Manager Manufacturing (12hr shift)

Role Summary

Manager Manufacturing (12hr shift) at Amgen. Manage and lead all aspects of a small manufacturing production area or a section of a larger production area in a Packaging facility, ensuring production runs in full cGMP compliance. Supervises, hires, and develops staff and ensures production schedules are completed within a shift.

Responsibilities

• Evaluate and approve reports and protocols.
• Ensure cGMP and CFR compliance of operating areas.
• Revise, update, and review procedures.
• Manage the development and revision of SOPs.
• Evaluate current operating procedures and recommend changes to optimize production.
• Assure all corporate change control procedures are followed, and Regulatory and QA are informed prior to changes.
• Interact with the FDA.
• Ensure Amgen policies are followed.
• Ensure maintenance and re-validation of systems.
• Collaborate with cross-functional teams to complete production activities.
• Develop, implement and assess solutions for problems; resolve issues during operation.
• Coordinate setup of critical new manufacturing processes.
• Staff supervision: selection, training, evaluation, staff relations and development; maintain training programs; schedule production and maintenance activities; optimize organizational structure; ensure plant safety through auditing and evaluations.
• Interacts with management in planning, developing and maintaining budget; assist in developing department goals.

Qualifications

• Required: Doctorate degree; or Master‚Äôs degree and 3 years of relevant experience; or Bachelor‚Äôs degree and 5 years; or Associate‚Äôs degree and 10 years; or High school diploma/GED and 12 years in pharmaceutical/medical device/biotechnology industry. Must have direct management/leadership experience.
• Preferred: Educational background in Science, Engineering or Business Administration; availability to work a 12-hour PM shift; strong managerial, leadership, communication, problem solving, and project management skills; experience with Non-Conformance and CAPA; regulatory requirements knowledge; scheduling and presentation skills.

Skills

• Leadership and team building
• Verbal and written communication, including technical writing
• Conflict resolution
• Analytical problem solving
• Project management
• Coaching, mentoring and counseling
• Ability to manage change and be flexible
• Regulatory knowledge and scheduling
• Presentation skills

Education

• See Qualifications above for degree requirements.

Additional Requirements

• Availability to work on a 12-hour PM shift (preferred).
• Compliance with regulatory and safety expectations; ability to interact with FDA as needed.