The Opportunity:

We are seeking an advanced career scientist with a passion for process chemistry. You will be a hands-on experimentalist leading scientific investigations, coordinating cross-disciplinary decisions, and solving critical problems affecting process transfer and clinical supply. You will own complex drug substance development work.  The role requires experience working in support of regulatory filings, and a record of solving problems, and exercising sound technical judgment in complex and ambiguous development situations.

• Personally design and execute pivotal experiments to resolve difficult chemistry problems, develop new methods, and test high-impact scientific hypotheses.

• Lead investigations of complex reaction behavior, process variability, and impurity formation; establish scientifically justified recommendations for process control.

• Direct integrated process development across assigned programs or complex workstreams, establishing technical priorities and evaluating alternative development strategies.

• Manage a small group of scientists and research associates, developing technical capability through clear objectives, rigorous data review, coaching, and performance feedback.

• Lead cross-disciplinary technical discussions and decisions with analytical development, quality, manufacturing, regulatory, and supply chain partners.

• Direct laboratory scale-up and technology transfer to CDMOs, evaluate implementation risks, and lead resolution of significant manufacturing problems.

• Author and review process chemistry documentation and scientific justifications in support of regulatory filings, ensuring that development evidence supports the proposed manufacturing process.

• Identify broader implications of experimental findings for subsequent development, influence project strategy, and maintain strong standards of laboratory safety and knowledge capture.

Required Skills, Experience and Education:

• PhD in organic chemistry and at least 8 years of related experience, which may include postdoctoral research, with substantial pharmaceutical industry process development experience.

• A record of solving complex and ambiguous small-molecule process chemistry problems and delivering robust processes for clinical manufacturing.

• Direct experience contributing to regulatory submissions and leading process development, scale-up, and technology transfer activities.

• Advanced hands-on synthesis, experimental design, mechanistic reasoning, impurity investigation, and interpretation of analytical evidence.

• Demonstrated leadership of cross-disciplinary scientific work and experience supervising scientific staff and developing direct reports.

• Strong understanding of cGMP manufacturing, drug substance control strategies, process safety, and development needs from early through later stages.

• Ability to make and communicate consequential technical recommendations, balance competing project needs, and remain active in the laboratory.

Preferred Skills:

• Experience supporting multiple IND submissions or progressing drug substance processes through successive clinical development stages.

• Experience developing novel process solutions, leading significant manufacturing investigations, or contributing to scientific publications or intellectual property.

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