Manager Manufacturing (12hr PM) at Amgen
New Albany, Ohio, USA -
Full Time


Start Date

Immediate

Expiry Date

05 Dec, 25

Salary

0.0

Posted On

06 Sep, 25

Experience

3 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Availability, Biotechnology Industry, Written Communication, Scheduling, Presentation Skills, Leadership, Conflict Resolution, Mentoring, Regulatory Requirements, Addition

Industry

Pharmaceuticals

Description

JOIN AMGEN’S MISSION OF SERVING PATIENTS

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s 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, you’ll 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, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

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, 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
Responsibilities

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 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
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