Senior Scientist I

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.
• Serve on cross-functional project teams and collaborate 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.