Sr. Research Scientist II

At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.

• Lead potency technology transfer team and responsible for potency and residual method validation and transfer for late-stage biologics programs. Manage execution in contract testing laboratories.
• Serve as a potency subject matter expert in the commercial Biologics team, working closely with external analytical outsourcing team and quality team to manage the project timeline and troubleshoot potency and residual methods. Demonstrates ability to recognize anomalous and inconsistent results and perform quality event investigation.
• Drive improvement process for the bioassay team and enhance working relationships with internal and external partners.

• Hands-on technical experience in developing, validating, and transferring potency and residual methods.
• Manage execution of method validation and transfer in contract testing laboratories.
• Review and approve technical reports and lead presentations in internal and external technical review meetings.
• Author and review regulatory submissions and provide strategic guidance to CMC teams on bioassay-related topics.
• Provide technical troubleshoot to potency and residual methods during routine release and stability testing and investigate quality events in a team as a subject matter expert.
• Manage project timelines, perform risk assessment, and present project updates to senior leaders.

• Strong knowledge of GMPs and regulatory submissions experience required.
• Experience working under GMP conditions for pivotal/commercial potency assay validation and transfer preferred.
• A thorough understanding of commercial biologics quality control testing for lot release stabilty, and regulatory submission support required.
• Strong communication and interpersonal skills required.
• Have a strong organizational and planning skills and ability to work on multiple projects and manage tight project timelines as needed.
• Ability to work in a complex, dynamic, global environment, thinking strategically and balancing both long and short-term priorities
• Ability to successfully influence across levels and across functions.

• PhD with 5+ years of experience developing, validating, and transferring potency and residual methods in the biopharmaceutical industry.
• Candidates should be self-motivated and organized, familiar with the relevant literature, and enjoy scientific investigation and thinking, proactively identify issues and develop solutions in a collaborative multidisciplinary environment.
• Must have a thorough understanding on biologics production in a GMP environment, GMP compliance, novel route generation and implementation.
• Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills.
• Demonstrates collaborative communication and problem-solving spirit.

The salary range for this position is: $168,980.00 - $218,680.00. 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*.

• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.