Company

AmgenSee more

addressAddressNew Albany, OH
salary Salary$112,563 - $132,215 a year
CategoryAccounting/Finance

Job description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Manager Manufacturing

Live

What you will do

Let’s do this. Let’s change the world. In this role you will be managing and leading all aspects of either a small manufacturing production area, or a section of a larger production area in an Inspection and Packaging facility. Responsibility includes maintaining production in full cGMP compliance. Supervises, hires, and develops staff and ensures production schedules are completed.

Specific responsibilities include but are not limited to:

Compliance:

  • Evaluate and approve reports and protocols.
  • Ensure cGMP and CFR compliance of manufacturing areas.
  • Revise, update, and review procedures
  • Coordinate the development and revision of SOPs.
  • Evaluate current manufacturing procedures and recommend changes to management 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

Process/Equipment/Facilities:

  • Ensure maintenance and re validation of systems.
  • Collaborate with cross-functional teams (i.e. QA/QC, PPIC, Clinical Mfg, PD, Regulatory, etc.) in completing production activities.
  • Develop, implement and assess solutions for problems.
  • Responsible for resolving problems during operation.
  • Coordinates set up of critical new manufacturing processes.

Staff Supervision

  • Responsible for selection, training, evaluation, staff relations and development of staff.
  • Ensure training programs are maintained
  • Ensure scheduling of production and maintenance activities.
  • Interacts with management in optimizing organizational structure and responsibilities
  • Ensure plant safety through auditing and evaluations.

Administrative:

  • Interacts with management in planning, developing and maintaining budget.
  • Assist in developing and maintaining department goals

Shift:

  • This position will be supporting shift work. Shifts are to be determined

Win

What we expect of you

We are all different, yet we all use our outstanding contributions to serve patients. The professional we seek will possess these 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.

And

Previous managerial experience directly managing people and/or experience leading teams, projects, programs or the allocation of resources.

Preferred Qualifications:

  • Educational background in Science, Engineering or Business Administration
  • Availability to work on a third (3rd shift)
  • Strong Managerial skills
  • Non-Conformance and CAPA
  • Ensure that all Non-conformance are triage within the established goal.
  • Leadership and team building
  • Verbal communication
  • 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

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

  • Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans and bi-annual company-wide shutdowns
  • Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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.

Benefits

Disability insurance, Health insurance, Dental insurance, Flexible spending account, Vision insurance, Retirement plan
Refer code: 8143487. Amgen - The previous day - 2024-02-07 09:46

Amgen

New Albany, OH

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