Vial Aseptic Filling Team Lead (Senior Manager), Drug Product Operations

About the role

The Vial Aseptic Filling Team Lead (Senior Manager) will help start up a state-of-the-art aseptic manufacturing facility with multiple production lines. Reporting to the Department Head of Commercial DP, the role is the operational end-user and main point of contact for the vial filling area, covering equipment, facilities, supporting systems and utilities. The leader builds and leads manufacturing teams and oversees safe, efficient, compliant day-to-day operations, with a focus on isolator preparation, cleaning and decontamination, aseptic filling, stoppering, lyophilization and capping, as well as operational readiness, NPI, technology transfer and process validation.

Key responsibilities

• Support installation, commissioning and qualification of new equipment and own or oversee key equipment packages for the vial filling area.
• Develop, review and implement operational documentation such as SOPs, master batch records and work instructions.
• Recruit, train, coach and manage manufacturing personnel, including supervisors, to support validation and routine batch execution.
• Lead compliant execution of aseptic operations, including part washing and packaging, sterilization, isolator preparation and decontamination, filling, stoppering, lyophilization and capping.
• Ensure the manufacturing area and cleanroom meet quality, safety, client and regulatory requirements.
• Coordinate with Engineering and Maintenance on calibration, maintenance and validation of equipment and systems.
• Work with MSAT, Validation, Quality and QC on procedures, NPI, technology transfer and process validation, and interface with clients on these topics.
• Maintain knowledge of cGMP and regulatory expectations (FDA, EMA, PIC/S, ICH).
• Use QMS processes such as Change Control, Deviation, CAPA and SAP transactions.
• Provide off-hours oversight when needed, travel for projects and site visits, and be available for extended overseas training.

Required profile

• Bachelor's degree in Pharmaceutical Sciences, Chemical Engineering, Biological Sciences or a related discipline.
• At least 12 years of drug product manufacturing experience, including hands-on aseptic processing.
• At least 3 years of people-management experience, ideally leading manufacturing teams in a regulated environment.
• Experience with equipment installation, qualification, operational readiness, process validation or product introduction; CDMO experience is desirable.
• Fluent written and spoken English; comfort in multicultural, multinational settings is preferred.

Required skills

• Aseptic manufacturing principles, cGMP, cleanroom practices and regulatory expectations.
• Production QMS processes (Change Control, Deviation, CAPA); familiarity with SAP is expected.
• Leadership, communication and client-facing skills; audit experience is an advantage.