Job Summary:

The Director, CMC Product Development – Small Molecule is a senior technical and operational leader responsible for the end-to-end CMC development of small molecule drug product candidates, from early formulation through process development, clinical supplies, and regulatory submission. Reporting to the Executive Director, CMC Product Development, this individual drives the drug product development activities on assigned programs. This role carries no direct reports but works cross-functionally with internal teams and external CDMO drug product partners. It requires deep expertise in small molecule formulation science and manufacturing, experience in taking programs through late-stage development and filing, and ability to make sound technical decisions 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:

• Define and execute drug product development strategy for assigned small molecule programs, including formulation approach, manufacturing platform, and the development roadmap required to support the clinical and regulatory plan.
• 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.
• Direct and oversee drug product process development, technical transfer, scale-up, process optimization, registration batch execution, and process validation / PPQ for solid oral dosage forms (tablets, capsules) and other small molecule drug delivery systems.
• Serve as the primary technical interface with CDMO drug product teams for assigned programs, defining the scope of activities, providing scientific oversight of formulation and manufacturing campaigns, document review, and deviation resolution. Hold partners accountable to quality and timeline commitments.
• Author and review drug product sections of regulatory submissions (IND, IMPD, NDA, MAA) including formulation descriptions, manufacturing process narratives, container-closure justifications, control strategies and process validation approaches. Lead the technical response to FDA and EMA questions on drug product topics and support health authority meetings.
• 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.
• Collaboration with Analytical Development to define drug product release and stability specification, in-process controls, and comparability strategies for formulation and process changes.
• Lead packaging development and container-closure system selection for clinical and commercial drug product presentations, including compatibility assessment, 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, enrollment milestones and uninterrupted clinical supply.
• 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.
• Contribute to CMC due diligence assessments and portfolio planning by evaluating the manufacturability and development feasibility of small molecule drug product candidates.
• 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.
• 10+ years of pharmaceutical drug product development and manufacturing 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 from early to late clinical phases.
• Deep technical expertise in solid oral dosage form development (immediate release, modified release, amorphous solid dispersions), including formulation selection, manufacturing process development, scale up, technical transfer, commercial process optimization, and validation.
• Proven experience in selecting and managing external partner relationships (CDMOs and contract laboratories), including technical oversight, work order management, change control, deviation resolution, and performance monitoring.
• Comprehensive knowledge of ICH Q8/Q9/Q10/Q11, cGMP requirements and FDA/EMA drug product development expectations.
• 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 track record of operating effectively in a pre-commercial, resource-constrained environment — balancing strategic vision with hands-on execution and infrastructure building.
• Experience managing cross-functional stakeholder relationships at the senior level, with the ability to influence without authority and align diverse teams around shared program goals.
• Strong written and verbal communication skills, with a track record of authoring high-quality regulatory documents, scientific reports, and executive-level presentations.
• Effective collaborator with a track record of building productive working relationships across CMC functions, Clinical Development, Clinical Pharmacology, 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.
• Position may require ability to travel 20%+ as needed of time or more including occasional overnight stay driven by business need.