Process Development Scientist (Upstream)
Frederick, Maryland
Job Id:
165706
Job Category:
Job Location:
Frederick, Maryland
Security Clearance:
No Clearance
Business Unit:
Piper Companies
Division:
Piper Clinical Solutions
Position Owner:
Brittany Kaplan
Piper Companies is seeking an Upstream Process Development Scientist to support a well-established biopharmaceutical client out of Frederick, MD. The Upstream PD Scientist will be responsible for the development, optimization, and scale-up of upstream bioprocesses used in the manufacture of biologics. This role supports cell line development, media and feed optimization, bioreactor operation, and technology transfer to manufacturing while ensuring robust, scalable, and compliant processes.
Responsibilities of the Upstream PD Scientist:
· Design, develop, and optimize upstream cell culture processes for mammalian (or microbial, if applicable) systems
· Develop and execute experiments for media, feed, and process optimization using DoE approaches
· Operate and scale processes from shake flasks to bench-scale and pilot-scale bioreactors
· Analyze process performance data, identify trends, and recommend improvements
· Support process characterization, robustness studies, and control strategy development
· Author and review technical documents including protocols, reports, SOPs, and regulatory-supporting documentation
· Support technology transfer to GMP manufacturing and provide technical support during manufacturing runs
· Collaborate cross-functionally with Downstream Process Development, Analytical Development, Quality, Manufacturing, and Regulatory teams
Qualifications of the Upstream PD Scientist:
· 6+ years of experience in upstream process development or related role
· Hands-on experience with mammalian cell culture and bioreactor operation
· Knowledge of upstream unit operations, media/feed strategies, and scale-up principles
· Industry experience in biopharmaceutical process development
· Experience supporting IND/BLA-enabling activities
· Familiarity with GMP environments and regulatory expectations
· Experience with high-throughput process development tools and automation
· Bachelor’s degree in science related field (Master’s preferred)
Compensation for the Manufacturing Associate II:
· Salary: $90,000 - $120,000 annually, commensurate with experience
· Comprehensive Benefits: Medical, Dental, Vision (through Cigna), 401k, Sick leave required as by law, PTO, Holidays
This job opens for applications on 5/3/2026. Applications for this job will be accepted for at least 30 days from the posting date.
Keywords:
Upstream, Process Development, PD, Upstream Scientist, Cell Culture, Manufacturing, Bioprocess, Development, Process Characterization, Scale-up, scale up, biologics, GMP, good manufacturing practice, bioreactor operation, bioreactor, tech transfer, manufacture, drug product, mammalian cell culture, shake flask, process optimization, regulatory, CMC, pilot scale, pilot-scale, analytical development, unit operation, media feed, biopharmaceutical, pharma, biotech, large scale, monoclonal antibody, process development, process validation, IND, NDA, PPQ
#LI-BN1
#LI-ONSITE