Director, Biologics Analytical Development (Pivotal and Commercial)

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. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
 

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We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description
 

Job Description:

We are seeking a talented and highly motivated Director for our Structural Characterization team in Biologics Pivotal and Commercial Analytical Development. Broad experience in analytical development from early development to commercial launch, filing experience with FDA/EMA, and in-depth technology understanding for biological products are the key in this role, which will expand our rapidly growing Foster City team. A solid understanding of GMPs and CMC requirements is expected. Mass Spectrometry expereince is a must.

Responsibilities:

• Provide leadership to a group of structural characterization scientists, including:

  • Mentor and guide scientists in their roles.

  • Set clear expectations and prioritization of work packages.

  • Recruit and hire new talent.

• Accountable for: 

  • Defining critical quality attributes (CQAs) across the late-phase biologics portfolio and building deep understanding of how CQAs relate to the product’s function.

  • Driving continuous improvement of CQA identification strategies.

  • Leading innovation in mass spectrometry initiatives to build a best-in-class structure characterization function.

  • Leading higher order structure deliverables across the late-phase portfolio.

  • Support the design/justification/execution of end-to-end control strategy development through a proactive definition of the product quality targets.

  • Delivering high quality structural characterization work packages for supporting Pivotal INDa and marketing applications.

  • Serve as an analytical project lead (ASTL) for late-phase program overseeing all analytical deliverables.

  • Serve as an author and reviewer of CMC sections in regulatory filings, and support interactions with health agencies.

  • Collaborate across Gilead Pharmaceutical Development & Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs, Clinical Development and Technical Development to ensure timely delivery and successful commercialization of the late-stage Biologics portfolio.

  • Act as a key member of the extended Analytical Development leadership team to shape late-stage development strategies.

  • Demonstrate comprehensive knowledge in key analytical CMC strategic areas including CQAs, separations methods, method bridging, reference standard, comparability, and specifications.

  • Drive for the adoption of novel and state-of-the-art structural characterization technologies and approaches. Recruit, hire, and mentor talent to help cultivate a world class Biologics AD organization.

Basic Qualifications: 

• Ph.D. with 8+ years in Mass Spectrometry or related fields of industrial experience in biologics analytical development and/or structural characterization with people leader accountabilities.

or

• M.S. with 10+ years in Mass Spectrometry or related fields of industrial experience in biologics analytical development and/or structural characterization with people leader accountabilities.

Preferred Qualifications:

• Significant expertise in mass spectrometry and higher order structure techniques commonly used for biologics structural characterization.

• Must have People Leader experience

• Experience with tec