Director - Process Development, Upstream

Director Upstream Process Development

Position Summary

Catalent Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop manufacture and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma biotech and consumer health customers supporting product development launch and full lifecycle supply. With timetested experience in development sciences delivery technologies and multimodality manufacturing Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites Catalent supplies billions of doses of lifeenhancing and lifesaving treatments for patients annually.

Our new stateoftheart Madison WI facility with expanded mammalian cell line engineering and biomanufacturing capabilities utilizing singleuse systems offers increased flexibility and manufacturing scale to support our customers growth. We offer a broad range of integrated formulation and analytical services to solve your most difficult development challenges in Biologics.

The Director of Upstream Process Development will lead the upstream process development team in designing optimizing and scaling up robust efficient and reproducible cell culture processes for biologics manufacturing. This role is critical to ensuring the successful development and tech transfer of processes for clinical and commercial production meeting client expectations regulatory requirements and internal quality standards. The Director of Upstream Process Development will collaborate crossfunctionally with downstream process development analytical development manufacturing quality and clientfacing teams to deliver highquality biologics within timelines and budgets.

The Upstream Process Development team is responsible for the development and implementation of mammalian cell culture upstream processing methodologies and analytical procedures that can be successfully transferred to cGMP manufacturing to generate therapeutic proteins for human clinical trials. The unit operations process parameters and process information to be developed executed and transferred include but are not limited to seed train scaleup and production bioreactor inoculation specifications and setpoints specific process parameter monitoring and data collection requirements media and feeding strategies and harvest criteria. The process development experiments involved with this research range from highthroughput Design of Experiment (DoE) formats for clone screening and process optimization to pilotscale Single Use Bioreactor (SUB) toxicology or engineering nonGMP runs to support cGMP manufacturing. To support this research the team members also contribute to a variety of lab support areas including equipment maintenance raw materials management and investigation support; the project experiment designs and results are routinely communicated with external clients and internal functional areas to ensure the quality of the final process.

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 mentor and develop a team which may include principal level scientists scientists and engineers specializing in upstream process development fostering a culture of innovation collaboration and accountability.

• Set strategic goals for the upstream process development group aligning with company objectives and client deliverables; Manage resource allocation project prioritization and team capacity to meet multiple concurrent client projects.

• Direct the development of scalable processes to support optimal expression purification and product quality attributes for both antibodies recombinant proteins or other biomolecules.

• Oversee the design and development of upstream processes for mammalian cell lines (e.g. CHO HEK293) used in biologics production.

• Optimize cell culture conditions bioreactor operations and feeding strategies to maximize product yield quality and consistency while minimizing costs.

• Understand and be able to implement advanced technologies such as perfusion fedbatch or continuous processing to enhance process efficiency and scalability.

• Utilize Design of Experiments (DoE) highthroughput screening and process analytical technologies (PAT) to drive datadriven process optimization.

• Lead scaleup activities from laboratoryscale bioreactors (e.g. Ambr250 to 2L10L) to pilot/engineering/confirmationscale (e.g. 50L250L) and commercialscale bioreactors (e.g. 2x 2000L) and collaborate with manufacturing teams to ensure seamless technology transfer of upstream processes to GMP facilities.

• Ensure all upstream processes comply with global regulatory guidelines (e.g. FDA EMA ICH) and are suitable for IND BLA or equivalent submissions; Author review and approve technical reports process development summaries and regulatory filing sections (e.g. CMC).

• Serve as the primary technical point of contact for clients on upstream process development providing regular updates technical expertise and strategic recommendation and collaborate with business development and project management teams to scope projects define timelines and prepare proposals or statements of work

• Other duties as assigned.

The Candidate

• Bachelors degree in a STEM discipline and >15 years related experience OR Masters degree in a STEM discipline and >12 years related experience OR Doctorate degree in a STEM discipline and >8 years related experience and >6 years of leadership experience.

• Ability to combine and interpret data from multiple disciplines and has a commanding understanding of the full Biologics process.

• Experienced in all aspects of drug development and lifecycle support and able to develop useful strategies and tactics to meet regulatory milestones.

• Excellent written and verbal communications skills and ability to communicate complex technical information to nontechnical audiences.

• Ability to lead difficult discussions with customers and subordinates and drive the conversation to an acceptable resolution.

• Detail oriented with ability to work effectively under high pressure with multiple deadlines within a fastpaced environment.

• Demonstrable leadership experience at Catalent (including but not limited to participation in Catalentsponsored leadership programs such as NGGL GOLD LEAD Now GM Excellence and GROW) may be considered in place of external experience.

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

• Dynamic fastpaced work environment.

• 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 7000 lifesaving and lifeenhancing 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 Catalent Careers 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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