Associate Director

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

Qualifications:

• 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 formulation and drug product process development programs across multiple clinical phases.
• Deep expertise in solid oral dosage form development (immediate release, modified release, amorphous dispersions), including excipient selection, compatibility, and manufacturing process development for tablets and capsules.
• Experience authoring drug product sections of INDs, IMPDs, and NDA filings and contributing to FDA or EMA responses on formulation, manufacturing, and drug product control strategy topics.
• Proven ability to operate as a high-impact individual contributor in a pre-commercial, resource-constrained environment — executing against multiple program deliverables simultaneously, operating with scientific independence, and contributing to the build-out of functional infrastructure and processes.
• Skilled in managing external partner relationships including CDMOs and contract laboratories, with hands-on experience in technical oversight, work order management, change control, deviation resolution, and performance monitoring at the working level.
• Strong written and verbal communication skills, with the ability to clearly present scientific data, development recommendations, and program updates to senior leadership and cross-functional partners.
• Effective collaborator with a track record of building productive working relationships across CMC functions, Clinical Development, Regulatory Affairs, and Quality in a team-oriented environment.
• Organized and detail-oriented communicator who can manage competing priorities, proactively flag risks, and keep cross-functional stakeholders aligned on timelines and deliverable status.