Manager Manufacturing (12hr shift)

Role Summary

Manager Manufacturing (12hr shift) at Amgen. Responsible for managing and leading all aspects of a small manufacturing production area or a section of a larger production area in a Packaging facility, ensuring full cGMP compliance, supervising and developing staff, and meeting production schedules.

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 made aware prior to the changes.
• Interact with the FDA.
• Ensure Amgen policies are followed.
• Ensure maintenance and revalidation of systems.
• Collaborate with cross-functional teams in completing production activities.
• Develop, implement and assess solutions for problems; resolve problems during operation.
• Coordinate setup of critical new manufacturing processes.
• Responsible for selection, training, evaluation, staff relations and development of staff.
• Ensure training programs are maintained; schedule production and maintenance activities.
• Interface with management to optimize organizational structure and responsibilities; ensure plant safety through auditing and evaluations.
• Plan, develop, and maintain department budgets; assist in developing department goals.

Qualifications

• Basic Qualifications:
  • Doctorate degree
  • Or Master’s degree and 3 years of experience in the pharmaceutical, medical device or biotechnology industry
  • Or Bachelor’s degree and 5 years of experience in the pharmaceutical, medical device or biotechnology industry
  • Or Associate’s degree and 10 years of experience in the pharmaceutical, medical device or biotechnology industry
  • Or High school diploma / GED and 12 years of experience in the pharmaceutical, medical device or biotechnology industry
• In addition to meeting at least one of the above requirements, experience directly managing people and/or leadership experience leading teams, projects, programs, or directing allocation of resources.

Preferred Qualifications

• Educational background in Science, Engineering or Business Administration
• Availability to work on a 12-hour PM shift
• Strong managerial skills
• Non-Conformance and CAPA
• Leadership and team building
• Verbal and written communication, including technical writing skills
• Conflict resolution
• Analytical problem solving
• Project management
• Coaching, mentoring and counseling
• Ability to be flexible and manage change
• Regulatory requirements; scheduling; presentation skills

Skills

• cGMP compliance knowledge
• Process and equipment management
• Cross-functional collaboration
• Problem solving and troubleshooting
• Leadership and staff development
• Budget planning and administrative acumen

Education

• As detailed in Basic Qualifications and Preferred Qualifications above

Additional Requirements

• Availability to work a 12-hour PM shift