Associate Director - Late Stage Analytical Development

South San Francisco
California, United States of America


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The Position



The Associate Director in Protein Analytical Chemistry leads a group that drives completion of analytical activities in Genentech’s late stage portfolio, including molecular characterization, method development, assessment of comparability, and analytical support.

   

Key Responsibilities



Functional/Technical

  • Develops continuously improving group strategy for our exciting late stage pipeline and ensures tasks are level loaded appropriately and transparently.
  • Fosters group’s analytical development capabilities and business processes
  • Provides technical advice and reviews project plans.
  • Works closely with colleagues in process development, clinical/commercial quality, and regulatory to ensure project success.
  • Reviews and approves test procedures, method validation protocols and reports, and health authority filings for stage programs.
  • Mentors and cross-trains group members.

Member of Leadership Team

  • Accountable as a leader on the Protein Analytical Chemistry team to resource clinical development and technology projects effectively across department.
  • Manages and develops staff to produce a cohesive department that can nimbly and flexibly resource projects.
  • Embodies lean principles and methods while fostering a mindset of quality, innovation and continuous improvement throughout the organization by encouraging experimentation and learning. Is an active and visible change agent, promoting flexible and open mindset to new opportunities. 
  • Ensures the department complies with safety and GMP requirements
  • Approves external submissions from the department.
  • Provides scientific and technical analytical expertise at various forums and committees.   
  • Actively engages in external influencing and industry best practice discussions to advance strategic priorities.

Qualifications

  • PhD in Life Science, Analytical Chemistry, Immunology, Cell Biology or other relevant Life Sciences discipline.  Those with significant relevant experience without a PhD may also be considered.
  • A minimum of 7 years relevant experience in the pharmaceutical or biopharmaceutical industry, with at least 5 years of managerial experience.
  • Strong scientific background in analytical control strategy development and implementation.
  • Extensive in-depth experience with global regulatory filings for clinical, launch, and commercially approved products across a broad range of product classes; e.g. therapeutic proteins, recombinant monoclonal antibodies, antibody drug conjugates.
  • Strong experience in the assessment of technical data and scientific information is required in order to provide technical reviews for documents and regulatory submissions.
  • Ability to manage and motivate groups and think creatively to find solutions to problems.
  • Excellent understanding and technical proficiency with analytical control systems, critical quality attributes, characterization methods, and CMC development processes for recombinant proteins.
  • In depth knowledge and experience in analytical chemistry across a wide range of technologies (HPLC, CE, MS, etc.) is highly desirable.
  • A proven track record with authoring CMC sections.
  • Demonstrated knowledge and execution of Quality Control operations and processes related to biopharmaceutical manufacturing.
  • Highly competent in US, EU, Japan cGMPs and ICH requirements.
  • Ability to identify and define clear problem statement and drive resolution through sound and systematic application of technical knowledge. Innovative and effective in solution development, risk management, and execution.

Who We Are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

The next step is yours. To apply today, click on the "Apply online" button.

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.

At Genentech, we share salary ranges with applicants during the recruiting process, if requested. Third party salary estimates may not be accurate or up-to-date.


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