Summary
The Operations Support Team Lead 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 Lead of Commercial DP, this position will serve as an Operations Support in reparation for aseptic manufacturing operations readiness (e.g., service contract, training program, SOP/MBR/WI and documentation generation, logbook, environmental and utilities sampling, etc.). The Operations Support Team Lead will be responsible for building and leading high-performing team to ensure efficient and compliant execution of critical process steps. 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).
Job 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 (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.
- 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 necessary and be available for extended periods for overseas training.
- Maintain compliance with training requirements for self and staffs at all times.
Qualification
- Bachelor's degree in Pharmaceutical Sciences, Chemical Engineering, Biological Sciences or related field.
- Master's degree or MBA is a plus.
- 8+ years in drug product manufacturing, with experience in aseptic processing and operational support
- 3+ years of people management experience
- Direct experience in drug product manufacturing such as part preps, formulation, sterilization, and any drug product manufacturing process.
- Experience in a fast-paced CDMO (Contract Development and Manufacturing Organization) environment is desirable.
- Strong interpersonal skills and ability to interact with clients effectively.
