Amgen

Manufacturing Specialist, Drug Product

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Sep 08, 2019
Ref
R-80645
Required Education
High School or equivalent
Position Type
Full time
The Amgen Thousand Oaks, Building 20 (B20) Drug Product Manufacturing facility directly supports Amgen's pipeline of clinical, and soon to be commercial, drug product supply to patients across the globe. The Manufacturing Specialist-Drug Product role offers the opportunity to collaborate in a dynamic environment with multiple functional areas such as Quality Assurance, Quality Control, Engineering, Quality Engineering, Facilities, Maintenance, Process Development, Process Engineering, Regulatory Compliance, etc.. on a routine basis. The role offers opportunities to develop deeper technical understanding of the Drug Product manufacturing operations, equipment, facilities, and planning activities. The position will require serving as the manufacturing liaison with subject matter experts across various functional areas who also support B20, as well as with external vendors. The Manufacturing Specialist is responsible for technical success of processes that are assigned and will be accomplished through pro-active evaluations, well-constructed and executed action plans, and on-going. The role will require an ability to complete aspects of many types of roles including, but not limited to: project management, engineering, vendor engagement and relationship building, training, and risk evaluation.

The Manufacturing Specialist will be specifically responsible for:

o Serving as the Product Process Owner (PPO) of identified processes in B20 Fill/Finish facility that support clinical and commercial production, responsible for the technical success of the processes that you are assigned.

o Executing with a total ownership mindset of the processes that you are assigned.

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

o Supporting new technology initiatives within the B20 Fill/Finish facility by serving as the single point of contact and manager of technical knowledge of the technology advancements for manufacturing.

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

o Effectively engaging and participating 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 Coordinating and assisting with scheduling of various types of studies (e.g., container qualifications) and quality investigations across departments to ensure successful completion of project timelines.

o Identifying and elevating critical and high impact events to senior management

o Utilizing appropriate systems for job duties (SAP, CCMS, QMTS, and LIMS etc.).

o Identifying and implementing process and safety improvements.

o Communicating project timelines, project hurdles, and project work at various levels within manufacturing.

o Interacting with internal/external audit teams including regulatory agencies, as directed.

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

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

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

o Owning change controls and SOPs associated with the processes that you are assigned

Basic Qualifications:

Doctorate degree

OR

Master's degree and 3 years of drug product manufacturing or operations experience

OR

Bachelor's degree and 5 years of drug product manufacturing or operations experience

OR

Associate's degree and 10 years of drug product manufacturing or operations experience

OR

High school diploma / GED and 12 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 Bachelor's or Master's degree in Chemical Engineering, Mechanical Engineering, the Physical Sciences, or a related field

o Proficient working within a fast-paced environment, specifically as a technical leader with the capacity to complete and/or facilitate objective 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.

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.