Director - Section Lead, Specialized Analytics and Capabilities, ADQC, US

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A Section Lead position for Specialized Analytics and Capabilities (Director-level) is available within the Analytical Development & Quality Control (ADQC) department for US Biologics (PTD). This strategic role requires a collaborative leader with a proven track record in biologics development to guide a high-performance team responsible for the end-to-end analytical characterization of complex biologics and small molecule impurities using advanced tools like MS and NMR spectroscopy. Balancing scientific expertise, business acumen, and a customer-centric focus, the successful candidate will drive results in a fast-paced environment, oversee efficient service execution, and advance the department's digital and innovation efforts.

Key Responsibilities:

• Lead, coach, and develop a team of 15-20 comprising of technical leaders and scientists within the Specialized Analytics section of Analytical Development

• Oversee the strategic, operational, and technical deliverables using combined advanced analytics including MS spectroscopy, hyphenated MS spectroscopy techniques, NMR spectroscopy and other complex analytical technologies

• Oversee prioritization, resource planning, and execution of specialized analytics support across multiple programs and business needs including biologics characterization and small molecule impurities testing.

• Drive the MS-based characterization of biologics (mAbs, bispecifics, fusion proteins, ADCs, bioconjugates, etc.) including Sequence variant analysis, Host cell protein analysis and characterization, minor variant characterization, and related advanced characterization work to support a complex biologics pipeline.

• Provide overarching MS strategy to ensure global regulatory alignment and direct response to health authority inquiries.

• Drive adoption of digital tools, data strategies, automation, advanced analytics, and innovative workflows within the analytical organization, in line with overall organizational data and digital strategy 

• Authoring of relevant sections in INDs and IMAs

• Responsible for development and implementation of next-gen analytical tools.

• Set clear expectations for scientific quality, collaboration, accountability, and innovation.

• Foster a high-performance culture of learning and continuous improvement that prioritizes scientific rigor, data integrity, knowledge sharing, and cross-functional collaboration.

• PhD in chemistry, biochemistry, biology, or related field with at least 7+ years' experience; or M.S./B.S. with a minimum of 8-12+ years' experience (respectively) in the pharmaceutical/biopharmaceutical industry. 5+ years of managerial experience.

• Strong understanding of biologics modalities and demonstrated experience with relevant analytical methodologies (HPLC/UPLC, Mass Spectrometry, etc.).

• In-depth scientific and technical knowledge and experience in the analytical development of biologics.

• Demonstrated success in building and leading teams, driving operational performance and achieving business growth.

• Strong business acumen with ability to balance scientific excellence and business priorities

• Highly motivated and self-driven. Good communication skills, organizational skills, detail orientation. Ability to work effectively in a fast paced, multi-disciplinary environment with various projects and timelines. 

Preferred:

• PhD or Master’s degree 

• Large team leadership experience in a complex cross-functional environment

• Background and experience in product development and commercialization

Relocation benefits are available for this job posting.

The expected salary range for this position based on the primary location of South San Francisco, CA is $177,100 - $328,900.  Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.  A discretionary annual bonus may be available based on individual and Company performance.  This position also qualifies for the benefits detailed at the link provided below.

Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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