Sr Associate Manufacturing - New Product Introductions (NPI)

This Manufacturing Senior Associate position will support clinical New Product Introductions (NPI) of drug product manufacturing operations in Thousand Oaks, CA. The Sr. Associate is responsible for:

New Product Introductions (NPI) program management. The incumbent will have proven strong communication and collaborative capabilities, both within and outside of the immediate team. The Manufacturing Specialist - New Product Introductions (NPI) will successfully inform, influence, and assign accountability to members of cross-functional teams that include; Manufacturing, Plant Quality Assurance, Process Development, Clinical Process Engineering, Analytical Sciences, Quality Control, Supply Chain, and Regulatory Affairs.

Job scope and responsibilities:

• Change control ownership, ensuring records are comprehensive and compliant per GMP regulatory procedures. This must occur with a Right the First-Time approach.
• Timely closure of change control records in relation to procedural guidance and/or disposition timelines
• Identifying improvement opportunities within the organization and take pro-active steps to build consensus to implement those opportunities
• Succinctly communicate verbally and in writing to staff and leadership
• Presenting records and business processes to a variety of audiences, including auditors and inspectors
• Participating/leading Lean Transformation activities
• Support business initiative which will include, but not limited to: metric management, resource modeling, and special project implementation

Basic Qualifications:

Master's degree

OR

Bachelor's degree and 2 years of biotech or pharmaceutical manufacturing, process development or quality experience

OR

Associate degree and 6 years of biotech or pharmaceutical manufacturing, process development or quality experience

OR

High school diploma / GED and 8 years of biotech or pharmaceutical manufacturing, process development or quality experience

Preferred Qualifications:

• Degree in Chemical Engineering, Industrial Engineering or Life Sciences
• Experience with Current Good Manufacturing Practices (cGMP)
• Ability to be flexible and manage change
• Experience participating in and leading cross-functional teams
• Experience in managing multiple, competing priorities in a fast-paced environment
• Strong scientific, technical interactions with partner organizations such as PD and F&E.
• Experience in GMP Tech Support roles, GMP operations, process development or scheduling.
• Experience with aseptic operations in Grade 5 (Class 100) cleanrooms.
• Technical knowledge of Drug Product processing and broad understanding of related disciplinary areas.
• Background in lean manufacturing methodologies and operational excellence
• Expertise in electronic systems used in manufacturing (MES/Werum, LIMS, Maximo, CCMS, etc.)

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.