Director, Biologics Analytical Development (Pivotal and Commercial)

Arbeitsbeschreibung

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 technologies may include but not limited to Mass spectrometry, Analytical ultracentrifugation (AUC), Size exclusion chromatography (SEC), Reversed phase chromatography, Ion exchange chromatography (IEX), Capillary gel electrophoresis (CGE), Light scattering techniques (DLS, MALS) and Molecular analysis.

• Subject matter expert in establishing comprehensive control strategies for biologics products.

• Well versed in FDA and ICH guidelines relating to registration, quality, and compliance concerning drug substance and drug product.

• Proven track record in drafting regulatory documentation at all stages, including IND, BLA, and PAS filings.

• Demonstrated ability of building strong collaborations with other CMC functions.

• Strong business acumen, with ability to balance resource, budget, and program milestones.

• Working knowledge of lab automation, computer validation, data governance, data science, knowledge management and data protection.

• Leadership qualities of the successful candidate include the following: collaboration, building and developing high performing teams, accountability, cross functional engagement and influence, program management, strategic vision, executive presence. Ability to build high performing teams and to set clear and measurable goals for staff and prioritize projects and resources.

People Leader Accountabilities:

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.

• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.

• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.