Support the installation and qualification of the new manufacturing equipment and own/oversee key equipment packages
Develop and implement operational procedures (SOPs, master batch records, work instructions).
Hire, train, and manage manufacturing staff to support validation and batch execution.
Ensure adherence to quality standards and client requirements for aseptic processes such as cleaning and decontamination, sterilization, aseptic filling, and plunger stoppering.
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 stay up to date on CGMP.
Master in QMS production support systems such Change Control, Deviation, CAPA, and SAP.
Accountable for the specified cleanroom environment area and ensure adherence to stringent requirements, with flexibility for overseeing executions during off-hours, if needed.
Travel as necessary for project oversight, site visits, and training.
Be available for extended period for training overseas.
Interface with clients for technology transfer/NPI projects and process validation
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.
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 plunger stoppering.
Experience in a fast-paced CDMO (Contract Development and Manufacturing Organization) environment is desirable.
Strong interpersonal skills and ability to interact with clients effectively.
