Associate Director, Late Stage Analytical & CMC Development (South San Francisco, CA)

Sutro Biopharma, Inc. is seeking a driven and talented scientific leader to join our Analytical Development team as we change the future of oncology. This role will support late-stage analytical development for antibody drug conjugates, monoclonal antibodies, bispecific antibodies, cytokines, antibody drug conjugates, and small molecule drug linkers. While collaborating with cross-functional departments, you will play a key role in maximizing our technology and progressing ournovel therapeutics through Phase II to BLA. We are dedicated to making a difference in the lives of patients, both as individuals and as part of a team.

Responsibilities

• Serve as overall project manager for Process and Analytical Development late-stage IND and BLA Module 3 creation to ensure on-time submission
• Drive late-stage CMC Module 3 requirements applicable to Analytical Development and/or QC (e.g. CQA analysis, specification justifications, etc.)
• Plan and oversee studies that support late-stage development (e.g. process residuals, elemental impurities, extractables and leachables, etc.) that are conducted at CROs
• Act as primary author or reviewer of CMC sections related to analytical development, analytical methods and method validation, specifications, stability, and other Module 3 requirements in INDs, IMPDs, MAAs, BLAs, and other regulatory submissions
• Critically review primary documentation that supports Module 3 development to ensure all phase-appropriate requirements are met.
• Contribute to the hand off of late-stage activities from AD to QC (and/or CMO/CROs) that enable commercial production and supply.

Qualifications

• Ph.D. in analytical chemistry, biochemistry, molecular biology or related scientific field and 8+ years of industryexperience in analytical development and QC OR
• B.S./M.S. in analytical chemistry, biochemistry, molecular biology or related scientific field and 12+ years of industry in analytical development and QC.
• Requires broad expertise in analytical development, Quality Control, and late-stage development.
• Previous experience creating CMC sections for BLA and devising strategy and addressing deficiency letters.
• Project management experience with significant regulatory requirements and OP/CAPEX spend is a must.
• Demonstrated leadership ability, including a commitment to mentorship and development of personnel.
• Flexibility to work on multiple projects in a fast-paced environment is essential.
• Good communication skills are essential. 

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.

The anticipated salary range for fully qualified candidates applying for this role at Sutro Biopharma’s California based locations will be [$170,000 – $185,000] (not including bonus, equity, and benefits). The final salary offered will be dependent on several factors that include and are not limited to relevant previous experience, job responsibilities and duration of experience, the type and length of experience within the industry and education.

Company Overview

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.