Principal Scientist, Quality Control Biologics (Analytical Lifecycle Management)

Principal Scientist, Quality Control Biologics (Analytical Lifecycle Management)

Job Overview

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19, and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

Job Description

The Principal Scientist, Analytical Lifecycle Management is vital for the success of Clinical Biologics QC, providing support for strategic leadership and oversight of daily operations. Responsibilities include managing Clinical specification strategies, reference standards, raw materials, and critical reagents programs, analytical method validations and transfers, and the compendial review program. The role will contribute to monitoring QC test method execution and leading the analytical lifecycle management of Clinical 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 an ability to develop a vision for Quality Control functions and have shaped the capabilities of the function to fulfill that vision.
• Demonstrated the ability to influence process and outcomes across functions.
• Willing to support future laboratory work.
• Willing to support Commercial QC team.

Qualifications:

• 10+ Years experience with BS OR
• 8+ Years with MS OR
• 5+ Years with PhD in Chemistry, Biochemistry or related field.
• 2+ years of relevant experience in a GMP Lab environment, including knowledge of analytical testing, familiarity with laboratory instrumentation.
• Preferred experience in Biopharmaceutical or Pharmaceutical quality control. Stays ahead of shifting trends in industry and GMP systems/software (e.g., LIMS, QMS, Empower).
• 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.

The salary range for this position is: $182,070.00 - $235,620.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. 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 insurance plans.

For additional benefits information, visit: Gilead Benefits

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences.