Director / Senior Director, Chemistry, Manufacturing & Controls (CMC)

Director / Senior Director, Chemistry, Manufacturing & Controls (CMC) at Infinimmune Director / Senior Director, Chemistry, Manufacturing & Controls (CMC) at Infinimmune in Piedmont, California Posted in about 2 hours ago.

Type:

full-time

Job Description:

About Us Infinimmune® is a venture-backed biotechnology company pioneering truly human antibody drug discovery and development. Our Anthrobody® platform sources safe and effective antibodies from humans. With a robust pipeline of differentiated monoclonal antibody programs in and approaching CMC development, we are building the foundational infrastructure to bring these therapies to patients. Our drug products are designed for high-concentration, subcutaneous delivery - requiring deep expertise in formulation, device integration, and the unique process and analytical challenges that come with it. We are seeking a collaborative, hands-on Head of CMC to lead and build our CMC function at a critical inflection point in the company's growth. The Role Reporting to the Chief Technology Officer, the Head of CMC will serve as the senior leader responsible for Chemistry, Manufacturing, and Controls technical operations and contract manufacturer management across our growing therapeutic antibody pipeline. This individual will define and execute CMC strategy from early development through IND-enabling activities and into the clinic, working cross-functionally with discovery, preclinical development, regulatory, and clinical teams, both full-time and consulting. This role is in-person at our Alameda, CA headquarters. Key Responsibilities Define and own the CMC development strategy across multiple antibody programs simultaneously, aligning timelines and resources with corporate milestones Manage and oversee external CDMOs, CROs, and contract analytical labs Establish CMC policies, SOPs, and quality systems appropriate for a growing biotech Serve as key technical contributor to CMC scope of work and quality plan agreements with CDMOs Serve as the CMC subject matter expert on the leadership team, contributing to pipeline decisions, board presentations, and investor/partner communications Oversee cell line development, upstream bioprocess development, and downstream purification strategies for IgG-based antibody therapeutics Lead formulation development for high-concentration antibody drug products (?150 mg/mL) intended for subcutaneous administration Oversee DS and DP stability plan development, with input and approval from QA/QC Recruit and manage quality, regulatory, and other consultants as necessary Manage device selection, compatibility studies, and human factor considerations for syringe or autoinjectors in partnership with vendors Direct the development and qualification of analytical methods for drug substance and drug product, including stability-indicating assays Ensure all CMC activities are conducted in accordance with GxP expectations appropriate to development stage Review source documents from CDMOs, review and approve ATMs and MDRs; author and review CMC sections of INDs and related regulatory submissions; serve as primary CMC contact with regulatory agencies Qualifications Required Ph.D. in Chemical Engineering, Biochemistry, Pharmaceutical Sciences, or a related field; or

M.S./B.S.

with commensurate industry experience 12+ years of experience in biopharmaceutical CMC development, with a strong focus on monoclonal antibodies or related molecules Demonstrated experience developing high-concentration antibody formulations for subcutaneous delivery Significant experience managing CDMO relationships and overseeing GMP manufacturing campaigns Hands-on experience with successful IND filings and regulatory interactions as CMC lead Comfortable operating as the sole CMC expert in a small company, making judgment calls without complete data, and working with senior leadership. Preferred Experience with autoimmune or inflammatory disease indications Familiarity with combination product regulatory frameworks (21 CFR Part 3, FDA

CDER/CDRH

coordination) Prior experience building a CMC function at an early-stage biotech Existing relationships with high-quality CDMO and analytical CRO partners

Base Salary Range:

$180,000-$250,000 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. 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.