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.
