Manager - Manufacturing Science & Technology, Upstream Tech Transfer

Manager - Manufacturing Science & Technology Upstream Tech Transfer

Summary

Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients.

The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI, and our market-leading biologics analytical services in Kansas City, MO and Research Triangle Park, NC, as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA.

Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent.

Working for Catalent Biologics is an opportunity to join an entrepreneurial team. Catalent Biologics is making significant investments in people and capabilities.

This is a unique opening to join a small, fast-growing business, backed by a global public company. People joining our team will have the opportunity for career development as our business continues to grow and expand.

Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat COVID-19, cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart and lung diseases as well as Alzheimer’s.

The Manufacturing Sciences and Technology (MS&T) department’s primary function is to serve as an agile technical services team to support process & technology transfer (e.

g., mAbs, fusion proteins, mRNA, new modalities, etc.), equipment, consumables, technical writing, and drug substance lifecycle management.

The MS&T organization supports the Madison facility as well as the Catalent Biologic’s network through client-facing support, on-the-floor or on-call technical coverage, and continuous improvement.

The Upstream and Downstream Technical Transfer groups are the technical liaisons between Process Development (internal or external) and at-scale GMP manufacturing relating to process transfer.

This function includes drafting and supporting required batch documentation (i.e., gap assessments, reports, batch records, product impact), as well as process modeling and facility fit including initial bill-of-material development.

This is a full-time on-site position, Monday Friday 8 : 00am-5 : 00pm

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.

The Role

• Lead a team in technical support of Manufacturing, including the technology transfer between external clients or Process Development and Manufacturing.
• Lead a group of engineers, scientists, and other colleagues to drive the facility fit and technical transfer of mammalian biologic processes.
• Responsibilities associated with the evaluation, alignment, and recommendation of equipment and process improvements.
• Support technology transfer of processes into manufacturing for both internally and externally developed processes.
• Works cross functionally with Process Development, Manufacturing, Quality Assurance, Quality Control, Supply Chain, Project Management, Facilities and other departments to effectively transfer and maintain processes in the facility.
• Works closely with manufacturing to author appropriate batch documentation and provide technical and strategic oversight associated with GMP manufacturing.
• Evaluate existing processes and identifies process or equipment improvements to advance efficiency, consistency, and competitiveness within the market.
• Authors and reviews documents including batch production records, tech transfer reports, bill of materials, process descriptions, project reports, engineering specifications and summary reports.
• Act as the lead for technical support of risk assessments, gap analysis, deviations, change controls, and CAPAs including determination of product or process impact, root-cause analysis, and corrective action identification.
• Responsible for maintaining a high-performing team by hiring, training, motivating, evaluating, and developing staff (direct reports and others).
• Other duties as assigned.

The Candidate

• Bachelor's degree in a STEM discipline and 9+ years related experience, OR Master's degree in a STEM discipline and 7+ years related experience, OR Doctorate Degree in a STEM discipline and 4+ years related experience
• Direct personnel and organizational group management experience, including mentoring and training staff members cross-functionally required.
• Minimum of 3 years’ experience in a people leadership role preferred.
• Ability to work with and lead other groups to develop, qualify, and transfer methods and drive complete investigation, deviation, and change control practices.
• Strong technical knowledge and hands-on experience with biological manufacturing and validation concepts and procedures in a GMP environment.
• Influential leader / SME of Upstream (mammalian cell culture) or Downstream (e.g., depth filtration / clarification, chromatography, tangential flow filtration, viral filtration, BDS fill, etc.

manufacturing processes across cGMP biologics production scales required.

• Experience in facility fit, process scaling, and technology transfer preferred. Experience working on late phase, process performance qualification, and commercial programs is a plus
• Excellent written and verbal communication skills with internal and external customers.
• Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, GM Excellence, and GROW) may be considered in place of external experience.

Physical Requirements

• Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening.
• Occasional stooping, kneeling, crouching, bending, carrying, grasping.
• Frequent lifting and / or moving up to 10 pounds and occasional lifting and / or moving up to 50 pounds.
• Must comply with EHS responsibilities for the position.
• Working in a lab environment will require working with skin irritants, lung irritants, electrical equipment, sharp instruments, toxic materials, and hazardous waste.

Safety procedures must be followed to minimize exposure, including proper use of PPE (personal protective equipment) and clean room gowning.

Working conditions will be Heating Ventilation and Air Conditioned controlled.

Why you should join Catalent :

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• 152 hours of paid time off annually + 8 paid holidays
• Competitive salary with yearly bonus potential
• Community engagement and green initiatives
• Generous 401K match and Paid Time Off accrual
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world.

Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.

Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work.

Visit to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to .

This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.

S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives : Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and / or search firms for this job posting.

Resumes submitted to any Catalent employee by a third party agency and / or search firm without a valid written & signed search agreement, will become the sole property of Catalent.

No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

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If you receive any such request, DO NOT respond it is a fraudulent request. Please forward such requests to for us to investigate with local authorities.

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