Director - Drug Product Manufacturing

October 30

Apply Now

Receive Emails with Similar Jobs

Cullinan Oncology

WebsiteLinkedInAll Job Openings

Oncology

11 - 50 employees

Founded 2018

🧬 Biotechnology

💊 Pharmaceuticals

💰 $10M Post-IPO Equity on 2022-03

Description

• 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. • 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.

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 products • Extensive 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 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 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.