Senior Manager Manufacturing Support at Amgen
New Albany, Ohio, USA -
Full Time


Start Date

Immediate

Expiry Date

14 Nov, 25

Salary

172789.0

Posted On

14 Aug, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Project Management Skills, Life Sciences, Regulatory Requirements, Operational Excellence, Availability, Product Manufacturing, Statistics, Presentation Skills, Conflict Resolution, Continuous Improvement, Coaching, Mentoring, Addition, Combination Products

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.
Senior Manager Manufacturing Support

BASIC QUALIFICATIONS:

Doctorate degree and 2 years of manufacturing support experience
or
Master’s degree and 6 years of manufacturing support experience
or
Bachelor’s degree and 8 years of manufacturing support experience
or
Associate’s degree and 10 years of manufacturing support experience
or
High school diploma / GED and 12 years of manufacturing support experience
In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

PREFERRED QUALIFICATIONS:

  • Educational background in Life Sciences or Engineering
  • Availability to support the manufacturing operation on Non Standard Shifts, Nights or Weekends (On call and/or on site) as needed
  • Experience with Drug Product manufacturing technologies / equipment, specifically Assembly and Packaging manual and automated equipment
  • Regulatory knowledge and interactions
  • Knowledge of conflict resolution and negotiating skills
  • Ability to partner with other departments / functions / areas
  • Analytical problem solving
  • Considerable organizational skills
  • Technical writing and presentation skills.
  • Basic project management skills.
  • Knowledge of control charting and statistics
  • Experience in coaching, mentoring and counseling
  • Ability to deal with and manage fast and constant change
  • Ability to set goals
  • Ability / experience in working in fast paced manufacturing environment where issues must be assessed, understood and resolved immediately
  • Customer satisfaction mentality
  • Ample knowledge of cGMP Regulations around Sterile Product Manufacturing, Combination Products and other relevant area regulatory requirements
  • Ability to maintain an environment and culture of operational excellence and continuous improvement
  • Proven experience implementing a continuous improvement program based on performance monitoring through KPIs
  • Desire to create an environment with Diversity, Inclusion and Belonging
Responsibilities

Let’s do this. Let’s change the world. In this role you will be responsible for leading and managing the process owners at the ANA Assemble and Packaging Plant. The process owners are responsible for documentation (SOP, PTC, FORM, Manufacturing Procedure), QMS records (Deviation, CAPA, Change Control, CAPA EV), Electronic Batch Records and Risk Assessments. Reporting to the Executive Director Plant Manager, this role will support the other functional areas Assembly and Packaging (Vials, Syringes, Devices), Engineering, Process Development, Quality, Validations, IS, Regulatory and other functions as required. This role is crucial for ANA’s success, it is a key contributor in ANA’s daily operation and is considered part of the Leadership Team.

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