Manager, Quality Control – Stability and Critical Reagent Programs (San Carlos, CA)
Sutro Biopharma, Inc. is seeking an energetic, talented, and adaptable Manager of Quality Control (Stability and Critical Reagent Programs) who will work within a dynamic team environment to support GMP operations. Primary function will be to develop and maintain stability studies and critical reagent programs including protocol development and data monitoring, in support of custom reagent and antibody intermediate’s programs. The role directly interfaces with internal and external Quality Assurance and Analytical Development teams.
- Collaborates with QC senior management and cross functional departments to design, implement, and oversee a compliant, inspection ready QC stability and standard program. Specific duties will require:
- The development of stability protocols to evaluate long-term, accelerated, and stressed storage conditions for custom reagents and antibody intermediates.
- Overseeing the execution of all stability protocols managed via our CMO partners – ensure the timely receipt and review of all stability data. Ensure internally and externally generated stability data is trended in a timely manner.
- Managing the execution of all in-house stability – coordinate with QC to ensure all testing is executed within the acceptable stability timepoint windows.
- Collaborate with the Analytical Development group to design and support stability and critical reagent programs.
- Collaborate with Quality Assurance to establish/extend product shelf-life.
- Trend all stability data and work with QC senior management to resolve all stability failures. Lead investigation of stability OOS and OOT results.
- Provide support during inspection and regulatory audits with emphasis on stability data and critical reagent programs.
- Draft and review QC-stability and critical reagent documents (SOPs, Protocols, Reports etc).
- Collaborate with external partners and RA to provide stability data in support of regulatory filings and annual reports.
- Develop and Maintain reference standard programs for each of platform products.
- Prepares accurate stability summary reports for annual reports, with periodic updates to leadership or external partners in support of shelf-life extension.
The ideal candidate for this position will have demonstrable in-depth knowledge and understanding of the development and implementation of Stability and Reference material programs.
- BS in Biology, Chemistry, or related field.
- 8+ years of Quality Control-stability experience in the biopharma or pharmaceutical industry. A solid understanding of the QC testing and the requirements to establish a robust stability and critical reagent program.
- Understand current GMPs with a familiarity of ICH, FDA, USP, and EMA (Ph Eur) guidelines as applicable to stability testing and the establishment/extension of product shelf-life.
- Experience with statistical analysis as related to interpretation of stability data.
Sound exciting? Apply today and join our team!
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.
Please be advised, inquiries or resumes from recruiters will not be accepted.
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.