Job DescriptionThe Upstream Process Development Scientist is responsible for the development, optimization, characterization, and scale-up of upstream bioprocesses supporting the production of biologics, vaccines, cell therapies, or other biotechnology products. This role applies scientific expertise in cell culture, fermentation, media development, and bioreactor operations to improve process performance, product quality, and manufacturing efficiency. The scientist collaborates closely with cross-functional teams, including Process Development, Manufacturing, Analytical Sciences, and Quality, to support technology transfer, process validation, and commercial manufacturing activities. The position requires strong technical knowledge, data analysis capabilities, and a commitment to maintaining compliance with applicable quality and regulatory standards. This role may also contribute to continuous improvement initiatives, troubleshooting efforts, and the implementation of innovative bioprocess technologies.
Essential Duties and Responsibilities- Design, develop, optimize, and scale upstream bioprocesses, including mammalian cell culture, and bioreactor operations, to support research, clinical, and commercial manufacturing objectives.
- Plan and execute process development studies to improve cell growth, productivity, product quality, and overall process robustness using sound scientific and engineering principles.
- Analyze experimental data, and identify critical process parameters to support process understanding, scale-up, and technology transfer activities.
- Collaborate with cross-functional teams, including Manufacturing, Analytical Sciences, Quality, and Process Engineering, to advance development programs and support manufacturing operations.
- Author and review study protocols, technical reports, process descriptions, regulatory documentation, and standard operating procedures (SOPs) in compliance with applicable quality standards.
- Troubleshoot process deviations and technical challenges, implement corrective actions, and support continuous improvement initiatives to enhance process performance and operational efficiency.
- Foster a collaborative, engaged, and team-oriented work environment
QualificationsRequired Education, Experience, Skills and Certifications- Bachelor's or Master's Degree in Chemical Engineering, Biochemical Engineering, Biotechnology, Biology, Biochemistry, Microbiology, Pharmaceutical Sciences, or related scientific discipline.
- Excellent communication skills (oral and written)
- Strong computer, scientific, and organizational skills
- Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
Preferred Education, Experience, Skills and Certifications- Advanced degree in Biotechnology, Biology, Chemistry, Biochemistry, or a related scientific discipline.
- Familiar with cell passaging including vial thaw, inoculation and harvest processes for 5L and 10L bioreactors.
- Certified Biomanufacturing Professional (CBP)
- Lean Six Sigma Green Belt or Black Belt
- GMP or Bioprocess Manufacturing Training Certification
- Proficient with recording data via eLN, following SOPs and validation reports.
- Familiar with GMP and GLP standards.
Work Authorization Requirements- Must be authorized to work in the USA indefinitely without restrictions
Additional InformationThis position is Full-Time,
Sunday-Thursday 8am-5pm. Candidates currently living within a commutable distance of
Malvern, PA are encouraged to apply.
- Excellent full-time benefits including comprehensive medical coverage, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
