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Request for Information
Catalent Drug Substance Operator Talent Pipeline
To:
From:
Education Partners
Ascend Indiana + Catalent
Response Requested by September 14, 2018
1
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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125 125
0
20
40
60
80
100
120
140
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2017 2018 2019 2020 2021 2022
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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135
0
20
40
60
80
100
120
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160
180
2014 2015 2016 2017
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
([email protected]) 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.