Job Description

About the Role

Join a Singapore-based biopharmaceutical company supporting the development and manufacture of biologic medicines for global markets. The Aseptic Filling Team Lead (PFS) will play a pivotal role in starting 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.

You will lead the PFS filling team through equipment readiness, procedure development, validation and batch execution. Working closely with internal functions and clients, you will support technology transfer and the introduction of multiple new products, through process validation and product approval activities, including mock-up and Prior Approval Inspections.

Key Responsibilities

  1. Support installation, commissioning and qualification of new manufacturing equipment, and own or oversee assigned equipment packages.
  2. Develop, review and implement operational documentation, including SOPs, master batch records and work instructions.
  3. Recruit, train and manage manufacturing supervisors and staff to support validation activities and routine batch execution.
  4. Lead compliant aseptic operations, including isolator preparation, cleaning and decontamination, sterilization, aseptic filling and plunger stoppering.
  5. Own the specified cleanroom environment and ensure that personnel, processes and facilities consistently meet stringent requirements.
  6. Partner with Engineering and Maintenance to coordinate timely calibration, maintenance and validation of production equipment and supporting utilities.
  7. Work with MSAT, Validation, Quality and QC to develop procedures, prepare personnel and deliver successful new product introductions.
  8. Interface with clients on technology transfer, NPI projects and process validation, providing clear and effective operational communication.
  9. Support product approval readiness, including mock-up activities and Prior Approval Inspections.
  10. Maintain strong working knowledge of applicable cGMP and global regulatory expectations, including FDA, EMA, PIC/S and ICH requirements for aseptic manufacturing.
  11. Use and support production quality systems, including Change Control, Deviation, CAPA and SAP processes.
  12. Ensure personal and team training remains current and complete at all times.
  13. Provide flexible operational oversight during off-hours when required, and travel for project oversight, site visits or extended overseas training.

Job Requirements

Qualifications and Experience

  1. Bachelor’s degree in Pharmaceutical Sciences, Chemical Engineering, Biological Sciences or a related discipline.
  2. At least 12 years of experience in drug product manufacturing, including hands-on experience in aseptic processing.
  3. At least 3 years of people-management experience, ideally leading manufacturing supervisors and frontline teams.
  4. Direct experience with aseptic qualification activities, such as media fill simulations, and drug product manufacturing processes including decontamination, sterilization, aseptic filling and plunger stoppering.
  5. Experience supporting equipment and facility readiness, qualification, validation, technology transfer or new product introduction is highly relevant.
  6. Experience in a fast-paced CDMO (Contract Development and Manufacturing Organization) environment is desirable.
  7. A Master’s degree or MBA is an advantage.

Skills and Attributes

  1. Strong understanding of cGMP and regulatory expectations for aseptic manufacturing and commercial drug product operations.
  2. Ability to develop practical, clear operational procedures and maintain robust documentation and quality-system practices.
  3. Effective team leadership skills, with the ability to hire, coach and develop supervisors and manufacturing staff.
  4. Strong interpersonal and communication skills, including the ability to collaborate across functions and interact effectively with clients.
  5. Organized and solutions-focused, with the ability to manage priorities in a fast-paced start-up and production environment.
  6. Willingness to support off-hours operational execution, travel when required and undertake extended overseas training.