Lyophilization Team Lead, Drug Product Operations

Role & Responsibilities

• Support the installation and qualification of new manufacturing equipment, and own/oversee key equipment packages.
• Develop and implement operational procedures, including SOPs, master batch records, and work instructions.
• Hire, train, and manage staffs to support validation activities and batch execution.
• Ensure adherence to quality standards and client requirements for aseptic processes, particularly in lyophilization and other processing steps as required during the initial site startup.
• Collaborate with Engineering and Maintenance to ensure timely calibration and validation of production equipment.
• Work with Manufacturing Science & Technology (MSAT), Validation, Quality, and QC teams to ensure 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, and process validation.
• Be accountable for the specified cleanroom environment and ensure adherence to stringent requirements.
• Be flexible to oversee execution during off-hours, if needed.
• Travel as necessary for project oversight, site visits, 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

• 10+ years in drug product manufacturing, with experience in aseptic processing and lyophilization related equipment and process.
• 3+ years of people management experience

Skills

• Direct experience in aseptic qualification (e.g., media fill simulations) and drug product manufacturing such as decontamination, sterilization, aseptic filling, and lyophilization.
• Experience in a fast-paced CDMO (Contract Development and Manufacturing Organization) environment is desirable.
• Strong interpersonal skills and ability to interact with clients effectively.