drjobs Manager, Manufacturing - 12hr PM

Manager, Manufacturing - 12hr PM

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1 Vacancy
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Job Location drjobs

New Albany, OH - USA

Monthly Salary drjobs

$ 133764 - 133764

Vacancy

1 Vacancy

Job Description

Career Category

Operations

Job Description

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology Inflammation General Medicine and Rare Disease we reach millions of patients each year. As a member of the Amgen team youll help make a lasting impact on the lives of patients as we research manufacture and deliver innovative medicines to help people live longer fuller happier lives.

Our award-winning culture is collaborative innovative and science based. If you have a passion for challenges and the opportunities that lay within them youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Manufacturing Manager

What you will do

Lets do this. Lets 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 a Packaging facility. Responsibility includes maintaining production in full cGMP compliance. Supervises hires and develops staff and ensures production schedules are completed in a shift.

Specific responsibilities include but are not limited to:

Compliance:

  • 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 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

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.

Basic Qualifications:

Doctorate degree

Or

Masters degree and 3 years of experience in the pharmaceutical medical device or biotechnology industry

Or

Bachelors degree and 5 years of experience in the pharmaceutical medical device or biotechnology industry.

Or

Associates 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 you must have experience directly managing people and/or leadership experience leading teams projects prograns or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

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
  • 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

What you can expect of us

As we work to develop treatments that take care of others we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to relevant skills experience and qualifications.

In addition to the base salary Amgen offers a Total Rewards Plan based on eligibility comprising of 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 that may include:

  • A 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
  • Flexible work models including remote and hybrid work arrangements where possible

Apply now

for a career that defies imagination

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

In any materials you submit you may redact or remove age-identifying information such as age date of birth or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

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 to 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.

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Salary Range

114259.00 USD - 133764.00 USD

Required Experience:

Manager

Employment Type

Full-Time

Company Industry

About Company

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