Manager, Quality Control (Stability And Critical Reagent Programs)

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, Antibody intermediate, and DS/DP programs. The role directly interfaces with internal and external Quality and Analytical Development teams.

Responsibilities:

• Collaborates with QC senior management and cross functional departments to design, implement, and oversee a compliant, inspection ready QC Stability and Critical Material program. Specific duties will require:
  • The development of stability protocols to evaluate long-term, accelerated, and stressed storage conditions for custom reagents, Antibody intermediates, drug linker, and DS/DP.
  • Support QC External function in the oversight of stability studies managed via CMO/CTOs – ensure the timely receipt and review and trending of stability data.
  • Manage the execution of all in-house stability – coordinate with QC to ensure all testing is executed within the acceptable stability timepoint windows.
• Optimize and standardize the Sutro Critical Material program to provide a holistic inventory management system for Sutro Custom reagents, Antibody Intermediates, and DS/DP programs.
• Manage critical material burn rate across all Sutro Sites and CMO/CTOs, working with QC External and Analytical Development teams to qualify new material.
• Collaborate with the Analytical Development and QC External teams to design and support stability programs.
• Collaborate with Quality Assurance to establish/extend product shelf-life for Sutro custom reagents, intermediates, and DS/DP
• Trend stability data for all programs and work with QC senior management to resolve all stability study discrepancies and 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.

Qualifications:

• 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.
• Knowledge in ICH/USP/EP/JP guidelines as it relates to QC methods, validation, and stability.
• Experience with statistical analysis as related to interpretation of stability, trending and material qualification data
• JMP and LIMs Experience 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.
• 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.

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 [$140,000-160,000] (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.

Sutro Biopharma, Inc., is a clinical-stage company relentlessly focused on the discovery and development of precisely designed cancer therapeutics, transforming what science can do for patients. Sutro’s fit-for-purpose technology, including cell-free XpressCF®, provides the opportunity for broader patient benefit and an improved patient experience. Sutro has multiple clinical-stage candidates, including luveltamab tazevibulin, or luvelta, a registrational-stage folate receptor alpha (FolRα)-targeting ADC in clinical studies. A robust pipeline, coupled with high-value collaborations and industry partnerships, validates our continuous product innovation. Sutro is headquartered in South San Francisco. For more information, follow Sutro on social media @Sutrobio, or visit www.sutrobio.com.