Scientist — Quality Control Biologics; Analytical Lifecycle Management

Scientist — Quality Control Biologics
- Analytical Method Validation and Transfer

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Key Responsibilities:

Analytical Method Validation and Transfer - Commercial Analytical Lifecycle Management:

The Scientist, Analytical Lifecycle Management is vital for the success of Commercial Biologics QC, providing support for strategic leadership and oversight of daily operations. Responsibilities include supporting Commercial analytical method validations and transfers, compendial review program, and specification setting strategies. The role will contribute to monitoring QC test method execution and leading the analytical lifecycle management of Commercial biologics drug substances and drug products.

Department

Global Quality Control – GQC-Biologics

Job Responsibilities

• 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.
• Willing to support future laboratory work.
• Willing to support Commercial QC team.

Basic Qualifications:

• PhD in Chemistry, Biochemistry or related field OR
• Master's Degree in Chemistry, Biochemistry or related field and 4+ years of relevant experience OR
• Bachelor's Degree in Chemistry, Biochemistry or related field and 6+ years of relevant experience OR
• Associate’s Degree in Chemistry, Biochemistry or related field and 8+ years of relevant experience OR
• High School Degree and 10+ years of relevant experience

Preferred Qualifications:

• Experience authoring validation protocols and reports for commercial or late-stage products.
• Experience developing method transfer plans, including authoring gap assessments, master transfer plans, protocols, and reports.
• Experience interacting with and providing oversight of QC activities at CDMOs and CTLs.
• Experience leading or participating in the development of product specification setting for commercial or late-stage products.
• 1+ year of relevant QC experience in a GMP Lab environment, including knowledge of analytical testing, familiarity with laboratory instrumentation and GMP systems/software (e.g. LIMS, QMS, Empower) for biologics drug substances and drug products.
• Experience in Biopharmaceutical or Pharmaceutical 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.

Additional information:

The salary range for this position is: $ - $. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life…