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Senior Manager, Analytical Development & Quality Control

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

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Experience Level

Senior Level Manager

Qualifications

The ideal candidate will possess the following qualifications:Advanced degree in a relevant scientific field (PhD preferred)Extensive experience in analytical development and quality control within the pharmaceutical or biotech industryProven track record of managing vendor relationships effectivelyStrong understanding of both small molecule and biologics development processesExcellent communication and leadership abilitiesAbility to work collaboratively in a fast-paced, team-oriented environment

About the job

About Formation Bio

Formation Bio is a pioneering pharmaceutical company leveraging technology and artificial intelligence to transform drug development.

With the rise of AI in drug discovery, the pharmaceutical industry is facing an unprecedented influx of potential drug candidates. However, the high costs and lengthy timelines associated with clinical trials can hinder progress. To address this critical bottleneck, Formation Bio, established in 2016 as TrialSpark Inc., has developed advanced technology platforms and processes designed to expedite every facet of drug development and clinical trials. Our mission is to partner with, acquire, or in-license promising drugs from pharmaceutical companies, research institutions, and biotech firms, advancing them beyond clinical proof of concept to ultimately deliver new therapies to patients. Our company enjoys the backing of leading investors across both the pharmaceutical and tech sectors, including a16z, Sequoia, Sanofi, Thrive Capital, Sam Altman, John Doerr, Spark Capital, SV Angel Growth, and many others.

Explore more about us through the following links:

At Formation Bio, our core values drive our commitment to revolutionizing the pharmaceutical industry. Each member of our team shares these values and plays a crucial role in our goal to accelerate the availability of new treatments for patients.

About the Position

We are on the lookout for a highly motivated, self-driven, and detail-oriented Senior Manager/Associate Director of Analytical Development and Quality Control to become a vital part of our CMC team. This position offers a broad exposure across Formation Bio’s portfolio, demanding adaptability between small molecule and biologics programs at various development stages within an outsourced development framework. The successful candidate will possess a robust technical skillset, excel in vendor management, and demonstrate the ability to balance scientific rigor with program timelines.

In this pivotal role, you will provide technical leadership as a subject matter expert in the development, optimization, and validation of analytical methods for drug substances and drug products, supporting the outsourced development and manufacturing processes.

About Formation Bio

Formation Bio is an innovative pharmaceutical company dedicated to transforming drug development through advanced technology and AI. Our mission is to streamline the process of bringing new medicines to market, ensuring that patients receive timely access to groundbreaking therapies.

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