Associate Scientist – Process Development, Downstream Catalent Pharma Services

Associate Scientist – Process Development, Downstream

Position Summary

• Shift: Monday – Friday 8am – 4:30pm
• 100% on-site

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.

• 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

• 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

• Competitive medical benefits and 401(k)
• 152 hours PTO + 8 paid holidays
• Dynamic, fast‑paced work environment
• Opportunity to work on Continuous Improvement Processes

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