Aseptic Filling Team Lead (PFS), Drug Product Operations

About the role

A Singapore-based biopharmaceutical company supporting the development and manufacture of biologic medicines for global markets is looking for an Aseptic Filling Team Lead (PFS) to start up a state-of-the-art, greenfield aseptic manufacturing facility with multiple production lines. As the end-user and key point of contact for the prefilled syringe (PFS) filling area, equipment, facility and supporting utilities, you will help prepare the operation for commercial manufacturing, build and lead high-performing teams, and ensure safe, efficient and compliant execution of aseptic processes.

Key responsibilities

• Lead the PFS filling team through equipment readiness, procedure development, validation and batch execution.
• Support installation, commissioning and qualification of new manufacturing equipment, and own or oversee assigned equipment packages.
• Develop, review and implement operational documentation, including SOPs, master batch records and work instructions.
• Recruit, train and manage manufacturing supervisors and staff to support validation activities and routine batch execution.
• Lead compliant aseptic operations, including isolator preparation, cleaning and decontamination, sterilization, aseptic filling and plunger stoppering.
• Own the specified cleanroom environment and ensure personnel, processes and facilities meet stringent requirements.
• Partner with Engineering and Maintenance on calibration, maintenance and validation of equipment and utilities.
• Work with MSAT, Validation, Quality and QC on procedures, personnel preparation and new product introductions, including mock-ups and Prior Approval Inspections.
• Interface with clients on technology transfer, NPI projects and process validation, and support product approval readiness.
• Maintain working knowledge of cGMP and regulatory expectations (FDA, EMA, PIC/S, ICH) and use quality systems such as Change Control, Deviation, CAPA and SAP.
• Keep team training current, provide flexible off-hours oversight when needed, and travel for project oversight, site visits or overseas training.

Required profile

• Bachelor's degree in Pharmaceutical Sciences, Chemical Engineering, Biological Sciences or a related discipline; a Master's degree or MBA is an advantage.
• At least 12 years of experience in drug product manufacturing, including hands-on aseptic processing.
• At least 3 years of people-management experience, ideally leading manufacturing supervisors and frontline teams.
• Direct experience with aseptic qualification activities such as media fill simulations, and with decontamination, sterilization, aseptic filling and plunger stoppering.
• Experience supporting equipment and facility readiness, qualification, validation, technology transfer or new product introduction is highly relevant; CDMO experience is desirable.

Required skills

• Strong understanding of cGMP and regulatory expectations for aseptic manufacturing.
• Ability to develop clear operational procedures and maintain robust documentation and quality-system practices.
• Team leadership, hiring, coaching and developing supervisors and staff.
• Strong interpersonal and communication skills, collaboration across functions and with clients.
• Ability to manage priorities in a fast-paced start-up and production environment.