Request for Information

Catalent Drug Substance Operator Talent Pipeline

To:

From:

Education Partners

Ascend Indiana + Catalent

Response Requested by September 14, 2018

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Purpose

Catalent, formerly Cook Pharmica, is seeking a 4-year education partner to co-create a sustainable pipeline of 25-30 early-in-career drug substance operators annually who have a background in biology, chemistry, or biochemistry.

This Request for Information (RFI) provides an overview of the project, as well as the process for

education partner selection. Education providers interested in supporting Catalent with the creation

of a talent program should respond by providing the information highlighted in the guidelines

section in a Word document by September 14, 2018.

Introduction

Biotherapeutics and Biologics

Drug substance operators facilitate the production of biologics worth millions of dollars each

year that provide life-saving treatment to patients worldwide and are integral to Catalent’s drug

substance operations. The development of biopharmaceutical products has led to the development

of treatments for previously untreatable conditions that are more effective with fewer side effects.1,2

Biotherapeutics is the fastest growing sector in the pharmaceutical industry with an annual growth

of more than 8%, which is double the growth rate of conventional pharmaceuticals.3 By 2020, it is

projected that biologics will account for more than 25% of the pharmaceutical market.4 As Catalent

continues to expand their production of critical biologic treatments, the company needs the talent to

sustain its growth.

Drub Substance Manufacturing

Drug substance manufacturing (DSM) is the creation of an active pharmaceutical ingredient, which

is a therapeutic protein that is administered to a patient for a specific condition. The manufacturing

process begins with thawing a frozen vial containing cells that have been programmed to produce the

therapeutic protein and inoculating those cells into growth media. As the cells divide and grow, they

are transferred into a series of larger vessels, and ultimately into agitated tanks of several thousand

liters. The cells are then removed, and the protein, which remains in the media, is purified through

several steps. The purified material, known now as drug substance, is filled into containers and stored. 1 Walker, N. (n.d.). Biologics: Driving Force in Pharma. Retrieved June 21, 2018, from https://www.pharmasalmanac.com/articles/biologics-driving-force-in-pharma2 Otto, R., Santagostino, A., & Schrader, U. (n.d.). Rapid growth in biopharma: Challenges and opportunities. Retrieved June 21, 2018, from https://www.mckinsey.com/industries/pharmaceuti-cals-and-medical-products/our-insights/rapid-growth-in-biopharma3 Id.4 2018 Global life sciences outlook Innovating life sciences ... (n.d.). Retrieved June 21, 2018, from https://www.bing.com/cr?IG=7BBF565012414FA5931F8697788EB6D9&CID=3AD22D85726D68091E8E2199739069BC&rd=1&h=eHAJ-Q7xyqWvRW-wPyJ-975rgpX0bAP35TqX-ncNNy4&v=1&r=https://www2.deloitte.com/content/dam/Deloitte/global/Documents/Life-Sciences-Health-Care/gx-lshc-ls-outlook-2018.pdf&p=DevEx.LB.1,5528.1

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Drug substance operators work across two functional DSM areas, upstream and downstream, to grow

and harvest live cells. The drug substance will later be used to prepare the final dosage form, known as

drug product, which will be administered to the patient.

Drug Substance Operator Talent Program

The drug substance operator talent program will provide students with significant career

development opportunities at an innovative, multinational company while playing a critical role

in the production of these biologic treatments. Students in the program will receive scholarships,

training, work-based experiences, and have the opportunity for employment upon graduation.

Ultimately, the program will align employer and education provider work-and-learn opportunities

and lead to increased individual and economic prosperity.

Catalent currently partners with Ivy Tech Community College (Ivy Tech) and their Biotechnology

Program to build their talent pool. The Biotechnology Program provides graduates with laboratory

and hands-on experiences as a foundation for a drug substance operator role. Catalent is looking

to establish a talent pipeline that complements Ivy Tech’s Biotechnology Program and creates an

expanded pathway for students to graduate with their bachelor’s degree. Interested education

partners must be willing to accept transfer students from Ivy Tech’s Biotechnology Program.

Partnership Overview

Catalent is the leading global provider of advanced delivery technologies and development solutions

for drugs, biologics and consumer health products. Catalent has proven expertise in bringing more

customer products to market faster, enhancing product performance and ensuring reliable clinical

and commercial product supply with over 80 years serving the industry. The company employs over

11,000 people globally at more than 30 facilities across five continents. In 2017, Catalent generated

over $2 billion in annual revenue.

Catalent Biologics works alongside leading biologic and biosimilar developers on the next

generation of biologics products by utilizing a suite of proprietary technology platforms and a

range of development, manufacturing, and clinical supply services. Catalent Biologics is central

to the company’s growth. The recent acquisition of Cook Pharmica in Bloomington strengthens

the Catalent Biologics global network, and includes a state-of-the-art facility, which has extensive

bio-manufacturing capacity. The development of a steady talent pipeline is fundamental to the

expansion of the Bloomington facility and the rest of Catalent’s global operations.

Catalent engaged Ascend to support their talent pipeline efforts. Ascend is the talent and workforce

development initiative of Central Indiana Corporate Partnership (CICP), an organization that brings

together industry, higher education and philanthropic leaders to advance our region’s prosperity and

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growth. Ascend’s vision is for every Indiana employer to

have access to the skilled workforce necessary to thrive and

for every Indiana resident to have the opportunity to pursue

a meaningful career. To achieve this, Ascend bridges talent

and communication gaps by creating connectivity between

people and employers. Ascend has focused its efforts around

three core priorities: connecting job seekers to career opportunities

through the Ascend Network talent platform, providing strategic consulting to

address labor market and talent development gaps through Ascend Services, and

informing workforce research and public policy through thought leadership.

Project Context

Relevant information around demand (jobs), supply (talent), and the misalignment between them

is discussed below to demonstrate the need for developing the drug substance operator program.

Demand

Catalent currently runs one

production line with a staff

of approximately 30-40

people within its Bloomington

facility. Catalent needs talent

to appropriately staff their

current line and expand their

operations to accommodate

additional drug substance

production lines to meet rising

customer demand. Catalent

projects the need to hire

an additional 25-30 people

annually to accommodate growth, turnover, and career progression of current drug substance

operators. By 2022, Catalent projects the need for an estimated 125 drug substance operators to

staff all production lines.

The operator role requires a background in science, such as biology, chemistry, or biochemistry, and

hands-on experiences related to bio-manufacturing. The job also requires independent judgment,

critical thinking, collaboration and teamwork, attention to detail, and communication. Traditionally,

this job requires someone with a minimum of an associate’s degree plus relevant experience.

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CATALENT DRUG SUBSTANCE OPERATOR DEMAND

Actual Projected

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However, given the complexity and financial implications associated with this role, Catalent would

like to see this role require a four-year degree.

Supply

Catalent currently employs 30-40 people in the operator role. Current staff are mostly male,

non-minority, experienced in production, and have an associate’s degree or significant industry

experience. New staff can take

12-18 months to train once

hired, which costs Catalent

significant time and resources.

Currently, Catalent utilizes

internal groups as a feeder

to fill their upstream and

downstream needs. However,

these employees typically lack

the appropriate skillsets to

meet the more complex needs

of upstream and downstream

activities. Additionally,

Catalent’s partnership with ITCC’s Biotechnology Program is utilized as another source of talent. The

Bloomington program had 135 new students enroll in 2017.

Misalignment

Given the complexity of the role, the growing demand for biologics production, and Catalent’s

production line expansion, Catalent would like to partner with an education institution to create

a skilled and diverse drug substance operator talent pipeline. Catalent projects the need for an

additional 25-30 operators annually in the coming years.

Impact

The misalignment between demand and supply is impacting Catalent’s ability to effectively staff for

their current production needs and expand its capacity to produce biologics to meet market demand.

Program Overview

Vision

Establish a stable pipeline of Indiana talent for biologics manufacturing career professionals who meet

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IVY TECH BIOTECHNOLOGY STUDENT ENROLLMENTS BLOOMINGTON

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the needs of Catalent’s clients and patients worldwide while bolstering the local and state economy.

Mission

To provide access to high-paying jobs, hands-on experience, tuition support, and mentorship for

sustained career success. Through this program, Catalent will be able to expand availability of

biologic therapies to patients worldwide.

The focus of this project is to develop an early-in-career pathway for 25-30 drug substance operators

annually. To achieve this goal, Catalent will identify and partner with an education provider and

adapt its curriculum to train and produce highly-skilled, career-ready talent to fill the drug substance

operator position. This talent pathway will give participants critical knowledge, experience, and

tuition assistance in exchange for a work commitment that will lead to a long-term career with a

leading pharmaceutical company in drug delivery technology and development.

Employer Engagement

Catalent will engage with students and the selected education partner in a variety of ways to

support the development of this program. Catalent is an active supporter of programs that

provide opportunities for high school students to explore biotechnology as a career path. Catalent

currently sponsors five area high school biotechnology programs through course support, teacher

development, and industry and education partnerships. Catalent also partners with Regional

Opportunities Initiatives (ROI) to support other high school education initiatives in their community.

These programs will significantly expand in the coming years through Catalent’s continued support

and serve as a critical recruitment opportunity.

Alongside the selected education partner, Catalent will support curriculum development and

modification across the life cycle of the student to ensure they are building the knowledge and skills

necessary to be successful. Additionally, Catalent is willing to contribute adjunct faculty to support

student learning. Catalent will provide hands-on job experiences through site visits, internships, and

co-op rotations at Catalent.

Program Benefits

A successful partnership between Catalent and an education provider will have significant benefits

for all parties involved. Students will have access to a comprehensive program that will serve as a

catalyst for student success through robust curricular and work-based experiences preparing them

for a career in biotechnology. By taking classes and receiving tangible work experience in parallel,

participants in the program will earn a valuable four-year degree while securing post-graduation

employment at a leading life sciences company. Moreover, the program will prepare them for

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success both in the drug substance operator role as well as for future career opportunities at

Catalent in manufacturing, quality, process development, manufacturing sciences, sales, and many

more functions. Catalent is committed to supporting students financially throughout their education

to reduce students’ education expenses.

Alongside the benefits for students, the selected education partner will develop a strong partnership

with Catalent, a life sciences industry leader. Catalent is dedicated to supporting the education

partner in shaping the curricular experience and providing content experts, adjunct faculty, and

potential training facilities. This will yield a direct connection between the university and the skills

demanded by employers in a rapidly changing economy. Additionally, the program will be an

innovative partnership to market to prospective students, increase student placements, and serve as

a steady source of talent from Ivy Tech who are well-prepared to complete their bachelor’s degree

and motivated to exceed expectations.

Life sciences is a critical industry for Indiana and this program will support the continued growth

seen over the past five years. Bloomington is the number one small Metropolitan Statistical Area

(MSA) in the country for medical device and equipment employment concentration and fourth in

the country for drugs and pharmaceuticals employment concentration. This program will support

the development of talent for the industry leaders driving this growth and ultimately benefit the

communities where these organizations operate.

Request for Information Guidelines

Education Partner Criteria

Catalent has identified the criteria necessary for an education partner to successfully develop the

drug substance operator pipeline. These criteria fall into the categories of coursework, faculty and

administration, finances, location and facilities, and program characteristics. Catalent would like

programs to have coursework in biology, chemistry, chemical

engineering, and biotechnology alongside problem-solving

skills and lab experience. Additionally, Catalent would prefer

programs with manufacturing-related experiences that focus

on good manufacturing practices (GMP).

Please respond in a Word document with an overview of

your biology, chemistry, biochemistry, and/or biotechnology

program that includes evidence based on the criteria listed

below. If you have any questions, please do not hesitate to

reach out.

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Partner Information

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Next Steps

Selection Process

Potential education partners should submit their response to Stephanie Bothun

(stephanie.bothun@ascendindiana.com) by September 14, 2018. Once responses have been

received, Ascend will schedule a meeting with Catalent and the interested party to review their

candidacy. At that time, an opportunity to tour the Catalent facility will be made available. After

Ascend and Catalent review potential education partners, Catalent will select the partner that best

suits the needs of the drug substance operator pipeline. The selected education provider will then

meet with Catalent to align on a memorandum of understanding (MOU) to move forward with the

partnership. The selection process will be completed by October 2018.

Meeting Request Share RFI Secure

RFIs

Interview Potential Partners

Select Education

PartnerSign MOU

Once the MOU is signed, Catalent, Ivy Tech, Ascend, and the education partner will enter a planning

phase to develop the program content, which will take approximately seven months beginning in

October 2018. Ascend commits to planning and creating materials for meetings, thought partnership

in program design, as well as project management. Catalent and the education provider can expect

to commit significant staff time to gathering data, attending planning meetings, securing internal

investment and approval, and preparing for program launch. Catalent is eager to begin developing

the talent pipeline as soon as possible.

Thank you for your consideration. We look forward to meeting with you.