BioSpace · 2 days ago

Senior Associate Scientist, Biologics Quality Control

Foster City, CA

Full-time

Onsite

Senior Level

$133K/yr - $172K/yr

4+ years exp

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Comp. & Benefits

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Responsibilities

Contribute to the development and implementation of end-to-end Quality Control strategy for Gilead's portfolio of biologics products.

Contribute to staff development, budgeting and cost control, and strategic planning of the Biologics Quality Control department.

Demonstrate a clear understanding of biological product testing methods and assays for effective troubleshooting and remediation of atypical results.

Qualification

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Biologics Quality ControlGMP PrinciplesQuality PrinciplesQuality TheoriesSenior Management CollaborationContract Laboratory ManagementProcess InfluenceBiologics Industry KnowledgeResource AllocationProblem-SolvingCreativityInnovativenessJudgmentCollaboration

Required

Experience with Biologics Quality Control sub-functions and extensive knowledge of industry best practices and trends.

Experience with or demonstrated capacity to learn 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 support for Company-wide long-term solutions.

Demonstrated an ability to manage and influence Quality Control testing at contract laboratory facilities and ensure alignment with Gilead's GMP policies.

Demonstrated the ability to influence process and outcomes across functions.

BS degree in Chemistry, Biochemistry or related field with 6+ years' experience, or MS degree with 4+ years' experience.

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.