BioSpace · 3 days ago

Research Scientist, Biologics Quality Control

Foster City, CA

Full-time

Onsite

Senior Level

$154K/yr - $199K/yr

8+ years exp

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Comp. & Benefits

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Responsibilities

Manage QC samples, shipping, and testing logistics, reference standard inventories, and data entry from CTLs/CMOs into Gilead's LIMS.

Provide oversight of commercial specification strategies, reference standards and critical reagents programs, analytical method validations and transfers, and the compendial review program.

Manage the release testing supporting Gilead's commercial biologics drug substances and drug products.

Qualification

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Quality controlGMP principlesBiologics quality controlStrategic planningProblem-solvingHard-workingJudgmentCreativityInnovativenessMotivationInfluenceCommunicationCollaboration

Required

Experience over a broad set of Quality Control sub-functions with extensive knowledge of industry best practices and trends.

In-depth understanding and application of GMP principles, concepts, practices and standards in the US and internationally.

Must be able to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories.

Must be able to develop solutions to complex problems, which require a high degree of ingenuity, creativity and innovativeness.

Must be able to exercise judgment and independently determine and take appropriate action where precedent may not exist.

Proven ability to work with senior management to develop and ensure the implementation of Company-wide long-term solutions.

Demonstrated the ability to motivate and engage individuals.

Demonstrated the ability to influence process and outcomes across functions.

PhD in Chemistry, Biochemistry or related field OR 8+ years' related experience with a BS OR 6+ years' experience with a MS in Chemistry, Biochemistry or related field.

Knowledge and experience in Biologics quality control. Stays ahead of shifting trends in industry.

Must think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems.

Strong organizational and planning skills.

Shows excellent verbal and written communication skills and collaborative interpersonal skills.