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.

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