Manufacturing Specialist - New Product Introductions (NPI)

This is a highly diverse role for an ambitious individual. This role provides unlimited bandwidth to influence key partners cross-functionally, allowing for great visibility vertically within the Amgen Corporate structure.

The Manufacturing Specialist within the Clinical Drug Product Manufacturing Program will assume the responsibility of independently leading projects that support Amgen Thousand Oaks (ATO) Development Supply Chain (DSC) Organization to ensure drug product supply is uninterrupted. The candidate will report within the Building 20 Drug Product filling facility/management structure.

Responsibilities include, but not be limited to; New Product Introductions (NPI) program management and non-capitol project management. The individual will be responsible for leading projects of diverse subjects and complexity. 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 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

Basic Qualifications:

Doctorate degree

OR

Master's degree and 3 years of drug product manufacturing 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:

• 6 + years of bio-pharmaceutical experience within bio-pharmaceuticals manufacturing facility is strongly preferred
• BS in Engineering, Microbiology, or other Life Science discipline
• Ability to solve problems within biologic manufacturing through utilizing analytical thinking and deductive reasoning
• Detail oriented, self-motivated, and ability to pro-actively manage tasks and identify improvement opportunities
• Experience in Aseptic Behavior and Gowning
• Clear and concise technical writing with the ability to adapt content to different audiences
• Influential leadership and project management skills to drive teams to meet project milestones
• Ability to clearly communicate status of the projects to senior leadership, as well as to auditors and inspectors
• Very organized in thinking, ability to coordinate multiple tasks and deadlines and through collaborations assign deadlines and accountability with internal and external partners

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.