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.
Requirement:
Bachelor's degree in Pharmaceutical Sciences, Chemical Engineering, Biological Sciences, or a related field Master's or MBA is an advantage.
At least 10 years of experience in drug product manufacturing, including aseptic processing and lyophilization equipment and processes.
Minimum 3 years of people management experience.
Hands-on experience in aseptic qualification (e.g., media fill) and operations such as decontamination, sterilization, aseptic filling, and lyophilization.
Experience in a CDMO environment is preferred.
Strong interpersonal skills with the ability to engage effectively with clients.
