We are seeking a highly skilled and motivated Senior Scientist with expertise in small molecule synthesis and process development. The ideal candidate is an innovative thinker with a passion for problem-solving and an ability to drive the development of robust chemical processes from conception of the idea to commercialization. The candidate will play a key role in advancing our drug development programs by leading efforts in synthetic route design, process optimization, and scale-up and manufacturing activities. This position offers an exciting opportunity to contribute to the development of novel therapeutics and to work in a dynamic and collaborative research environment.

Responsibilities:

• Design and execute robust and scalable manufacturing routes and processes for small molecule drug substance production, considering safety, quality, and regulatory requirements
• Apply modern synthetic methodologies and techniques to optimize reaction sequences for improved yield, purity, and scalability
• Support design and execution of process characterization and fate/purge studies to establish critical process parameters and define process control strategies
• Leverage internal laboratory capabilities to generate key data and establish proof-of-concept for process development activities
• Collaborate with CDMO partners on development and manufacturing activities including tech transfer, process development, and scale-up from laboratory to pilot plant and ultimately to commercial production
• Characterize process streams, input materials, isolated intermediates, and final products using a variety of analytical techniques, such as HPLC, LC-MS, and NMR to support process R&D activities.
• Maintain accurate and detailed laboratory records in compliance with company policies and regulatory guidelines
• Prepare technical development reports and support authoring of clinical regulatory filings and responses to Health Authority inquiries (e.g., IND, IMPD) as needed
• Collaborate and serve on cross functional project teams with team members from Analytical Development, Formulation Development, and External Manufacturing to develop and execute a CMC strategy that aligns with the clinical development plan
• Collaborate effectively with colleagues from various disciplines including Medicinal Chemistry, Pharmacology, and Regulatory Affairs to achieve project goals
• Provide technical guidance to junior scientists and research associates
• Present research findings and project updates to internal stakeholders and external partners as required

Qualifications:

• Ph.D. in Organic Chemistry (or related field) with 5+ years of biotech/biopharma industry experience in small molecule drug substance development; or M.S. with 8+ years of relevant experience
• Strong expertise in synthetic organic chemistry, including multi-step synthesis and reaction optimization
• Experience in process development, scale-up, and technology transfer of small molecule APIs from laboratory to manufacturing scale
• Proficiency in analytical techniques commonly used in drug substance characterization
• Familiarity with cGMP regulations and quality systems relevant to pharmaceutical development
• Excellent problem-solving skills, attention to detail, and the ability to work independently and in a team-oriented environment
• Effective communication skills with the ability to convey complex scientific concepts to diverse audiences