Overview

This role will play a critical role in supporting the startup of a state-of-the-art aseptic manufacturing facility with multiple production lines. Reporting to the Department Lead of Commercial DP, this position will serve as an end-user and point of contact for the Parts Preparation area, including its equipment (part washer and autoclaves), facility, supporting systems, and utilities, in preparation for aseptic manufacturing operations.

Responsibilities include developing and owning standard operating procedures (SOPs). You will be responsible for building and leading high-performing teams of supervisors to ensure efficient and compliant execution of critical process steps. These include equipment washing, packing, and sterilization in preparation for aseptic filling, and other process steps as required during the initial site startup, while maintaining strict adherence to regulatory standards. Additionally, this role Lead will interface with clients and oversee the fast-paced and crucial stage of New Product Introduction (NPI) for multiple new products, ensuring successful technology transfer and process validation, followed by support for the product approval process (e.g., mock-up and prior approval inspections).

Note: Shuttles to the site are available from major MRT stations, including those in the East Coast and Central areas.

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 manufacturing staff to support validation activities and batch execution.
Ensure adherence to quality standards and client requirements for aseptic processes such as part washing/packaging, sterilization 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.
Be accountable for the specified cleanroom environment and ensure adherence to stringent requirements, with flexibility to oversee execution during off-hours, if needed.
Travel as necessary for project oversight, site visits, and training.
Be available for extended periods for overseas training.
Interface with clients for technology transfer, new product introduction (NPI) projects, and process validation.

Requirement

Bachelor's degree in Pharmaceutical Sciences, Chemical Engineering, Biological Sciences or related field.
8 - 10 years in drug product manufacturing, with experience in aseptic processing.
3 - 5 years of people management experience
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.

Manufacturing Manager/Senior Manager, Parts Preparation Drug Product Operations