Senior Scientist​/Principal Scientist, Aseptic Fill Finish Operations

Position: Senior Scientist / Principal Scientist, Aseptic Fill Finish Operations
Job Summary

Transpire Bio Inc. (TBI), a revenue generating clinical-stage biopharmaceutical company specializing in development and commercialization of orally inhaled and nasal drug products (OINDPs). TBI is seeking a highly skilled and experienced Senior Scientist / Principal Scientist to lead, manage and execute aseptic fill-finish operations for sterile drug products. The ideal candidate will have 7-10 years of hands-on experience in aseptic processing within a GMP environment, with a strong background in process development, scale-up, and technology transfer.

This role requires a deep understanding of aseptic techniques, regulatory compliance, and a commitment to ensuring the highest standards of product quality and sterility assurance.

Key Responsibilities

• Process Leadership: Lead the development, optimization, and scale-up of aseptic fill-finish processes, including vial filling, stopper/capping, and visual inspection.
• Regulatory Compliance: Ensure all processes comply with FDA, EMA, ICH, and USP guidelines, maintaining strict adherence to cGMP standards.
• Technology Transfer: Oversee the transfer of processes from development to commercial manufacturing, ensuring smooth transitions and maintaining process integrity.
• Troubleshooting & Optimization: Address and resolve complex manufacturing issues, implementing corrective actions and process improvements as necessary.
• Documentation & Reporting: Prepare and review technical documents, including batch records, SOPs, validation protocols, and regulatory submissions.
• Cross-Functional Collaboration: Work closely with Quality Assurance, Quality Control, Operations, and Regulatory Affairs to ensure cohesive and compliant operations.
• Mentorship: Provide guidance and mentorship to junior scientists and technicians, fostering a culture of continuous learning and improvement.

Qualifications

• Education: Advanced degree (MS or PhD) in Pharmaceutical Sciences, Chemical Engineering, Biotechnology, or a related field.
• Experience: A minimum of 7 years (Senior Scientist) to 10 years (Principal Scientist) of hands-on experience in aseptic fill-finish operations within a GMP environment.
• Technical Expertise: In-depth knowledge of aseptic processing techniques, sterilization methods, and container-closure systems.
• Regulatory Knowledge: Familiarity with global regulatory requirements and guidelines pertaining to aseptic processing and sterile drug products.
• Problem-Solving Skills: Strong analytical and troubleshooting abilities to address complex manufacturing challenges.
• Communication: Excellent written and verbal communication skills, with the ability to prepare detailed technical documents and interact effectively with cross-functional teams.
• Leadership: Proven ability to lead projects and mentor junior staff, promoting a collaborative and compliant work environment.

Preferred Qualifications

• Experience with single-use technologies, isolator systems, and restricted access barrier systems (RABS).
• Knowledge of process validation, gas cycle development and validation, and media fills.
• Familiarity with Annex 1 requirements for aseptic process simulation (APS).
• Prior involvement in regulatory inspections and audit readiness.