Job Description:
We are seeking a seasoned manufacturing professional to lead our strategic planning processes. The ideal candidate will have extensive experience in cGMP biological manufacturing and a proven track record of successfully managing functional and project teams.
The role involves establishing clear team identity, roles, responsibilities, and hand-over with other functions. This includes serving as a subject matter expert for MFG 7 drug substance process, providing technical oversight to teams, coaching associate staff, and collaborating closely with QC & QA groups to ensure GMP compliance.
Key Responsibilities include:
* Serving as a subject matter expert for MFG 7 drug substance process
* Providing technical oversight to teams and coaching associate staff
* Collaborating closely with QC & QA groups to ensure GMP compliance
Requirements:
* Minimum 15 years experience in cGMP biological manufacturing environment
* Previous experience managing and/or leading functional and project teams
* Experience across both Upstream and Downstream manufacturing activities
Preferred Qualifications:
* Masters level qualifications
* Greenfield or large site expansion experience
* Experience working with lean principals and implementing CI processes