Career Category

Job Description

Join Amgen's Mission to Serve Patients

At Amgen, our shared mission to serve patients living with serious illnesses drives everything we do. Every team member plays an important role in helping advance science and deliver medicines that make a meaningful difference for patients around the world.

Amgen fights the world's toughest diseases by harnessing the best of biology and technology. We draw on our scientific expertise to push beyond what is known today and help people live longer, fuller lives.

If you are energized by collaboration, continuous learning, and meaningful work, we invite you to join our team and help make an impact.

Manager Manufacturing I

What you will do

Let’s do this. Let’s change the world. This position is the on-shift front line manager in manufacturing for day/or night shift (12-hour rotation). The successful candidate will be leading a team of experienced manufacturing associates responsible for the manufacture of GMP drug substance. The manager will champion a safe and compliant production environment through structured on floor presence. The manager will be an active participant and role model in Lean culture and continuous improvement programs with responsibility to translate onto the manufacturing floor.

With minimal direction the manager is responsible for leading on the floor operations and staff in manufacturing. The successful candidate must demonstrate strong leadership skills and technical understanding of production operations. This individual will be responsible for supervising, coaching, hiring, and development of floor staff.

The front-line manager will assist in defining area objectives, identifying improvement opportunities, and leading change efforts; effectively directing their team and delivering on short- and long-term Amgen Operational goals.

Compliance:

• Ensure safe working environment

• Ensure cGMP and CFR compliance of operating areas

• Ensure Amgen policies are followed

• Evaluate current operating procedures and recommend changes to management to optimize production. Assure all corporate change control procedures are followed, and Regulatory and QA are notified prior to the changes

• Interact with regulatory agencies

• Assure proper gowning and aseptic techniques are followed

• Undefined

Process/Equipment/Facilities:

• Demonstrate technical mastery of manufacturing processes

• Collaborate with cross-functional teams (i.e. QA/QC, F&E, PPIC, Mfg, PD, Regulatory, etc.) in completing production activities

• Develop, implement and assess solutions for complex problems

• Responsible for resolving problems during operation

• Oversees set up and completion of critical manufacturing processes

Staff Supervision:

• Responsible for staff and team performance

• Responsible for selection, training, evaluation, staff relations and development of staff

• Ensure staff members live by the Amgen Values

• Ensure training programs are maintained

• Ensure adherence to production schedule and maintenance activities

• Interacts with management in optimizing organizational structure and responsibilities

• Ensure plant safety through auditing and evaluations

• Ensure gowning and aseptic techniques training programs are maintained
   

Administrative:

• Interacts with management in planning, developing and maintaining budget

• Assist in developing and maintaining department goals

• Other functional responsibilities may be assigned

All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities. 

What we expect of you

• Doctorate Degree
• Master’s degree and 2 years of experience in pharmaceutical company or GMP environment OR
• Bachelor’s degree and 4 years of experience in pharmaceutical company or GMP environment OR
• Diploma and 8 years of experience in pharmaceutical company or GMP environment
• 4+ years’ experience in GMP technical support/engineering or manufacturing support environment with at least 3 years’ experience in the Pharmaceutical or Biotechnology industries.
• Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources
• Knowledge and experience within a cGMP or other highly regulated environment including a basic understanding of technical elements across engineering, biological or chemical processing
• 5 years process experience in a cGMP manufacturing facility
• 3+ years of experience in a production Area Lead, Specialist or Manager role
• Strong leadership and teambuilding skills (coaching, mentoring, counselling)
• Experience with performance management including performance reviews
• Conflict Resolution skills
• Analytical problem-solving skills
• Project Management skills
• Thorough understanding of regulatory requirements
• Ability to be flexible and manage change
• Excellent verbal and written communication (technical) skills
• Excellent computer skills with Microsoft, EBR/MES, Delta V, Electronic quality systems

Your selection for this role will be subject to fulfilling the medical requirements of this job scope. If so, you will be informed of the medical check(s) that you may need to undergo. All medical related expenses incurred from this medical check shall be borne by the company.

What you can expect of us

As we work to develop medicines for patients, we also invest in our people. Through competitive benefits, development opportunities, and a collaborative culture, we'll support your growth both professionally and personally.

Apply now and help transform the lives of patients while transforming your career.

careers.amgen.com

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values as we continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity Employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.