Associate Scientist, BAO QC

Role and Responsibilities:

Gilead Sciences is currently seeking an Associate Scientist in the Biologics Analytical Operations (BAO) Quality Control group located in Oceanside, CA. The successful candidate will possess a detailed understanding of Quality Control in support of large molecule manufacturing. The candidate must be highly motivated to contribute to the development of biologics targeting unmet medical need by participating on a team that supports multiple clinical and commercial programs. This role will have responsibility for supporting internal GMP activities as well as activities at external contract testing sites, internal and external method establishment, product performance monitoring, existing methods and specifications, quality-impacting change controls.

Key Responsibilities and Job Functions:

• Provide QC support and represent QC requirements to analytical development activities, such as method validation, verification, and transfer
• Provide QC support to the drafting of technical protocols and reports
• Perform investigations as required to support commercial products
• Work on complex problems where analysis of situations or data requires in- depth evaluation of various factors and strong judgment in resolving problems
• Ensure that analytical activities, including method establishment, testing, method monitoring, and data reporting are performed according to established timelines in support of business objectives
• Own efforts in support of Quality Systems records, deviations, CAPAs, and change controls
• Mentor junior QC personnel and identify opportunities for professional development in line with individual strengths
• Assure compliance with environmental and safety regulations.

Knowledge, Experience and Skills:

• Ability to operate independently and with minimal supervision
• Thorough understanding of good manufacturing practices
• Strong technical writing skills
• Subject matter expertise in one or more analytical areas, such as HPLC, CE, Compendial Methods, Bioassays, etc.
• Excellent scientific and business communication skills (both verbal and technical) and interpersonal skills
• Demonstrated ability to successfully interact with other functions on projects that involve negotiation and collaboration with cross-functional peers.

Basic Qualifications:

• 10+ years of relevant experience with an AA
• 8+ years of relevant experience with a BS or BA.
• 6+ years of relevant experience with an MS.

If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.avature.net/Gilead

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