Job Description

Principal Scientist - Process Development, Upstream

• Shift: Monday – Friday 8am-5pm
• 100% on-site

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 life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality 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 life-enhancing and life-saving treatments for patients annually.

The Principal Scientist - Process Development, Upstream 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 clinical trials. This role will lead and execute complex process development activities including seed train scale-up, bioreactor operations, and process optimization using Design of Experiments (DoE), while supporting tech transfer to manufacturing. The individual will operate as a technical lead across multiple projects, collaborating cross-functionally and with external clients to ensure robust, scalable processes and successful delivery across early-phase through late-stage development programs

The role:

• Lead the development and implementation of mammalian cell culture upstream processing methodologies and analytical procedures for transfer to cGMP manufacturing
• Troubleshoot and problem solve process issues, initiate and execute corrective actions, and monitor outcomes to ensure successful project completion
• Design and execute process development experiments including seed train scale-up, bioreactor inoculation, and production operations
• Apply Design of Experiments (DoE) for clone screening, process optimization, and defining process parameters and operating conditions
• Support tech transfer activities to manufacturing, ensuring processes are robust and can be successfully transferred to cGMP manufacturing
• Lead multiple complex projects at a time and serve as a technical lead providing scientific consultation and direction
• Analyze and interpret complex data, integrate experimental results with project objectives, and provide insight into potential issues and solutions
• Collaborate with internal functional areas and external clients to communicate project status and ensure delivery of high-quality processes

The candidate:

• Ph.D. in Biotechnology or related field with 8–10 years of laboratory experience, OR MS with 12+ years, OR BS with 15+ years of industry experience
• Experience in development and implementation of upstream process development methodologies, including mammalian cell culture and bioreactor operations
• Hands-on experience with process development, scale-up, and transfer of processes to cGMP manufacturing
• Strong knowledge of Design of Experiments (DoE), process optimization, and process parameter definition
• Experience working in a cGMP environment and applying good documentation practices (GDP)
• Ability to independently design, execute, and analyze experiments, interpret complex data, and provide insight into potential issues and solutions
• Ability to troubleshoot and problem solve complex process issues, analyze data, and initiate and execute corrective actions
• Strong technical writing skills with experience authoring SOPs, batch records, protocols, and technical reports
• Ability to lead multiple complex projects, communicate effectively with internal and external clients, and provide technical leadership and mentorship

Why you should join Catalent:

• Competitive medical benefits and 401K
• 152 hours PTO + 8 Paid Holidays
• Dynamic, fast-paced work environment
• Opportunity to work on Continuous Improvement Processes

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 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 DisabilityAccommodations@catalent.com 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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