What are the responsibilities and job description for the Associate Director/Director, CMC Operations and Strategy position at Ank Talent Solutions?
Title : Associate Director / Director, CMC Operations and Strategy
Reports to : Leadership team including CSO and CTO
About MarvelBiome :
MarvelBiome, Inc. is a biopharmaceutical company with a vision of harnessing the power of microbes for treating various human diseases. We are focused on isolating, identifying, and characterizing microbial populations for novel therapeutic applications. MarvelBiome thrives on a strong scientific foundation, proprietary screening platform, assay methods, and powerful host and bacterial genetic approach. The company is founded over years of advanced scientific research conducted by the cofounders at Massachusetts General Hospital / Harvard University, Boston, MA, including one cofounder who is a 2024 Nobel Prize winner.
After a successful phase 1 study, our lead drug candidate is expected to begin phase 2 clinical trials for neurodegenerative disease in mid-2025. Preclinical work is ongoing in multiple disease areas.
About the Job :
MarvelBiome is seeking a Director of CMC Operations and Strategy. The role will oversee a CDMO and play a key role in the successful operation and support of GMP manufacturing of MarvelBiome’s live biotherapeutics products. This position demands a deep understanding of tech transfer, manufacturing processes, quality compliance, regulatory compliance, and leadership skills to ensure the successful production of microbiome products through effective collaboration with external partners.
Responsibilities :
Serve as the subject matter expert for GMP manufacturing processes and equipment
Oversee and partner with the CDMO for GMP production
Develop and monitor tech transfer and manufacturing budgets, timelines, and resources to ensure the successful execution of manufacturing projects
Lend technical expertise for the specification and selection of production materials and equipment
Identify risks and develop mitigation plans
Identify and implement phase-appropriate processes and process improvements to enhance efficiency, quality, and scalability
Support the preparation of regulatory submissions and audits, including CMC sections of IND
Qualifications :
BS degree in a relevant life science discipline with at least 5 years of relevant industry experience, and 3 years of experience in a project management and / or leadership experience supporting / leading cross-functional teams in a scientific environment
5-10 years of hands-on experience with GMP manufacturing or process development, including 3 years in a supervisory role
Thorough understanding of all phases of biologic drug development, with specific experience in microbiome drug manufacturing
Experience overseeing and managing a CDMO for clinical-stage GMP manufacturing
Experience with regulatory submissions and knowledge of phase-appropriate CMC considerations
Excellent oral and written communication skills
Strong project management and organizational skills
Ability to work in fast-paced, start-up environment with shifting priorities