Associate Director, Biologics CMC Drug Product

Cullinan Therapeutics

4d•$160,000 - $200,000•Remote

About The Position

Cullinan Therapeutics (NASDAQ: CGEM) is a clinical-stage biotech company developing potential first- or best-in-class, high-impact molecules in autoimmune diseases and cancer, where exceptional scientific expertise, strategic risk-taking, and rigorous decision-making unite to improve peoplesâ lives. We believe in a future where those living with autoimmune diseases and cancer spend less time managing their conditions and more time on what matters most. With deep expertise in immune modulation, Cullinan is where speed meets strategy to move profound innovations forward. But movement isnât just about speed â itâs about meaning. Our work is fueled by curiosity, determination, and compassion. We work side by side with our partners across the life science ecosystem to channel our collective potential into improving the lives of people living with autoimmune diseases and cancer. The Associate Director, Biologics CMC Drug Product Development position is a key role responsible for conducting drug product development and manufacturing from preclinical through early and late (pivotal) clinical development to commercialization for a pipeline of novel biologics products. The Associate Director, Biologics CMC Drug Product will be a member of the CMC team (within Technical Operations), reporting to the Executive Director, Biologics CMC Drug Product. This role provides the opportunity to contribute to Cullinanâs biologics drug product capabilities and involves close collaboration with various teams including process development, analytical sciences, supply chain, quality, regulatory, research, clinical, finance, and legal. The execution of all development, manufacturing, and testing for Cullinan Therapeutics is entirely via a network of external providers.

Requirements

Ph.D. or Masterâs degree in Pharmaceutical Sciences, Chemical Engineering or relevant field.
Minimum 8+ years of relevant experience in biotech/pharma industry, with a focus on drug product development and manufacturing for therapeutic protein products.
Extensive handsâon experience and in-depth knowledge and understanding of protein formulation development, fill-finish process engineering, and administration/delivery, with working knowledge of non-monoclonal antibody formats.
Proven ability to manage global, external vendors for development, manufacturing, and testing is essential.
Proven experience in the generation of CMC regulatory sections of IND, IMPD, BLA, and MAA filings. Extensive familiarity with phase-appropriate cGMP requirements and FDA, EU, and ICH guidelines.
Previous success working effectively in a multidisciplinary, highly matrixed environment with ability to collaborate and drive for results.
Excellent decision-making, written and verbal communication skills.
Motivated self-starter with excellent interpersonal and organizational skills. Strong self-awareness of the impact communication and working style has on others.
Qualities of the successful candidate include the following: collaboration, accountability, cross-functional engagement, and program management.

Responsibilities

Develop biologics drug product formulations, processes, and administration/delivery methods throughout programâs lifecycle (preclinical through commercialization).
Contribute to and manage biologics drug product process technical transfer to CMOs and provide oversight during manufacturing.
Develop and manage external drug product development and manufacturing capabilities and network.
Ensure compliance with FDA, cGMPs, and ICH guidelines.
Author and review technical documents and regulatory filings; support associated agency interactions and product-related inspections.
Support development and implementation of new process technologies to meet business and portfolio needs.
Remain current on trends and new technology advancements across the biopharmaceutical industry.