23 days old

Sr. Associate Manufacturing, Drug Product

Amgen
Thousand Oaks, CA 91360
  • Job Code
    121586155
Amgen

Job ID: R-100873
Location: Thousand Oaks, CA, US 91360

Job Description

The Amgen Thousand Oaks, Building 20 (B20) Drug Product Manufacturing facility supports Amgen's clinical pipeline and soon to be commercial Drug Product supply to patients across the globe. The Senior Associate Manufacturing role offers the opportunity to collaborate in a dynamic environment with multiple functional areas such as Drug Product Manufacturing, Quality Assurance, Quality Control, Engineering, Quality Engineering, Facilities, Maintenance, Process Development, Process Engineering, Regulatory/Compliance on a routine basis. The role offers opportunities to develop deeper technical understanding of the Drug Product manufacturing operations, equipment, facilities, and planning. The position requires the incumbent to serve as the technical manufacturing liaison with subject matter experts across various functional areas who support B20, as well as with external vendors. The Senior Associate Manufacturing is responsible for technical success of processes that are assigned. The incumbent will achieve successful outcomes through pro-active evaluations successfully executed action plans.

The role will require an ability to complete aspects of many types of roles including, but not limited to: project management, engineering, vendor engagement, relationship building, training, and risk assessment. This role requires high verbal and written communication capabilities.

The Senior Associate Manufacturing will be specifically responsible for:

o Execute with a total technical ownership mindset of the processes that are assigned.

o Serve as the Product Process Owner (PPO) of identified processes in B20 Fill/Finish facility that support clinical and commercial production

o Support operations and processes as needed during off hours (nights and/or weekends)

o Own SOPs associated with the processes that you are assigned.

o Engage with staff members within the manufacturing area to ensure technical understanding of the processes that you are assigned.

o Understand and verbalize the technical requirements of B20 manufacturing during cross functional meetings, document reviews, and project planning sessions.

o Effectively engage and participate within a Lean culture environment where continuous improvement behaviors are expected, and programs are employed. The role will require incorporation of Lean concepts into assigned project(s).

o Coordinate and assist with scheduling of various types of studies and quality investigations across departments to ensure successful completion of project timelines.

o Identify and elevate critical and high impact events to senior management

o Utilize appropriate systems for job duties (SAP, Trackwise, LIMS, SmartSheets, etc.).

o Support the implementation of process and safety improvements.

o Communicate project timelines, project hurdles with proposed solutions, and project work at various levels within manufacturing.

o Support internal/external audits

o Support the introduction of new products and technologies into the facility.

o Troubleshoot and perform initial assessment of events that have the potential to impact area safety and product quality.

Basic Qualifications:

Masters degree

OR

Bachelors degree and 2 years of drug product manufacturing or operations experience

OR

Associates degree and 6 years of drug product manufacturing or operations experience

OR

High school diploma / GED and 8 years of drug product manufacturing or operations experience

Preferred Qualifications:

o At least 10 years of biopharmaceutical experience within biopharmaceuticals manufacturing facility with preferred focus within aseptic and/or sterile filling environments

o Bachelors or Masters degree in Chemical Engineering, Mechanical Engineering, the Physical Sciences, or a related field

o Strong project management capabilities within an autonomous manner.

o Proficient working within a fast-paced environment, specifically as a technical leader with the capacity for objective, evidence-based decision making

o Comfortable advocating to senior management for the needs of your assigned project, area, and work team

o Strong working knowledge of lean concepts and application within a regulated manufacturing environment.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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, or disability status.



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Posted: 2020-07-15 Expires: 2020-08-15

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Sr. Associate Manufacturing, Drug Product

Amgen
Thousand Oaks, CA 91360

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