Senior Scientist / Principal Scientist, Aseptic Fill Finish Operations

Position Summary

Transpire Bio Inc., a clinical‑stage biopharmaceutical company specializing in inhalation formulation and delivery platforms, is seeking a highly skilled and experienced Senior Scientist / Principal Scientist to lead and manage 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.

Essential Duties and Responsibilities

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

Required Qualifications

• Advanced degree (MS or PhD) in Pharmaceutical Sciences, Chemical Engineering, Biotechnology, or a related field.
• 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.
• In‑depth knowledge of aseptic processing techniques, sterilization methods, and container‑closure systems.
• Familiarity with global regulatory requirements (US, EU) and guidelines pertaining to aseptic processing and sterile drug products.
• Strong analytical and troubleshooting abilities to address complex manufacturing challenges.
• Excellent written and verbal communication skills, with the ability to prepare detailed technical documents and interact effectively with cross‑functional teams.
• Proven ability to lead projects and mentor junior staff, promoting a collaborative and compliant work environment.

Preferred Qualifications

• Experience with Sterile single use technologies, Fill-Finish isolator systems, and restricted access barrier systems (RABS).
• Proven success of 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.

Why Join Us?

We are a fast-growing pharmaceutical startup dedicated to innovation and improving patient outcomes. Join us to gain hands-on experience in a growing pharmaceutical business, get exposure to various functions with opportunities for career development and work in a collaborative and supportive work environment.