Associate Scientist - Process Development, Downstream

Associate Scientist - Process Development, Downstream

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 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 Associate Scientist – Process Development is responsible for supporting the development and optimization of biologic manufacturing processes, including upstream cell culture and downstream purification activities. This role executes laboratory experiments such as seed train scale-up, bioreactor operations, and protein purification while applying standard statistical methods to analyze data and improve process performance. The Associate Scientist will maintain accurate documentation in accordance with SOPs and GMP practices, support tech transfer to manufacturing, and collaborate cross-functionally with internal teams and external clients to ensure successful project delivery in a fast-paced, client-driven environment.

The role:

• Execute laboratory experiments supporting upstream process development, including cell bank vial thaws, seed train scale-up, and bioreactor operations
• Perform cell culture analytical methods and apply platform processes with moderate modification to optimize productivity and product quality
• Analyze experimental data using standard statistical methods, including Design of Experiments (DoE)
• Support downstream purification activities, including chromatography (AKTA), filtration, and tangential flow filtration
• Maintain accurate documentation and batch production records (BPRs) in accordance with SOPs and GDP requirements
• Collaborate cross-functionally and communicate results with internal teams and external clients to meet project timelines
• Support lab operations, including equipment maintenance, cleaning, material stocking, and 5S organization
• Contribute to process development, optimization, and continuous improvement initiatives across client and internal programs

The candidate:

• Bachelor's degree in a STEM discipline with 1–3 years of related experience
• Equivalent technical competency may also be demonstrated through completion of a bachelor's degree in Chemical Engineering or a closely related discipline with relevant laboratory, research, or co-op experience
• Ability to execute laboratory procedures and experiments of moderate complexity with minimal guidance
• Hands-on experience or exposure to cell culture, bioreactors, or downstream purification (chromatography, TFF, AKTA)
• Experience with data analysis and statistical methods (e.g., DoE) and ability to interpret results
• Experience working within GMP/regulatory environments, including SOPs, GDP, and batch record (BPR) documentation
• Ability to identify out-of-spec data, troubleshoot issues, and support investigations
• Strong organization, communication, and ability to manage multiple priorities in a fast-paced environment
• Experience supporting lab operations (equipment maintenance, cleaning, stocking, 5S) and working cross-functionally

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.