Amgen

Clinical Drug Product Program Specialist

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Sep 08, 2019
Ref
R-81649
Required Education
High School or equivalent
Position Type
Full time
This is a highly diverse role for self-motivated and managed individuals. This role also provides unlimited bandwidth to influence cross-functionally, allowing for great visibility vertically within the Amgen Corporate structure.

The Clinical Drug Product Program Specialist will assume the responsibility of independently managing 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 B20 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 is responsible for leading projects of diverse subjects and complexity. The individual must display strong collaborative capabilities, both within and outside of the immediate team. The Clinical Drug Product Program Specialist will be expected to influence cross-functionally on teams that sometimes include; Manufacturing, Plant Quality Assurance, Process Development, Clinical Process Engineering, Analytical Sciences, Quality Control, Supply Chain, and Regulatory Affairs.

The individual will be responsible for:
  • Change control ownership, ensuring records are comprehensive and compliant per procedures. This must occur with a Right the First-Time mentality.
  • Timely closure of 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
  • Succinct verbal and written communications to staff and leadership
  • Presenting records and business processes to auditors and inspectors
  • Participating/leading Lean Transformation activities

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:
  • BS in Engineering, Microbiology, or other related field that builds and requires analytical thinking, problem solving, and biologic manufacturing
  • A very pro-active mindset and work approach
  • Experience in Aseptic Behavior and Gowning,
  • 6 years of bio-pharmaceutical experience within bio-pharmaceuticals manufacturing facility
  • Proven capability to analytically assess information and apply deductive reasoning
  • Clear and concise technical writing
  • 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
  • Strong, demonstrable project management skills
  • Very organized in thinking, work day approach, and through collaborations 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.