Senior MSAT Engineer — Sterile Fill-Finish Tech Lead
PSC Biotech
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Benefits offered by this job
Job summary
PSC Biotech in York, United States, is seeking a Senior MSAT Engineer to support formulation development, compounding process design, technology transfer, scale-up, and commercial manufacturing readiness for sterile injectable products.
The successful candidate will lead drug product formulation activities, collaborate with Manufacturing, Quality, Validation, and Regulatory teams to ensure robust, scalable aseptic processes from early development through commercial production; strong GMP
Qualifications
- Bachelor of Science in a chemical/biotech field required.
- 7+ years of experience in drug product manufacturing and pharmaceutical process development.
- U.S. work authorization; No C2C allowed.
Responsibilities
- Lead formulation assessment and process transfer activities from client organizations.
- Review development reports, formulation histories, and manufacturing records.
- Support development and optimization of sterile injectable formulations.
- Identify CPPs and CQAs and ensure process robustness and scalability.
- Prepare process transfer documentation and participate in regulatory submissions as needed.
Skills
Education
Job description
PSC Biotech in York, United States, is seeking a Senior MSAT Engineer to support formulation development, compounding process design, technology transfer, scale-up, and commercial manufacturing readiness for sterile injectable products.
The successful candidate will lead drug product formulation activities, collaborate with Manufacturing, Quality, Validation, and Regulatory teams to ensure robust, scalable aseptic processes from early development through commercial production; strong GMP
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