--- title: 'Associate Director, Quality Control at Rezolute' canonical: 'https://feeny.ai/job/associate-director-quality-control-rezolute-redwood-city-tz9eapa6hazd' type: 'job' last_seen: '2026-11-06' --- # Associate Director, Quality Control at Rezolute - **Company:** Rezolute - **Location:** Redwood City, CA - **Employment:** full-time - **Work type:** onsite - **Posted:** 2025-09-03 - **Last confirmed live:** 2026-11-06 - **Apply:** https://jobs.lever.co/rezolutebio/824fad73-afb8-4a87-a55a-7f98fbfaaf31 ## Job description Rezolute is a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism (HI). Our antibody therapy, RZ358 (ersodetug), is designed to treat all forms of HI and has shown substantial benefit in clinical trials and real-world use for the treatment of congenital hyperinsulinism (cHI) and tumor hyperinsulinism (tHI) Position Description This position is responsible for management of Rezolute’s clinical and commercial product testing program. The Associate Director, Quality Control acts as a liaison between Rezolute and its contract test laboratory (CTL) / CMO partners who perform our release and stability testing.  The successful candidate will support Rezolute’s objectives by acting as a Quality Control subject matter expert during internal stakeholder collaborations and external team meetings. Principle Duties and Responsibilities Include: Manage data review program - Review raw data and data summaries provided by contract testing facilities - Provide timely feedback to testing laboratories regarding necessary corrections to raw data and summaries - Perform electronic data entry and verification Manage reference standard and critical reagent program - Maintain inventory of reference standards and critical reagents at contract testing facilities - Manage the qualification and requalification of new reference standards and critical reagents Manage analytical method lifecycle - Design and maintain the analytical method monitoring program - Recommend improvements to existing test methods - Manage the transfer of test methods to contract laboratories including review and approval of protocols and reports - Participate in the development and validation of new test methods Initiate and review Quality System records - Review deviations, OOS/OOT investigations, supplier change notices and change control records as Quality Control subject matter expert - Author, review and revise Quality Control SOPs - Manage submission of Quality Control documents into electronic document management system Support regulatory filings - Participate in the preparation of regulatory documents (e.g., IND, IMPD, BLA, NDA, MAA) and requests for information including data verification of content - Participate in the preparation of Annual Product Quality Reviews including data verification of content - Other duties as assigned - Qualifications/Requirements: - Bachelor’s degree in biology, chemistry, biochemistry, microbiology, or related field - 6+ years in pharmaceutical/biopharmaceutical Quality Control / Analytical Science environment; experience with biologics preferred - Detailed knowledge of analytical techniques and compendial methods used for testing of proteins and small molecules - Proficiency in GMP analytical data review - Demonstrated understanding of laboratory investigation methodology for OOT and OOS results - Demonstrated knowledge of GMP principles and regulatory guidance - Competent technical writer with expertise in authoring method protocols and reports as well as SOPs and Quality System records (deviations, investigations, change controls) - Prior use of a LIMS application or electronic database - Proficient with Microsoft Applications (Word, Excel, Outlook, SharePoint, Teams, etc.) - Data-driven mindset with eye for detail - Robust problem-solving abilities - Capable of maintaining direction while working independently - Ability to identify and adapt to changing priorities: determine what matters most - Ability to articulate issues to management in a timely manner - Self-motivated: ability to interact with a multi-disciplinary remote-based team - Effective written and verbal communication skills Preferred Experience, Special Skills and Knowledge: - Previous partnership with external contract laboratory to coordinate activities between sponsor and service provider - Prior author of regulatory submissions of IND, IMPD, BLA, NDA, MAA - Previous contribution to annual product quality review (APQR) process Rezolute (RZLT) currently anticipates the base salary for the Associate Director Quality Control   role could range from $185,000 to $200,000 and will depend, in part, on the successful candidate’s geographical location and their qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company’s discretion on an individual basis). The compensation described above is subject to change and could be higher or lower than the range described based on current market survey data and the qualifications, education, experience and geographical location of the selected candidate. Qualifying employees are eligible to participate in benefit programs such as: - Health Insurance (Medical / Dental / Vision) - Disability, Life & Long-Term Care Insurance - Holiday Pay - Tracking Free Vacation Program - 401(k) Plan Match - Educational Assistance Benefit - Fitness Center Reimbursement We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. ## About Rezolute ## Company Overview - **One-liner**: Rezolute is a late-stage rare disease biotechnology company developing ersodetug, a monoclonal antibody therapy for hypoglycemia caused by congenital and tumor hyperinsulinism. - **Entity Type**: Public (Nasdaq: RZLT) - **Headquarters**: Redwood City, California, United States (with an additional office in Louisville) - **Founded**: Not publicly available (IPO 2012) - **Founders**: Not publicly available ## Core Business - **Primary industry**: Biotechnology – rare disease therapeutics - **Target customers**: B2B – healthcare providers, patients, and payers; focuses on addressing severe unmet medical needs in hyperinsulinism - **Mission/purpose**: Significantly improve outcomes for individuals with hypoglycemia caused by hyperinsulinism ([rezolutebio.com – About](https://rezolutebio.com/job-openings/)) ## Products & Services - **Ersodetug (lead candidate)**: An intravenously administered human monoclonal antibody that allosterically binds to the insulin receptor, down‑modulating insulin action to restore normal glucose levels. Being developed for two indications: - **Congenital Hyperinsulinism (sunRIZE Phase 3 study)** – completed enrollment (May 2025) with 62 participants; topline results expected December 2025. - **Tumor Hyperinsulinism (upLIFT Phase 3 study)** – initiated mid‑2025; FDA agreed to a single‑arm open‑label design; topline results expected second half 2026. - Designations: Orphan Drug (US/EU), Rare Pediatric Disease, Breakthrough Therapy (US), PRIME (EU), ILAP (UK) ([ir.rezolutebio.com – 10-K](https://ir.rezolutebio.com/sec-filings/content/0001104659-25-090848/0001104659-25-090848.pdf)) ## Market Standing - **Valuation/Market Cap**: $317.7 million (as of recent data, per LinkedIn) ([linkedin.com](https://linkedin.com/company/rezolute)) - **Key Metric (Public)**: Annual revenue of $14.1 million (likely from grants or collaboration revenue; no product revenue yet) ([linkedin.com](https://linkedin.com/company/rezolute)) - **Notable Investors/Partners**: Not publicly available – company is publicly traded and does not disclose a lead investor list. Key partners include clinical trial sites and regulatory agencies (FDA, EMA). - **Growth Signals**: - Headcount: 50 employees (+2.9% YoY) ([linkedin.com](https://linkedin.com/company/rezolute)) - Phase 3 sunRIZE study fully enrolled; topline data pending December 2025. - Phase 3 upLIFT study enrolling with streamlined design; data expected second half 2026. - FDA granted Breakthrough Therapy Designation for tumor HI in May 2025. - Multiple regulatory designations accelerating development pathway. ## Competitive Advantages - **Unique mechanism**: Ersodetug acts downstream from beta cells at the insulin receptor, allowing it to potentially treat all forms of hyperinsulinism (genetic or acquired) regardless of underlying cause. - **Dosing convenience**: Half‑life >2 weeks enables monthly intravenous administration. - **Regulatory momentum**: Orphan Drug, Rare Pediatric Disease, Breakthrough Therapy, PRIME, and ILAP designations provide expedited review, potential priority review voucher, and closer FDA/EMA collaboration. - **Pivotal data catalysts**: Two Phase 3 studies read out within ~12‑18 months, creating clear value inflection points. ## Strategic Focus - Execute the two ongoing Phase 3 trials (sunRIZE in congenital HI, upLIFT in tumor HI). - Assuming positive topline data from sunRIZE, submit a Biologics License Application (BLA) to the FDA for ersodetug in mid‑2026. - Continue to build commercial and medical affairs infrastructure (recent job postings indicate hires in Commercial Operations, Marketing, Payer Strategy, and Supply Chain) ([rezolutebio.com – Job Openings](https://rezolutebio.com/job-openings/)). ## Why Work Here - **Mission‑driven**: Employees work on therapies for ultra‑rare, life‑threatening conditions with high unmet medical need. - **Benefits**: Comprehensive health/dental/vision insurance, competitive salaries, annual bonus, 401(k) with company match, tuition assistance, on‑site meals, flexible spending accounts ([rezolutebio.com – Benefits](https://rezolutebio.com/job-openings/)). - **Work environment**: Hybrid/office policy not explicitly stated; roles are based in Redwood City (HQ) and Louisville. Recent openings include remote-friendly functions? Not confirmed. - **Growth opportunity**: Small company (~50 people) entering late‑stage development and pre‑commercial build‑out – employees can have broad impact and career advancement. - **Engineering culture**: For biotech, the focus is on clinical operations, regulatory, and commercial roles rather than traditional engineering. IT positions (Business System Engineer) exist. ## Sources 1. [linkedin.com – Rezolute company page](https://linkedin.com/company/rezolute) 2. [rezolutebio.com – Job Openings & Benefits](https://rezolutebio.com/job-openings/) 3. [ir.rezolutebio.com – SEC 10-K Filing (September 2025)](https://ir.rezolutebio.com/sec-filings/content/0001104659-25-090848/0001104659-25-090848.pdf) 4. [rezolutebio.com – Leadership page](https://rezolutebio.com/leadership/) ## Other roles at Rezolute - [Director – Biostatistics](https://feeny.ai/job/director-biostatistics-rezolute-redwood-city-rsdg74z82vkk) — Redwood City, CA - [Medical Science Liaison / Senior Medical Science Liaison - Oncology / Rare Endocrine Disorders](https://feeny.ai/job/medical-science-liaison-senior-medical-science-liaison-oncology-rare-endocrine-bhs2782j7gtm) - [Medical Science Liaison / Senior Medical Science Liaison - Pediatric Endocrinology / Rare Metabolic Disorders](https://feeny.ai/job/medical-science-liaison-senior-medical-science-liaison-pediatric-endocrinology-pvkvqb4szfae) - [Recruiting Coordinator & Scheduler – 6 month contract](https://feeny.ai/job/recruiting-coordinator-scheduler-6-month-contract-rezolute-redwood-city-x0gcanx9q7vf) — Redwood City, CA - [Contract Recruiter (Biopharmaceutical Industry) 6 month contract](https://feeny.ai/job/contract-recruiter-biopharmaceutical-industry-6-month-contract-rezolute-redwood-jvpc3bn5g8t2) — Redwood City, CA - [Senior Manager, Scientific Communications & Medical Education](https://feeny.ai/job/senior-manager-scientific-communications-medical-education-rezolute-redwood-city-363wemxkxap1) — Redwood City, CA - [Head of Product Launch Program Management (Rare Disease)](https://feeny.ai/job/head-of-product-launch-program-management-rare-disease-rezolute-redwood-city-7qka6sahvk1h) — Redwood City, CA - [Associate Director, Medical Affairs Operations](https://feeny.ai/job/associate-director-medical-affairs-operations-rezolute-redwood-city-gg2p7j75sszn) — Redwood City, CA - [Vice President, Global Manufacturing](https://feeny.ai/job/vice-president-global-manufacturing-rezolute-redwood-city-wcyqhfyet1yw) — Redwood City, CA - [Vice President, Global Supply Chain](https://feeny.ai/job/vice-president-global-supply-chain-rezolute-redwood-city-q0dngx787mdk) — Redwood City, CA