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Associate Director of Drug Product Development

Formation BioNew York, NY; Boston, MA
On-site Full-time $177K/yr - $235K/yr

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Experience Level

Senior Level Manager

Qualifications

To excel in this role, candidates should possess:A strong background in pharmaceutical sciences or related fields. Extensive experience in CMC activities related to drug product development, particularly with sterile injectables. Demonstrated ability to effectively collaborate with CDMOs and manage external partnerships. Excellent problem-solving skills and a track record of successfully navigating complex manufacturing challenges. Strong communication skills to convey technical information clearly to diverse stakeholders.

About the job

About Formation Bio

Formation Bio is a technology and AI-driven pharmaceutical company dedicated to transforming drug development through unprecedented efficiency.

As advancements in AI and drug discovery lead to an influx of potential drug candidates, the pharmaceutical industry faces a bottleneck due to the prohibitive costs and lengthy timelines associated with clinical trials. Founded in 2016 as TrialSpark Inc., Formation Bio has developed innovative technology platforms, processes, and capabilities aimed at expediting all facets of drug development and clinical trials. By partnering with, acquiring, or in-licensing drugs from pharmaceutical companies, research organizations, and biotech firms, we advance programs beyond clinical proof of concept, ultimately facilitating the delivery of new treatments to patients. Our investor backing includes notable names in both pharma and technology such as a16z, Sequoia, Sanofi, Thrive Capital, Sam Altman, John Doerr, Spark Capital, SV Angel Growth, and others.

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At Formation Bio, our core values propel our mission to innovate the pharmaceutical landscape. Every team member embodies these values, contributing significantly to our goal of delivering new treatments to patients more rapidly and effectively.

About the Position

The Associate Director of Drug Product Development will offer strategic and hands-on leadership for all CMC activities associated with drug product development and manufacturing, primarily focusing on sterile injectables (both lyophilized and liquid) throughout all development phases, from IND-enabling studies to commercialization.

This role entails overseeing formulation development, fill-finish processes, packaging, and the release of drug products at Contract Development and Manufacturing Organizations (CDMOs), ensuring that manufacturing operations meet program timelines, quality standards, and regulatory requirements. A deep understanding of biologics drug product manufacturing, robust technical problem-solving skills, and proven experience managing complex manufacturing operations with external partners are essential. Your contributions will be pivotal in accelerating our efforts to bring innovative therapies to market.

About Formation Bio

Formation Bio is at the forefront of revolutionizing drug development through advanced AI technologies. Our mission is to overcome traditional barriers in the pharmaceutical industry, ensuring that new medicines reach patients more efficiently. With a robust backing from leading investors, we are committed to pioneering innovative solutions in drug development.

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