Associate Director, CMC Product Development - Small Molecule

Requirements

• Education: Ph.D. in Pharmaceutical Sciences, Pharmaceutics, Chemical Engineering, or a closely related discipline preferred, or equivalent industry experience in pharmaceutical analytical development.
• 7+ years of pharmaceutical drug product development experience focused on small molecules in pharmaceutical or biotechnology industry
• Demonstrated track record of serving as the primary scientific lead on

Additional Information

About Beeline Medicines: Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients - realizing a world where people with immune-mediated diseases can live life fully. Job Summary: The Associate Director, CMC Product Development - Small Molecule is a senior pharmaceutical scientist and individual contributor responsible for formulation development, drug product process development, and manufacture of clinical supplies in support of small molecule drug candidates. Reporting to the Executive Director, CMC Product Development, this individual is the primary technical owner for drug product development activities on assigned programs, driving work from early formulation screening through Phase 3 and registration. This role carries no direct reports but serves as the key scientific interface with CDMO drug product partners and cross-functional CMC teams. It requires hands-on expertise in small molecule formulation science and manufacturing, direct CDMO technical management experience, and the ability to deliver high-quality CMC outcomes independently in a pre-commercial biotech environment. Work Arrangement & Location: Hybrid - This position follows a hybrid work schedule, requiring a minimum of two (2) days on-site per week - currently designated as Tuesday and Wednesday . Additional on-site days may be required based on business needs, team priorities, or leadership direction. Essential Duties and Responsibilities: Lead formulation development activities for small molecule drug candidates across all clinical phases, including excipient screening, compatibility studies, formulation optimization, and selection of final drug product composition for clinical and commercial manufacturing. Oversee drug product process development and scale-up for solid oral dosage forms (tablets, capsules) and other small molecule delivery formats, including process characterization, manufacturing process optimization, and tech transfer to CDMO sites. Serve as the primary technical interface with CDMO drug product teams for assigned programs, providing day-to-day scientific oversight of formulation and manufacturing campaigns, batch record review, and deviation resolution. Author and contribute to drug product sections of regulatory submissions (IND, IMPD, NDA) including formulation descriptions, manufacturing process narratives, container-closure justifications, and drug product control strategies. Integrate Quality by Design (QbD) principles and Design of Experiments (DoE) into formulation and process development decisions, establishing critical quality attributes (CQAs), critical process parameters (CPPs), and design spaces. Oversee drug product stability programs in collaboration with Analytical Development, including protocol design, shelf-life determination, and stability data interpretation in support of regulatory submissions and label claims. Support packaging development and container-closure system selection for clinical drug product presentations, including compatibility assessment, extractables/leachable considerations, and child-resistant packaging requirements. Contribute to clinical supply planning by providing manufacturing timelines, batch size projections, and drug product release schedules to the Clinical Supply Chain function in support of trial startup and enrollment milestones. Evaluate drug delivery technology options and novel dosage form strategies for pipeline candidates, providing formulation feasibility assessments and manufacturability input during candidate selection and early development planning. Operate as a self-directed pharmaceutical sciences contributor - independently managing formulation study plans, CDMO deliverable timelines, and CMC documentation while keeping cross-functional teams and leadership aligned on program status, risks, and decisions. Perform other duties and responsibilities as assigned

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at Beeline Medicines? Share your experience