Cullinan Oncology · 2 days ago

Director, Biologics CMC Drug Product

United States

Full-time

Remote

Director/Executive

10+ years exp

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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 manufacturing

Develop, lead, 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

Drive 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.

Qualification

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Pharmaceutical SciencesChemical EngineeringDrug Product DevelopmentManufacturing for Therapeutic ProteinsProtein Formulation DevelopmentCMC Regulatory Sections GenerationVendor ManagementFill-Finish Process EngineeringAdministration/Delivery KnowledgeCGMP Requirements FamiliarityFDA Guidelines KnowledgeEU Guidelines KnowledgeICH Guidelines KnowledgeProgram ManagementMultidisciplinary CollaborationLeadership Qualities

Required

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.