The Operations Support Senior Manager will play a critical role in supporting the startup of a state-of-the-art aseptic manufacturing facility with multiple production lines. Reporting to the Department Head of Commercial DP, this position will serve as Operations Support in preparation for aseptic manufacturing operations readiness (e.g., service contract, training program, SOP/MBR/WI and documentation generation, logbook, environmental and utilities sampling, etc.).
You will be responsible for building and leading high-performing team to ensure efficient and compliant execution of critical tasks. Additional responsibility may be required during the initial site startup, while maintaining strict adherence to regulatory standards. Additionally, the Team Lead will interface with clients and oversee the fast-paced and crucial stage of New Product Introduction (NPI) for multiple new products, ensuring successful technology transfer and process validation, followed by support for the product approval process (e.g., mock-up and prior approval inspections).
Note: Shuttles to the site are available at selected MRT stations.
Role & Responsibilities
- Support the installation and qualification of new manufacturing equipment as required from Operational Support related roles.
- Develop and implement operational procedures, including SOPs, master batch records, and work instructions, as required
- Establish service provider, manage contractors and schedules with contractors (e.g., cleaning/disinfecting, gown laundry, etc.).
- Develop utilities and environmental sampling schedule per procedure and manage the sampling program.
- Hire, train, and manage operational staffs required to support site readiness.
- Develop, manage, and track training and qualification of manufacturing operation staffs.
- Coordinate and train as required before systems go-live.
- Ensure adherence to quality standards and client requirements for aseptic processes as required during the initial site startup.
- Work with Manufacturing Science & Technology (MSAT), Validation, Quality, and QC teams to ensure applicable procedures are developed and personnel are trained for new product introductions.
- Stay informed on global regulatory requirements (such as FDA, EMA, PIC/S, ICH) for aseptic manufacturing and product introduction, and remain up to date on current Good Manufacturing Practices (cGMP).
- Demonstrate mastery of Quality Management System (QMS) production support systems such as Change Control, Deviation, CAPA, and SAP.
- Conduct and manage investigations using tools such as 5 Whys and Fishbone/Ishikawa analysis, including performing product impact assessments and ensuring closure within tight timelines.
- Interface with clients for technology transfer, new product introduction (NPI) projects, as required.
- Be accountable for the Operational Support responsibilities and ensure adherence to stringent requirements.
- Some travel as needed and be available for extended periods for overseas training if needed.
- Maintain compliance with training requirements for self and staffs at all times.
Requirement:
- Bachelor's degree/Master Degree in Pharmaceutical Sciences, Chemical Engineering, Biological Sciences or related field.
- 10 years and above experience in drug product manufacturing, with experience in aseptic processing and operational support with 3 years of people management experience
- Direct experience in drug product manufacturing such as part preps, formulation, sterilization, and any drug product manufacturing process.
- Strong interpersonal skills and ability to interact with clients effectively.
- Direct experience with client and regulatory audits is a plus.
- Experience working in multicultural and multinational environments is preferred.
