Responsibilities
- Manage and lead all aspects of a manufacturing production area/section in an Inspection and Packaging facility; maintain production in full cGMP compliance.
- Supervise, hire, and develop staff; ensure production schedules are completed.
- Compliance: evaluate/approve reports and protocols; ensure cGMP and CFR compliance; revise/update/review procedures; coordinate development/revision of SOPs; evaluate manufacturing procedures and recommend optimizations; follow corporate change control and notify Regulatory/QA; interact with the FDA; ensure Amgen policies are followed.
- Process/Equipment/Facilities: ensure maintenance and revalidation; collaborate with QA/QC, PPIC, Clinical Mfg, PD, Regulatory, etc.; develop/implement solutions and resolve operational problems; coordinate setup of critical new manufacturing processes.
- Staff supervision: selection, training, evaluation, staff relations, development; maintain training programs; schedule production/maintenance; audit/evaluate for plant safety.
- Administrative: plan/develop/maintain budget; support department goals.
- Shift: rotating 12-hour schedule cycling every two weeks (3 days one week, 4 days the next).
Qualifications
- Doctorate; or Master’s + 3 years; or Bachelor’s + 5 years; or Associate’s + 10 years; or HS Diploma/GED + 12 years in pharmaceutical/medical device/biotech.
- Experience managing people and/or leading teams/projects/programs or directing allocation/resources.
Preferred
- Science/Engineering/Business Administration background; overnight shift availability; strong managerial skills; Non-Conformance and CAPA (incl. triage within established goal); leadership/team building; verbal/written (technical writing) communication; conflict resolution; analytical problem solving; project management; coaching/mentoring/counseling; flexibility/change management; regulatory requirements; scheduling; presentation skills.