Cullinan Therapeutics, Inc.?(Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients.
We have strategically built a diversified portfolio of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in both oncology and autoimmune disease. Our portfolio encompasses a wide range of modalities, each with the potential to be best and/or first in class.
Anchored in a deep understanding of oncology, immunology, and translational medicine, we create differentiated ideas, identify the most appropriate targets, and select the optimal modality to develop transformative therapeutics across a wide variety of cancer and autoimmune indications.
We push conventional boundaries from candidate selection to differentiated therapeutic, applying rigorous go/no go criteria at each stage of development to fast-track only the most promising molecules to the clinic and, ultimately, commercialization.
With deep scientific expertise, our teams exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients.
Summary: The Director, Drug Product Manufacturing position is a key, high impact role responsible for biologics drug product development and manufacturing from preclinical through early and late (pivotal) clinical development to commercialization for a broad pipeline of products. The Director, Drug Product Manufacturing will be a member of the CMC team (within Technical Operations), reporting to the Executive Director, Drug Product Manufacturing. This role provides the opportunity to build Cullinan's 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 via a network of external providers.
\n Position Responsibilities:Lead and oversee biologics drug product technical development including formulation, process, and administration/delivery throughout program's lifecycle (preclinical through commercialization)Lead biologics drug product process technical transfer to CMOs and provide oversight during manufacturingDevelop, lead, and manage external drug product development and manufacturing capabilities and network Ensure compliance with FDA, cGMPs, and ICH guidelinesAuthor and review technical documents and regulatory filings; support associated agency interactions and product-related inspectionsDrive 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 Candidate Requirements:Ph.D. or Master's degree in Pharmaceutical Sciences, Chemical Engineering or relevant field Minimum 10+ years of relevant experience in biotech/pharma industry, with a focus on drug product development and manufacturing for therapeutic protein productsExtensive hands-on 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 formatsProven 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 influence, 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. Leadership qualities of the successful candidate include the following: collaboration, accountability, stakeholder management, cross-functional engagement and influence, program management, strategic vision, executive presence.
\nCullinan Therapeutics is proud to be an Equal Opportunity Employer. We are committed to creating an inclusive and diverse environment for all employees and applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.