Transpire Bio
Senior Scientist / Principal Scientist, Aseptic Fill‑Finish Operations
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.
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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.
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