Senior Manager, Quality Control – External (San Carlos, CA)

Sutro Biopharma, Inc. is looking for an experienced, energic, and dynamic Senior Manager of Quality Control – External to manage Quality Control aspects for external GMP Operations.  The primary function will be to interface with CTOs, CMOs, and business partners to support and implement phase-appropriate QC methods validations and routine testing, specifications setting, product expiry dating, reference standard and critical reagent inventory management, SOPs and other document writing to support Sutro’s custom reagents, intermediates, and DS/DP manufactured externally.  The successful candidate will have technical understanding of both analytical and microbiological test methods, method transfers/validations, and data trending, as well as experience working within quality systems, compliance, and regulatory (global) requirements.  The ability to follow multiple projects along with strong verbal and written communication, time management, and critical thinking skills are essential.  This role directly interfaces with internal and external Quality Assurance, Analytical Development, Manufacturing Sciences and Technology (MSAT), and external manufacturing and business partners.

Responsibilities

• Collaborates with QC senior management and cross functional internal and external project teams to lead external QC activities, including:
  • Analytical method transfers
  • Analytical methods qualification/validation/verification
  • Stability study designs
  • Reference standard and critical reagent qualifications, bridging, and inventory management
  • Product specifications
  • Product expiry dating
• 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/or 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
• Collaborate with internal and external partners to align on tech transfer activities. 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

Qualifications

• BS or MS in Chemistry, Biochemistry, Pharmaceutical Sciences or related field
• 10+ years with BS or 8+ years with MS experience in QC working 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 effectively prioritize among multiple project workstreams
• Strong interpersonal skills and ability to work collaboratively with others with a positive “can do” attitude
• Previous experience with statistical tools such as JMP is preferred
• Excellent customer facing capabilities
• Strong verbal and written communication skills essential
• Flexibility to attend meetings with global partners, including Europe and China
• Ability to travel up to 20%

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 $160,000 – $175,000 (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.