The Manufacturing Manager- Upstream is responsible for overseeing the manufacturing of upstream microbial culture to harvest process and intermediates while complying with cGMP and GDP. The Manufacturing Manager will schedule a manufacturing plan and manage manufacturing personnel performing the upstream operations. The Manufacturing Manager is expected to obtain a strong understanding of the manufacturing process and equipment, and other site quality systems. The Manufacturing Manager is expected to act a mentor for all manufacturing associates and manufacturing supervisor, perform performance reviews, and lead manufacturing meetings and audits.
ROLE RESPONSIBILITIES
Manage and support the manufacturing of upstream microbial (E. coli) culture and intermediates.
Comply with cGMP and GDP regulations.
Obtain a strong understanding of the manufacturing process and equipment operation.
Coordinate interdepartmentally with Quality Control, Facilities, MSATs, and Quality Assurance for scheduling and execution of multiple activities including, but not limited to, sample submission, administrative paperwork, protocol execution, deviation investigation, and calibration/maintenance.
Communicate with vendors regarding raw materials or services.
Perform inventory cycle counts and site fit-for-use inspections.
Perform revision and creation of SOP's, batch records, or associated protocols under a change control program.
Perform final review of batch records, deviations, and change controls.
Perform deviation initiation, investigation, resolution, and CAPA.
Perform performance reviews.
Organize and lead manufacturing team meetings.
Order raw materials and equipment.
Represent the manufacturing department during an internal or external audit.
Screen and interview manufacturing applicants.
Train manufacturing managers with similar role responsibilities.
SKILLS
Performs tasks while maintaining cGMP compliance.
Ability to perform responsibilities without supervision.
Proficiency of Microsoft Windows, Word, Excel, Teams, or other organizational applications.
Good written, verbal, and communication skills.
Ability to communicate interdepartmentally with Quality Control, Facilities, MSATs, and Quality Assurance for manufacturing related projects.
The Manufacturing Manager- Upstream must develop the skills necessary to perform required responsibilities in order to achieve company objectives and goals. The Manufacturing Manager- upstream must have strong record keeping, organizational, written, and verbal communication skills to collaborate with manufacturing personnel, and interdepartmentally, to enable coordination/scheduling of manufacturing related projects and act as a lead of the manufacturing department. The Manufacturing Manager candidate is desired to have previous experience performing cGMP manufacturing and/or managing.
QUALIFICATIONS
At a minimum, a B.A/B.S., or M.S. in a biological science or engineering field with a minimum of 5 years of relevant work experience, or a combination of education and experience.