Executive Director, Analytical Development (South San Francisco, CA)
The Executive Director of Analytical Development will be the functional lead and have primary responsibility for analytical method development, optimization, fit-for-purpose method validation and stability testing of small molecules, antibodies, antibody drug conjugate drug substance and drug product, and critical reagents specific to Sutro’s unique cell-free technology in development. The successful candidate will bring broad expertise in organic synthesis, process chemistry and biologics development and manufacturing. The successful candidate will work closely with Discovery and Research, Quality Control, Quality Assurance, Process Development, Formulation Development, Manufacturing, Supply Chain, Project Management, and Regulatory CMC to ensure timely analytical method development & fit-for-purpose validation, as well as the timely testing and release of materials. This person will be responsible for the collection of data and the finalization of the reports and summaries required to support global regulatory submissions. In addition, this person will be responsible for establishing and maintaining excellent working relationships with external business partners, contract manufacturing organizations, and contract testing laboratories, including facilitating method transfers. Prior experience with method development/validation and the demonstrated ability to work effectively with contract testing laboratories and contract manufacturing organizations for analytical development and quality control testing are requirements for this position. This position reports to the Senior Vice President of Process, Analytical and Formulation Development (PAFD) and contributes fully in strategy development, planning and execution of the PAFD remit.
- Serve as the primary Analytical Development technical expert of the company, internally, with CMOs and external business partners, and with the FDA and other regulatory agencies to ensure Sutro is appropriately represented in technical matters.
- Establish appropriate AD team staffing plan to support aggressive growth plans and hire world-class scientists.
- Advance and manage Sutro’s product specifications and stability testing.
- Help establish CRO/CMO landscape for analytical testing as required and ensure robust processes and analytical method development of small molecules, antibodies, antibody drug conjugates, and critical reagents and raw materials used in Sutro’s unique technology platform.
- Identify and address technical and validation gaps in analytical methods in preparation for BLA/MAA submissions and product commercialization.
- Work with QC and CMOs to devise and implement improvements in analytical methods.
- Identify, evaluate, and implement new analytical methods and technologies.
- Ensure compliance of analytical testing activities with applicable compendia (eg., USP, NF, EP) and regulatory guidance documents.
- Coordinate and oversee analytical method transfers to and between CMOs and CTLs.
- Manage the development and supplies of reference standards and critical reagents across testing sites.
- Contribute to or oversee the investigation and resolution of out-of-specification (OOS) and out-of-trend (OOT) testing results.
- Work collaboratively with Development/Manufacturing/Supply Chain, to ensure that analytical methods are aligned with process needs/capabilities and product requirements.
- Serve as primary author or reviewer of CMC sections related to pharmaceutical development, analytical methods and method validation, specifications, and stability in INDs, IMPDs, MAAs, BLAs, and other regulatory submissions.
- Work closely with Research and Discovery teams to ensure smooth developability of candidate molecules.
- Build, coach, and mentor to ensure effective execution of roles and responsibilities and professional development for AD team members.
- Advanced degree (PhD) in Chemistry, Biochemistry, Analytical Chemistry, or a related field preferred.
- At least 15 years relevant combined QC and AD experience. Previous 10 years of managerial experience required.
- Experience leading Analytical Development team and working in partnership with process development team to deliver appropriate product control strategy.
- Comprehensive working knowledge of Good Manufacturing Practices (cGMPs) and Regulatory Guidance Documents as they relate to development, testing and stability of pharmaceutical products.
- Experienced in all phases of biologics drug development is a plus.
- Experience with development of linker-warheads for ADCs is preferred.
- Ability to travel up to 10-20%.
- Ability to effectively prioritize and demonstrated ability to deliver high-quality results on tight timelines.
- Excellent written and verbal communication skills.
- Accuracy and attention to detail.
- Excellent cross-functional team participation skills.
- Outstanding problem-solving skills including the ability to devise and implement practical solutions to resolve complex issues in a virtual environment.
- Willingness to work in a dynamic and changing corporate environment.
Sound exciting? Apply today and join our team!
Sutro Biopharma, Inc. requires all new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Sutro will consider requests for reasonable accommodations.Sutro provides a competitive benefits package that includes a choice of health, dental, and vision insurance, life insurance, flexible spending accounts, 401K plan, PTO, ESPP (Employee Stock Purchase Plan) and stock options.
As an equal opportunity employer, we believe in fostering a culture that is inclusive and values diversity in background and opinions. Sutro Biopharma hires extraordinary individuals into every position in the company and is committed to the diversity of our team. Our company progresses without regard of race, ethnicity, gender, sexual orientation, religious belief, age, disability or citizenship status. We are dedicated to creating a safe environment where our employees can grow and succeed together.
Salaries listed on jobsites may not be representative of salary ranges at Sutro Biopharma.
We look forward to hearing from candidates who are interested in exploring opportunities with Sutro! Our People & Culture team/hiring managers are unable to respond and do not accept solicitations from third-party agencies.
Sutro Biopharma, Inc., located in South San Francisco, is a clinical-stage drug discovery, development and manufacturing company. Using precise protein engineering and rational design, Sutro is advancing next-generation oncology therapeutics.
Sutro is dedicated to transforming the lives of cancer patients by creating medicines with improved therapeutic profiles for areas of unmet need. To date, Sutro’s platform has led to cytokine-based immuno-oncology therapies, ADCs, vaccines and bispecific antibodies directed at precedented targets in clinical indications where the current standard of care is suboptimal.
The platform allows it to accelerate discovery and development of potential first-in-class and best-in-class molecules through rapid and systematic evaluation of protein structure-activity relationships to create optimized homogeneous product candidates.
In addition to developing its own oncology pipeline, Sutro is collaborating with select pharmaceutical and biotech companies to discover and develop novel, next-generation therapeutics. As the pace of clinical development accelerates, Sutro and its partners are developing therapeutics designed to more efficiently kill tumors without harming healthy cells.