About Us

Infinimmune® is a venture-backed biotechnology company pioneering truly human antibody drug discovery and development. With a robust pipeline of differentiated monoclonal antibody programs in and approaching CMC and clinical development, we are building the foundational infrastructure, including quality systems and oversight, to bring these therapies to patients.

The Role

As our first dedicated quality leader, you will build a phase-appropriate quality system from the ground up and provide QA oversight of GMP manufacturing at our CDMO partners. Reporting to the Chief Technology Officer, you will set strategy as well as be a hands-on contributor, partnering closely with CMC, Regulatory, and Clinical Operations. This role is in-person at our Alameda, CA headquarters.

Want to work with us but this job description isn't a fit for you? Not a problem, we'd love to hear from you! E-mail us at careers@infinimmune.com.

Key Responsibilities

• Establish and maintain a phase-appropriate Quality Management System: SOPs, document control, training, deviations, CAPA, and change control.
• Provide QA oversight of drug substance and drug product manufacturing at CDMOs, including review of master and executed batch records, deviations, investigations, supply chain, and change controls.
• Own internal batch disposition and release of clinical supply, including support for US-based and ex-US clinical trials.
• Negotiate and maintain quality agreements; qualify and audit CDMOs, testing labs, and other GxP vendors.
• Oversee QA review of analytical methods, specifications, stability programs, and CoAs.
• Support IND and international clinical trial filings with quality input, and lead inspection or diligence readiness.
• Provide QA support for GxP activities as programs move into the clinic.
• Grow the quality function as the company and pipeline scale.

Qualifications

Required

• BS in a life science or related field.
• 10+ years in biopharma QA, including leadership experience.
• Direct experience with biologics, specifically mammalian-expressed monoclonal antibodies, in early clinical development.
• Strong working knowledge of 21 CFR 210/211, EU GMP and Annex 13, and ICH Q7/Q9/Q10.
• Proven track record of managing CDMOs in an outsourced model, including batch record review and disposition.
• Experience building or scaling a QMS at a small company.
• Sound, phase-appropriate judgment, with clear communication skills and a pragmatic, collaborative style.

Preferred

• MS/PhD in a life science or related field.
• Experience with TGA submissions and regulatory requirements in Australia and New Zealand.
• Experience managing quality across multiple concurrent CDMO and manufacturing relationships.
• Comfort operating as an individual contributor in a small team.

Base Salary Range: $150,000–$350,000 USD

At Infinimmune, you’ll be a true partner in our mission. Every compensation package we craft includes a strong equity component, ensuring every team member shares in our success as we build better drugs for humans, from humans.

Join us!

Infinimmune is a venture-backed biotechnology company intent on changing the way antibody discovery is done. We offer competitive salary, meaningful equity packages, matched 401(k), dedicated learning and development opportunities, company-provided lunch, and comprehensive medical, vision, and dental benefits for full-time employees and their dependents. Infinimmune’s headquarters are located in Alameda, CA, with a purpose-built modern lab and office space close to major population centers of the beautiful San Francisco Bay Area. Learn more about us at www.infinimmune.com.

Where you’ll work

Infinimmune is located on Bay Farm Island in the San Francisco Bay Area, 2.5 miles from Oakland International Airport, 1.5 miles from the Ferry Terminal (a 20 minute ferry ride from Embarcadero or South SF) and 5 miles from BART (which has dedicated shuttle service to our HQ). The bicycle route from BART is largely via a bike path along the shore with a beautiful view. We are about 10 minutes by car from downtown Alameda and ≤ 45 minutes by car from most locations in the Bay. There is also ample free parking at our site and subsidized EV charging. We also fully fund transit vouchers and provide secure bike parking. This role is expected to be on-site five days a week.

Some legal reminders

Infinimmune is an equal opportunity employer and will consider all applicants for employment. Infinimmune does not discriminate based on race, sex, color, religion, age, national origin, marital status, disability, veteran status, genetic information, sexual orientation, gender identity or any other reason prohibited by law in provision of employment opportunities and benefits.

For recruiting agencies

Infinimmune does not accept unsolicited applicants submitted by third-party recruiters or agencies. Any resume or application submitted to Infinimmune without a vendor agreement in place will be considered unsolicited and property of Infinimmune, and Infinimmune will not pay a placement fee.