Purpose of Position:
- To serve as a liaison between the manufacturing team and the project management team to assure all manufacturing related activities and expectations are communicated to the direct manufacturing team.
- Act as the manufacturing representative on cross functional projects teams and communicate the relevant information required to successfully execute a manufacturing campaign
Key Responsibilities:
Originate, revise, approve, and/or review GMP documentation including but not limited to:
-Process Instructions,SOP's, Change Controls and Planned Deviations
- Complete tasks in Oracle system (including generation of product item numbers / entering raw materials required for a campaign etc)
- Review project specific documents including but not limited to:
-Manufacturing Process Outline (MPO)
- Manufacturing Process Formula (MPF)
-Project Change Controls
-Work Orders
-Project Representation
- Represent Manufacturing on Project Teams, communicating and delivering project expectations.
- Attend daily/ weekly internal and external customer meetings to report manufacturing updates.
- Keep detailed records of project campaigns
- Assist in technical and safety risk assessment and the communicate any risks to the manufacturing team.
- Assist in project specific compliance investigations.
- Interact with various functional groups and the customer to accomplish project goal
- Work with the project managers and customers to resolve Manufacturing specific questions and Process Instruction comments
Job Knowledge Required:
- This is specialist position requiring a comprehensive knowledge of the cGMP requirements for pharmaceutical manufacturing or API manufacturing
- Minimum education requirements include a science related Bachelor’s degree or equivalent work experience.
- Knowledge of biotechnology / chemical manufacturing processes and equipment is preferred
Equal Opportunity Employer