Opportunity to join the global leader in research development support breast cancer patients!

Job Summary:

• Provide Quality oversight to biologics Contract Manufacturing Organization (CMO) operations including but not limited to review/approval of CMO batch records, disposition, deviations, CAPAs, change controls, CAPAS, and inspection management.

• Responsible for reviewing CMO’s deviations, CAPAs, and change controls related to biologic intermediate and final drug product manufacturing (i.e., mAb, drug substance, drug product), process, equipment, facility, and computerized systems contributing to the oversight of key strategic, tactical, and operational goals.

• Independently review, initiate, complete, and thoroughly document critical, major, and minor deviations, CAPAs, and change controls at CMO’s within Gilead’s document control system; and Gilead internal quality events related to GxP operations.

• Participate in developing of or provides review and feedback for Standard Operating Procedures to ensure quality objectives are met.

• Participate in cross-functional meetings with stakeholders and leadership to ensure alignment and compliance to EQO expectations.

Qualifications:

• BS or MS in Chemistry, Biochemistry, Microbiology or Biology or related discipline.

• 4 to 6 years of experience within the biologics manufacturing industry.

• Need to have experience with technical writing, deviations, change controls and CAPAs.

Why work here?

This is an amazing opportunity to join one of the global leaders development revolutionary therapeutics in breast care patients.

Work Schedule:

• Monday through Friday (1st shift) - Hybrid model working 2 days home and 3 days onsite.

• This position is a 4 year long term contract with full benefits, holidays, 401k plan and PTO.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.