Senior Scientist / Principal Scientist, Aseptic Fill Finish Operations
About The Position
Transpire Bio Inc., a clinical-stage biopharmaceutical company specializing in inhalation formulation and delivery platforms, is seeking a highly skilled Senior Scientist or Principal Scientist to lead and manage aseptic fill-finish operations for sterile drug products. The role calls for 7–10 years of hands-on aseptic processing experience in a GMP environment and a strong background in process development, scale-up, and technology transfer. The successful candidate will apply deep knowledge of aseptic techniques and regulatory compliance while ensuring product quality and sterility assurance. The position leads the development, optimization, and scale-up of aseptic fill-finish processes, oversees transfer from development to commercial manufacturing, resolves manufacturing issues, and prepares and reviews technical documentation. The role works cross-functionally with Quality Assurance, Quality Control, Engineering, and Regulatory Affairs, and mentors junior scientists and technicians.
Requirements
- Advanced degree (MS or PhD) in Pharmaceutical Sciences, Chemical Engineering, Biotechnology, or a related field.
- At least 7 years of hands-on aseptic fill-finish experience for the Senior Scientist level, or 10 years for the Principal Scientist level, in a GMP environment.
- In-depth knowledge of aseptic processing techniques, sterilization methods, and container-closure systems.
- Familiarity with US and EU regulatory requirements and guidelines for aseptic processing and sterile drug products.
- Strong analytical and troubleshooting abilities to address complex manufacturing challenges.
- Excellent written and verbal communication skills, including the ability to prepare detailed technical documents and interact effectively with cross-functional teams.
- Proven ability to lead projects and mentor junior staff while promoting a collaborative, compliant work environment.
Nice To Haves
- Experience with sterile single-use technologies, fill-finish isolator systems, and restricted access barrier systems (RABS).
- Proven success leading process validation, gas cycle development and validation, and validation of aseptic processing and sterilization (media fills).
- Prior involvement in regulatory inspections and audit readiness.
Responsibilities
- Lead the development, optimization, and scale-up of aseptic fill-finish processes, including vial filling, stopper/capping, and visual inspection.
- Ensure processes comply with FDA, EMA, ICH, and USP guidelines and cGMP standards.
- Oversee process transfer from development to commercial manufacturing, maintaining process integrity and enabling smooth transitions.
- Address complex manufacturing issues and implement corrective actions and process improvements.
- Prepare and review technical documents, including batch records, SOPs, validation protocols, and regulatory submissions.
- Work with Quality Assurance, Quality Control, Engineering, and Regulatory Affairs to support cohesive, compliant operations.
- Guide and mentor junior scientists and technicians, fostering continuous learning and improvement.
Benefits
- Hands-on experience in a growing pharmaceutical business.
- Exposure to various functions.
- Opportunities for career development.
- Collaborative and supportive work environment.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
