Senior Manager, Quality Control – Compliance (San Carlos, CA)
Sutro Biopharma, Inc. is looking for an experienced, energic, and dynamic Senior Manager of Quality Control Compliance to support and implement phase-appropriate QC specifications setting, product expiry dating, reference standard and critical reagents, SOPs and other document writing supporting Sutro’s custom reagents, intermediates, and DS/DP manufactured internally and externally. The successful candidate will have a both a technical understanding of analytical and microbiological test methods, method transfers, and data trending, and an understanding of quality systems, compliance, and regulatory (global). Excellent verbal and written communication skills, time management skills, and critical thinking skills are essential. This role directly interfaces with internal and external Quality Assurance, Analytical Development teams, and external partners.
- Development and implementation of phase-appropriate specifications, stability, product-expiries, reference standard and critical reagents programs to support internal and external manufacturing for globally filed products
- Provide subject matter expertise for QC methods such as HPLC, CE, IEF, ELISA, bioburden, endotoxin and compendial methods required for the release and stability testing of raw material, in-process, and final product; experience with antibody, antibody-drug conjugates, and small molecules is highly preferred
- Prepare and review QC documents (protocols, reports, SOPs, special studies, etc.) to support QC analytical and microbiology laboratory operations
- Support deviation/OOS investigations as it relates to analytical QC testing
- Work closely within QC and cross-functionally representing QC with QA, Manufacturing, and tech transfer departments to ensure project timelines are met
- Maintain high quality and compliance standards while representing Sutro with external partners
- Author and review regulatory documents for Sutro and partners
- Provide support during inspections and regulatory audits
- Proactively identify and troubleshoot issues to prevent missed timelines and identify opportunities for improvement in QC analytical laboratory operations
- Establish credibility as the SME for all QC issues at Sutro Biopharma inside and outside the organization
- Ensure adherence to GMPs, GLPs, GCPs, and GDPs
- BS or MS in Chemistry, Biochemistry, Pharmaceutical Sciences or related field
- 10+ years with BS or 8+ years with MS in QC experience in a cGMP biologics regulated manufacturing environment is required
- Working knowledge of antibody, antibody drug conjugates and protein analytical methods is strongly preferred
- Knowledge in ICH/USP/EP/JP guidelines as it relates to QC methods, validation, stability, reference standards, specifications, and expiry dating
- Experience managing QC activities at CMOs and CTOs, including method transfers, at all clinical stages is preferred
- Demonstrated ability to work accurately, follow instructions/schedules/timelines and handle multiple priorities
- Strong interpersonal skills and ability to work with others in a positive “can do” and collaborative manner
- Previous experience with statistical tools such as JMP is preferred
- Excellent customer facing capabilities
- Strong verbal and written communication skills 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.
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.