Manager Manufacturing (12hr shift)
Amgen
5 hours ago
On-site
New Albany, OH
Operations
Manufacturing Manager
Responsibilities
- Manage and lead all aspects of a small manufacturing production area or a section of a larger Packaging manufacturing area; maintain production in full cGMP compliance.
- Supervise, hire, and develop staff; ensure production schedules are completed in a shift.
- Evaluate and approve reports and protocols.
- Ensure cGMP and CFR compliance of operating areas.
- Revise, update, and review procedures; manage development and revision of SOPs.
- Evaluate current operating procedures and recommend changes to optimize production.
- Ensure corporate change control procedures are followed; notify Regulatory and QA prior to changes.
- Interact with the FDA and ensure Amgen policies are followed.
- Ensure maintenance and revalidation of systems.
- Collaborate with cross-functional teams (e.g., QA/QC, PPIC, Clinical Mfg, PD, Regulatory) to complete production activities.
- Develop, implement, and assess solutions for problems; resolve problems during operation.
- Coordinate set up of critical new manufacturing processes.
- Responsible for staff selection, training, evaluation, staff relations, and development; ensure training programs are maintained.
- Ensure scheduling of production and maintenance activities; assist management with organizational structure and responsibilities.
- Ensure plant safety through auditing and evaluations.
- Assist with planning, developing, and maintaining budget; develop and maintain department goals.
Qualifications
Basic Qualifications (meet at least one)
- Doctorate degree
- Or Master’s degree + 3 years’ experience in pharmaceutical/medical device/biotechnology
- Or Bachelor’s degree + 5 years’ experience in pharmaceutical/medical device/biotechnology
- Or Associate’s degree + 10 years’ experience in pharmaceutical/medical device/biotechnology
- Or High school diploma/GED + 12 years’ experience in pharmaceutical/medical device/biotechnology
- In addition: experience directly managing people and/or leadership experience leading teams/projects/programs or directing allocation/resources (managerial experience may run concurrently with technical experience).
Preferred Qualifications
- Educational background in Science, Engineering, or Business Administration
- Availability to work a 12-hour PM shift
- Strong managerial skills
- Non-Conformance and CAPA; triage non-conformances within established goals
- Leadership and team building
- Verbal and written communication (including technical writing)
- Conflict resolution, analytical problem solving, project management
- Coaching/mentoring/counseling
- Ability to be flexible and manage change
- Regulatory requirements
- Scheduling
- Presentation skills
Benefits
- Total Rewards Plan (eligibility-based): retirement and savings plan; group medical/dental/vision; life and disability insurance; flexible spending accounts; discretionary annual bonus (or sales incentive for field sales); stock-based long-term incentives; time-off plans; flexible work models (remote/hybrid where possible).
Application Instructions
- Apply at careers.amgen.com.
Responsibilities
- Manage and lead all aspects of a small manufacturing production area or a section of a larger Packaging manufacturing area; maintain production in full cGMP compliance.
- Supervise, hire, and develop staff; ensure production schedules are completed in a shift.
- Evaluate and approve reports and protocols.
- Ensure cGMP and CFR compliance of operating areas.
- Revise, update, and review procedures; manage development and revision of SOPs.
- Evaluate current operating procedures and recommend changes to optimize production.
- Ensure corporate change control procedures are followed; notify Regulatory and QA prior to changes.
- Interact with the FDA and ensure Amgen policies are followed.
- Ensure maintenance and revalidation of systems.
- Collaborate with cross-functional teams (e.g., QA/QC, PPIC, Clinical Mfg, PD, Regulatory) to complete production activities.
- Develop, implement, and assess solutions for problems; resolve problems during operation.
- Coordinate set up of critical new manufacturing processes.
- Responsible for staff selection, training, evaluation, staff relations, and development; ensure training programs are maintained.
- Ensure scheduling of production and maintenance activities; assist management with organizational structure and responsibilities.
- Ensure plant safety through auditing and evaluations.
- Assist with planning, developing, and maintaining budget; develop and maintain department goals.
Qualifications
Basic Qualifications (meet at least one)
- Doctorate degree
- Or Master’s degree + 3 years’ experience in pharmaceutical/medical device/biotechnology
- Or Bachelor’s degree + 5 years’ experience in pharmaceutical/medical device/biotechnology
- Or Associate’s degree + 10 years’ experience in pharmaceutical/medical device/biotechnology
- Or High school diploma/GED + 12 years’ experience in pharmaceutical/medical device/biotechnology
- In addition: experience directly managing people and/or leadership experience leading teams/projects/programs or directing allocation/resources (managerial experience may run concurrently with technical experience).
Preferred Qualifications
- Educational background in Science, Engineering, or Business Administration
- Availability to work a 12-hour PM shift
- Strong managerial skills
- Non-Conformance and CAPA; triage non-conformances within established goals
- Leadership and team building
- Verbal and written communication (including technical writing)
- Conflict resolution, analytical problem solving, project management
- Coaching/mentoring/counseling
- Ability to be flexible and manage change
- Regulatory requirements
- Scheduling
- Presentation skills
Benefits
- Total Rewards Plan (eligibility-based): retirement and savings plan; group medical/dental/vision; life and disability insurance; flexible spending accounts; discretionary annual bonus (or sales incentive for field sales); stock-based long-term incentives; time-off plans; flexible work models (remote/hybrid where possible).
Application Instructions
- Apply at careers.amgen.com.