16.0% -6.4% -3.8%

Plant Ops/ Manufacturing Support 1,770 10,380 332,250 1,250 5,900 254,670 -29.4% -43.2% -23.3%

Total 25,155 112,980 3,175,690 21,940 105,080 3,001,360 -12.8% -7.0% -5.5%

Source: North Carolina Department of Labor—Occupational Employment Statistics (OES), and Equal Opportunity Employment Commis- sion (EEO) 2000 Data. * Derived using multiple data sources—Claritas, EEO and OES. PI e DMONT TRIAD BIOPHARMA MANUFACTURING LABOR MARKET ANALYSIS

3.4 Manufacturing/Production MANUFACTURING/PRODUCTION LABOR SUPPLY DERIVATION The deep and diverse labor pool serving Triad manufacturers should be adequate to support a new biomanufacturing Number Required: 100 per year operation in central North Carolina. In all but the most rig- Number with orous GMP environments, employers interviewed by BLS & Experience: 70 per year (70%) Co. reported little or no difficulty attracting applicants for Number without level 1 or level 2 production technicians or similar positions. Experience 30 per year A High Point-based medicine manufacturer recently received Median Wage and Triad: vs. State: vs. US: Differentials: $39,970 107.6% 98.9% 12 250 applications for 16 open positions, 75 of these applicants were deemed qualified. The company pays at, or slightly Total Experienced below the midpoint for these jobs. A diagnostics kit supplier Pool: 13,850 in Burlington received an average of 30 applications for each Wage Adjustment: - 6,925 new, entry-level technician position advertised recently. A Commute device manufacturer in the Triad regularly attracts 10 or 15 Adjustment: - 1,039 qualified applicants for each entry-level operator position Intercept they post with the N.C. Employment Security Commission. Adjustment - 294 They have never had to advertise a position. Attractiveness On the other hand, a contract research organization man- Adjustment: - 1,118 ufacturing API at a small plant in High Point hired both 4,474 prospective experienced new operators from outside the area due to a lack of Final Yield: applicants necessary skills and experience locally. Paying $50,000 Target Yield at 15:1 to $60,000 on average, this company had no difficulty hiring ratio 1,050 per year recruiting talent to the Triad due to the perceived quality of life in the area. While the manager of a pilot plant in Winston-Salem was able to fill 15 entry-level technician 3.5 Quality Assurance/Quality positions from within the Triad (recruiting successfully Control from Forsyth Technical Community College and Salem Before discussing the supply of QA/QC labor, some clar- College), he expressed deep concern about the region’s ification is in order. Among the device and diagnostic ability to support the production labor requirements of a companies with whom we met in the Triad, quality con- biomanufacturer needing to scale-up quickly—say hire 75 trol is frequently embedded in production and is staffed qualified entry level employees over 6 months. by employees who’ve been promoted from assembly and Once they attract production employees, Triad life sciences operator positions. Often these positions are of the same manufacturers have very little difficulty keeping them. grade as operators and the educational requirements Voluntary turnover generally ranges from 5% to 10% for rarely exceed an Associate’s degree (the final supervisor most operator positions, entirely within acceptable norms will likely have a BS degree). Whereas the over-the-coun- based on BLS & Company experience. One company ter medicine suppliers, contract manufacturers and pre- interviewed did report substantially higher turnover levels clinical research companies with whom we spoke, tend to and also attendance and performance issues within their employ more educated and experienced biologists, chem- very lowest job grades. However this company demands ists, GMP analytical chemists and chemical technicians very little experience and pays basic assembly workers similar to biopharma manufacturers in the Triangle and less than $8 hour to start. Overall, the Triad employers Eastern North Carolina. with whom we spoke consider the quality of new hires to Our data indicate that the Triad region’s supply of experi- generally be very good. enced QA/QC workers should be adequate to staff a new, BLS & Co projects approximately 4,500 potential applicants large biomanufacturing operation, and those employers for the 140 manufacturing/production positions requiring filling QA/QC positions from the operator/technician ranks previous experience. As these jobs would be filled at the are quite satisfied with the supply. However, several area rate of 70 per year, the potential labor supply would well employers who insist upon college degrees and specific skills exceed the target 15:1 hiring ratio. However, we caution such as analytical chemistry were apprehensive because that the market for operators and technicians specifically they had recently encountered challenges filling these posi- skilled or experienced in biomanufacturing processes may tions. A large clinical diagnostic laboratory in the Triad be smaller. The table below summarizes the requirement reported difficulty attracting Technologists and Senior and the derivation of labor supply: Technologists who would certify lab results—they attrib- PI e DMONT TRIAD BIOPHARMA MANUFACTURING LABOR MARKET ANALYSIS

uted their challenges to a nationwide shortage of skilled Triad laborshed. This significantly exceeds the 210-person applicants with chemistry and biology degrees. Similarly, applicant pool that results from our desired 15:1 hiring a pre-clinical research company has had to reduce its stan- ratio, based on 14 such experienced hires per year during dards to recruit QA/QC staffers and no longer emphasizes the 2-year ramp-up period. industrial experience; the same issue confronts a contract manufacturer in the Triad. The good news? They are able PROCESS DEVELOPMENT LABOR SUPPLY DERIVATION to hire undergrad chemists from Wake Forest University, Number Required: 20 per year 13 Winston-Salem State University and Salem College. Number with Experience 14 per year (70%) BLS & Co projects a potential applicant pool of approximately 1,200 persons for the 90 experienced staffers to Number without be hired into the QA/QC organization during the two Experience 6 per year year ramp up period. This represents a reasonably com- Median Wage and Triad: vs. State: vs. US: fortable annual surplus beyond our desired hiring ratios, Differentials: $72,448 100% 90.6% though the achievable yield might be considerably less if Total Experienced a biomanufacturer were to insist upon relevant industry Pool: 2,920 experience of the sort described above. Wage Adjustment: - 1,460 Commute QA/QC LABOR SUPPLY DERIVATION Adjustment: - 219 Number Required: 50 per year Intercept Number with Adjustment - 62 Experience 45 per year (90%) Attractiveness Number without Adjustment: - 236 Experience 5 per year 943 prospective experienced Median Wage and Triad: vs. State: vs. US: Final Yield: applicants Differentials: $60,733 109.9% 99.2% Target Yield at 15:1 Total Experienced hiring ratio 210 per year Pool: 3,920 Wage Adjustment: - 1,960 3.7 Plant Operations Commute Adjustment: - 294 As we discovered during our previous analyses of the East- Intercept ern North Carolina and Triangle labor markets, the hiring Adjustment - 83 margins for Triad instrumentation and control technicians, Attractiveness process technicians and automation engineers are thinnest Adjustment: - 317 of any biomanufacturing occupation we have tested. 1,266 prospective experienced Again, there is a dichotomy in the Triad. Employers includ- Final Yield: applicants ing a medical device company and an over-the-counter Target Yield at 15:1 medicine supplier that hire “handymen” and generalists hiring ratio 675 per year report little difficulty recruiting and retaining operations and maintenance personnel. However, companies needing skilled electricians, maintenance mechanics, electronics 3.6 Process Development technicians, calibration technicians, etc. often contract out BLS & Co. foresees few obstacles to attaining our mod- for this support due to the effort required to attract these est hiring goals for process engineers. Most of the Triad capabilities in the Triad. One interviewee, a member of the employers in our sample are able to find skills locally and Triad Advanced Manufacturing Consortium, recounted from the Triangle, though engineers with FDA regula- complaints of fellow members who were confronting an tory experience and chemical engineers with agricultural aging workforce while younger workers were demanding biotechnology (agbio) experience can be in short supply. (and getting) “huge salaries.” A newly-minted electrician Both North Carolina State University and NC A&T were in the Triad was said to command $18 per hour to start. cited for the quality of their engineering programs and BLS & Co projects a potential supply of about 400 expe- graduates. rienced plant operations employees within the Triad. As BLS & Co anticipates a potential supply of more than 900 our needs are 20 such employees per year we anticipate experienced process development employees within the being able to meet our 15:1 hiring standard. Nonetheless PI e DMONT TRIAD BIOPHARMA MANUFACTURING LABOR MARKET ANALYSIS

employers will have to be creative and willing to pay the prevailing rate ($18 to $21 per hour appears to be the typical starting salary) to hire and retain these in-demand workers.

PLANT OPERATIONS LABOR SUPPLY DERIVATION Number Required: 20 per year Number with Experience: 20 per year (100%) 14 Number without Experience 0 Median Wage and Triad: vs. State: vs. US: Differentials: $46,089 99.8% 93.9% Total Experienced Pool: 1,250 Wage Adjustment: -625 Commute Adjustment: - 94 Intercept Adjustment - 26 Attractiveness Adjustment: - 101 404 prospective experienced Final Yield: applicants Target Yield at 15:1 hiring ratio 300 per year PI e DMONT TRIAD BIOPHARMA MANUFACTURING LABOR MARKET ANALYSIS

the Alamance CC bioprocess certificate program) produced 4. THE SUPPLY OF annually in the Triad as depicted in Table 3, below. EMERGING BIOPHARMA MANUFACTURING LABOR Table 3: BioWork Enrollees and Graduates, 2004-2008: Triad

2004-2008 2004-2008 15 4.1 The Emerging Biopharma Average Average Annual Manufacturing Skill Base Community College Enrollment Completions* The Triad’s emerging biopharma skill base is represented by Durham Tech CC 98 92 enrollees and recent graduates from the state and region’s Guilford CC 1 1 community colleges and university systems (both public and Piedmont CC 24 23 private). Each county in the Triad has, or shares, a community college. The Triad’s major universities include Elon University, Guilford College, High Point University, North Total 123 116 Carolina A&T, Salem College, UNC—Greensboro, Wake Source: North Carolina Community College System Data Ware- Forest University and Winston-Salem State University. house *Note: Completions based on average 94% reported at Wake Tech 4.2 BioWork Enrollment and Course and Wilson CC Completions However, our interviews with several BioWork observers revealed that on average only 40% to 50% of course com- Three institutions in the region (Durham Technical Com- pleters take jobs within the biopharmaceutical industry. munity College, Guilford Community College and Piedmont Thus, we discounted the estimated annual supply of BioWork Community College) offer BioWork, a 128-hour funda- completers in the Triad region to about 50 per year, suffi- mentals course providing entry-level training for the life cient to accommodate our plant’s needs if no other major sciences manufacturing industry designed by the North biomanufacturer were in the job market at the same time. Carolina Biotechnology Center. Because BioWork has only It also bears mentioning that employers in the region are limited barriers to entry it is available to job seekers with not limited to just these three colleges, thus the potential lower levels of education. The majority of BioWork stu- BioWork pool, which averages approximately 840 enrollees dents come from low-paying industries such as retail sales, per year system-wide, can be considerably larger. food service and healthcare support. Many also have been displaced from traditional manufacturing sectors.4 Alamance Community College in Burlington, does not offer 4.3 Biopharma Manufacturing BioWork, but has its own bioprocess-focused certificate Curricula program with five core courses combining Biology and Neither is the emerging labor pool limited to BioWork other sciences with additional lab classes. The program graduates. To quantify the potential supply of Associates typically enrolls 20—25 students per year, though that degree candidates and new undergraduate, graduate and number has increased markedly (80 students now), as the doctoral degree holders BLS & Co and the staff of the economy has worsened. Biotechnology Center identified the academic curricula Graduates of the BioWork program will not be the sole most relevant to biopharma manufacturing. source of inexperienced manufacturing/production work- We used the US Department of Education’s Classification ers available to biopharma manufacturing employers in the of Instructional Program (CIP) coding system, the Radford Triad, but the program can be a valuable contributor. In the Biotechnology Study and the work performed by the San adjacent Research Triangle region a number of employers Diego Workforce Partnership to develop our inventory of give the equivalent of one year’s work experience for any educational programs. This list includes only those codes job applicant completing the BioWork program. for which North Carolina’s community colleges and uni- Earlier we projected that our plant would need to hire 70 versities reported enrollment between 2005 and 2008: experienced manufacturing/production employers each year for two years. The “slots” available to 30 or so less experienced employees could be filled by the almost 120 BioWork course completers (and additional graduates of PI e DMONT TRIAD BIOPHARMA MANUFACTURING LABOR MARKET ANALYSIS

Biopharma Curricula

Function CIP Code CIP Description Manufacturing/Production A21080 Industrial Pharmaceutical Technology (AS) A50110 Chemical Process Technology A50440 Bioprocess Manufacturing Technology (AS)

Quality Assurance/Quality Control A20100 Biotechnology (AS) 16 A20140 Environmental Science Technology (AS) A20180 Industrial Laboratory Technology (AS) 260101 Biology/Biological Sciences 260202 Biochemistry 260204 Molecular Biology 260502 Microbiology 261102 Biostatistics 261201 Biotechnology 400501 Chemistry

Process Development 140701 Chemical Engineering 143501 Industrial Engineering

Plant Ops & Manufacturing Support A35100 A/C, Heating and Refrigeration Technology (AS) A40240 Industrial Engineering Technology (AS) A50100 Biomedical Equipment Technology(AS) A50190 Facility Maintenance Technology (AS) A50240 Industrial Maintenance Technology (AS) D50170 Facility Maintenance Worker (AS) 150612 Industrial Technology/Technician 150613 Manufacturing Technology/Technician 150699 Industrial Production Technologies/Technician

4.4 Community College Enrollment • The Pharmaceutical Center also established the BioNet- work Analytical Training Laboratory which will house BioNetwork is a statewide initiative of the North Carolina lecture and laboratory facilities and provide training Community College System that provides specialized train- to community college students, incumbent workers, ing and equipment to develop the state’s workforce for the collaborating businesses, and educational institutions biotechnology and pharmaceutical industries. BioNetwork seeking hands-on training and experience with the lat- operates two specialized training centers in the Triad: est tools in analytical chemistry. • The BioNetwork Pharmaceutical Center is a statewide In the Triad Forsyth Tech and Alamance CC are the two larg- resource headquartered in Winston-Salem that promotes est providers of biotechnology training; their graduates are workforce development in North Carolina. Initially prized by life sciences companies across the region. Forsyth focused on the pharmaceutical industry, the center now Tech is the lead institution for the National Center for the serves most life science industries through consultation Biotechnology Workforce. With the largest biotechnology and training for companies, service to North Carolina training program in North Carolina, including a two-year community colleges, and job coaching and educational Associate in Applied Science degree in Biotechnology, For- guidance to students and displaced workers. syth Tech also has articulation agreements with nine local community colleges, including Davidson County Commu- PI e DMONT TRIAD BIOPHARMA MANUFACTURING LABOR MARKET ANALYSIS

nity College, Guilford Technical Commu- Table 4: Selected Associate’s Degree Enrollment: nity College, Surry Community College Students from Triad and Rockingham Community College in the Triad, enabling their students to take 2004-2008 a second year of biotechnology training. Average Function CIP Code Curriculum Enrollment Alamance CC has the state’s longest running biotech training program, with almost 200 Manufacturing/ 17 graduates, or approximately 20 per year. Production A50110 Chemical Process Tech 7 The Alamance AAS degree in Biotechnol- Subtotal 7 ogy encompasses basic biotechnology and also bioprocessing training. QA/QC A20100 Biotechnology 348 Those employers who have worked with A20160 Industrial Laboratory Tech 34 the Triad’s community colleges are eager Subtotal 382 to tap this highly qualified student popu- lation to feed their entry-level pipeline. A clinical diagnostic laboratory operating in Plant Ops & A/C Heating & Refrigeration Mfg Support A35100 Tech 168 Burlington hosts Alamance CC’s Medical Technology program on site and hires as A50100 Biomedical Equipment Tech 1 many of the college’s biotechnology grads A50190 Facility Maintenance Tech 29 as possible. A nearby drug diagnostic test A50240 Industrial Maintenance Tech 166 supplier plans to continue employing co-op Subtotal 364 students out of the Alamance biotech program. A Triad medicine manufacturer told BLS & Co that they regularly use Total 753 Guilford Tech’s Industrial Maintenance Source: North Carolina Community College System, BioNetwork Technology program to train skilled maintenance employees; and the manager of a clinical trials pilot plant in Winston-Salem is delighted • Approximately 77 prospective production employees with the capabilities of the 15 technicians recently hired (when BioWork completers and graduates of Alamance out of Forsyth Tech, but was apprehensive that the col- CC’s bioprocessing certificate program are included) to lege might not be able to produce a sustainable supply of satisfy our project’s appetite for 30 inexperienced new new graduates should the biomanufacturing sector really hires per year take-off in the Triad. • 382 prospective QA/QC employees to meet a need for The community colleges serving the 12-county Triad region just 5 inexperienced new hires per year; and enroll an average of 753 students per year in biopharma • 364 prospective plant operations personnel, all of whom manufacturing disciplines. Our research reveals that a will likely require additional experience to be consid- significant number of these enrollees will not complete ered qualified for positions. their degrees in a timely manner, if at all. Among this group are those who will leave college for a new job and fail to complete their degree requirements. Others work 4.5 Undergraduate Degrees full-time while in school and thus may take many years to achieve their degrees. Employers interviewed by BLS & Although some employers fill manufacturing jobs with Co report relatively high levels of satisfaction with these candidates possessing 4-year degrees this is not the norm. non-degree “dropouts,” thus the number of students poten- Generally, the undergraduates receiving biopharmaceuti- tially available to industry should not be limited to those cal-related degrees find themselves in process development who have completed their degree requirements. Below we and quality control positions, depending on the types and amount of industry experience they also have been able to have chosen to reflect Associates degree enrollees rather attain. For these jobs the annual output of North Caro- than graduates in the pool that can satisfy our project’s lina’s public and private universities is more than ample allowance of inexperienced labor. to fill our project’s requirements. Based on these data BLS & Co estimates the community A number of Triad employers who agreed to speak with colleges will be able to produce the following annual sup- BLS & Co. admitted that they were not routinely inter- ply of inexperienced new hires: acting with area colleges and universities. Some say they PI e DMONT TRIAD BIOPHARMA MANUFACTURING LABOR MARKET ANALYSIS

are constrained by hiring requirements—the inability to engineering grads and for the hands-on training offered utilize someone who is fresh out of school with no prior on its 300 liter bioreactor and in its aseptic suites. BTEC work experience. One employer, who tends to hire expe- expects to be able to graduate approximately 100 students rienced engineers from outside North Carolina, remarked in the Biomanufacturing minor once classes are fully sub- that many of their managers were unfamiliar with local scribed. The Center is now graduating more Chemical universities. Engineering students with Biomanufacturing minors than industry is able to absorb in the Raleigh Durham market. Among those Triad life sciences companies that do main- Therefore, as a statewide asset, BTEC will also benefit the tain active liaison with area educators, most appear quite Triad labor market. satisfied with the experience. A device manufacturer has 18 had success hiring biomedical engineers from NC State As employment outcome data were hard to come by BLS University in nearby Raleigh, while a clinical lab operator & Co defined the emerging labor pool as those graduating finds chemistry and biology grads at UNC-Greensboro, students whose permanent address is in the Triad, as well NC A&T, Wake Forest University and Bennett College. as those graduating from colleges in the Triad but actu- UNC-Greensboro was cited for its excellent molecular ally residing elsewhere in the state or beyond. Based on design program (which performs 3-dimensional modeling these parameters, Table 5 below indicates that the sixteen of how a drug is absorbed in the body). schools of the University of North Carolina system plus the region’s six private schools (e.g., Elon University, Guilford Another educational asset nearby is the new Biomanu- College, High Point University, Salem College, and Wake facturing Education and Training Center (BTEC) at NC Forest University), produce almost 800 biomanufacturing- State University. In our earlier report on the Triangle labor related graduates per year for Triad employers. market, local employers lauded BTEC for the quality of its

Table 5: Selected Undergrad Degrees: Triad

Average Annual Degrees: 1999-2007 Grads at Univ’s Function CIP Code Curriculum Grads From Triad* In Triad Process Development 140701 Chemical Engineering 20 18 143501 Industrial Engineering 17 23 Subtotal 37 41

Plant Ops & Mfg Support 150612 Industrial Technology 17 15 150613 Manufacturing Technology 2 0 150699 Industrial Production Tech 7 0 Subtotal 26 15

QA/QC 260101 Biology/Biological Sciences 216 278 260202 Biochemistry 17 12 260204 Molecular Biology 2 4 260502 Microbiology, General 6 0 261102 Biostatistics 2 0 261201 Biotechnology 0 0 269999 Biology/Biological Sciences 0 17 400501 Chemistry, General 60 56 Subtotal 303 367

Total 366 423

Source: University of North Carolina, Academic Planning Inventory, (http://fred.northcarolina.edu/enrindex.html) *Note: Grads from the Triad are based on share (%) of students at each univ reporting Triad counties as residence PI e DMONT TRIAD BIOPHARMA MANUFACTURING LABOR MARKET ANALYSIS

Based on conversations with the chairs of several university 4.6 Graduate & PhD. Enrollment and departments BLS & Co assumes that 25% of these gradu- Degrees ates will pursue additional education while the remainder will enter the labor force, resulting in: Lastly, we considered the potential pool of students graduating with advanced degrees in the biopharmaceutical • Approximately 502 graduates in the Triad who’ve majored disciplines. Even more so than their undergraduate coun- in Chemistry, Biology, Biochemistry, Molecular Biol- terparts, these persons would likely assume either process 19 ogy, etc. to satisfy the small annual need for relatively development or quality control positions, either at a higher inexperienced QA/QC staffers; level, or at the same level but with less actual on-the-job • 58 graduates from the Triad who’ve majored in Chemi- experience. The average number of annual graduates cal Engineering or Industrial Engineering to satisfy available in the Triad (195 total) constitutes a significant the need for approximately six inexperienced process addition to the labor pool. development staffers; and • About 23 graduates who’ve majored in Industrial Tech- nology, Manufacturing Technology, etc. and could step into professional or managerial positions in plant operations and manufacturing support.

Table 6 : Selected Graduate & Ph.D Degrees: Triad

Grads at Univ’s Function CIP Code Curriculum Grads From Triad* in Triad Process Development 140701 Chemical Engineering 8 7 143501 Industrial Engineering 10 11 143601 Manufacturing Engineering 2 0 Subtotal 20 18

Plant Ops & Mfg Support 150612 Industrial Technology 12 24

QA/QC 260101 Biology/Biological Sciences 19 21 260202 Biochemistry 4 5 260204 Molecular Biology 0 1 260401 Cell/Cellular Biology 2 4 260502 Microbiology, General 2 0 260503 Medical Microbiology 3 0 260801 Genetics, General 4 0 261001 Pharmacology 2 3 261004 Toxicology 2 0 261101 Biometry/Biometrics 1 0 261102 Biostatistics 7 0 261201 Biotechnology 1 0 269999 Biological and Biomedical Sci 0 0 400501 Chemistry, General 24 16 Subtotal 71 50

Total 103 92

*Note: Grads from the Triad are based on share (%) of students at each univ reporting Triad counties as residence Source: University of North Carolina, Academic Planning Inventory (http://fred.northcarolina.edu/enrindex.html) PI e DMONT TRIAD BIOPHARMA MANUFACTURING LABOR MARKET ANALYSIS

The Governor’s office and the North Carolina Biotech- 5. CONCLUSIONS nology Center have made biomanufacturing a strategic priority in their efforts to diversify the state’s economy via clean, high-paying jobs. North Carolina’s extensive Table 7 below provides a synopsis of our project’s talent biomanufacturing training capability and infrastructure, requirements and sources of qualified workers or labor which has evolved and grown as a result of these initia- market entrants that have the potential to satisfy this tives, places the state in a strong position to supply the demand. Upon completing this assignment it is our con- relevant skills identified in this study. While this pool will clusion that the Triad regional labor market is capable of feature varying degrees of expertise specific to biomanu- supporting an initial biopharmaceutical manufacturing facturing (some will have direct skills, others will possess 20 plant if scale-up could be managed at pace that would transferable experience) the state and its partners have enable the recruiting, training and development staff to made substantial investments to help bolster the bioman- understand and adjust to local market conditions and to ufacturing labor pool in the Triad and in other targeted assimilate new employees. Ultimately the region should regions around the state. exhibit the capacity to absorb several more of these operations without seriously straining local resources.

Table 7 : Summary of all Sources of Labor: Triad

Emerging Biopharma Manufacturing Labor BioWork and Manufacturing/Production 60 30 - 77 Community Colleges Community Colleges QA/QC 10 5 - 1,005 & Universities Process Development 12 6 - 96 Universities PI e DMONT TRIAD BIOPHARMA MANUFACTURING LABOR MARKET ANALYSIS

REFERENCES

Endnotes 1 “Labor Loosens Up,” Site Selection Magazine, July 2001 21 2 “Learning Curves Ahead.” Site Selection Magazine, August 2007. 3 “Job Creation and the Knowledge Economy: Lessons from North Carolina’s Life Science Manufacturing Initiative.” Nich- ola Lowe, Economic Development Quarterly, November 2007, and Life Science Manufacturing in North Carolina: A Case Study for Workforce Development.” Carolina Context, June 2007 4 “Job Creation and the Knowledge Economy: Lessons from North Carolina’s Life Science Manufacturing Initiative.” Nich- ola Lowe, Economic Development Quarterly, November 2007 For more information, contact: Biggins Lacy Shapiro & Company North Carolina Biotechnology Center Andrew Shapiro William Bullock 47 Hulfish Street Statewide Operations and Economic Development Princeton, NJ 08542 15 T.W. Alexander Drive Phone 609-613-4273 Research Triangle Park, NC 27709-3547 FAX 609-924-8817 Phone 919-541-9366 FAX 919-990-9544 www.ncbiotech.org

Report Date—January 15, 2009 10-003 SO 01/10