Operations Support Team Lead, Drug Product Operations

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.).
• 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.

Education

• Bachelor's degree in Pharmaceutical Sciences, Chemical Engineering, Biological Sciences or related field.
• Master's degree or MBA is a plus.

Experience

• 8+ years in drug product manufacturing, with experience in aseptic processing and operational support
• 3+ years of people management experience

Skills

• 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.