Director, CMC Product Development - Small Molecule

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. Work arrangement: hybrid, with a minimum of two (2) days on-site per week, currently Tuesday and Wednesday.

Responsibilities

Define and execute drug product development strategy for assigned small molecule programs, including formulation approach, manufacturing platform, and development roadmap; 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; 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 and other small molecule drug delivery systems; Serve as the primary technical interface with CDMO drug product teams, providing scientific oversight, document review, and deviation resolution; Author and review drug product sections of regulatory submissions (IND, IMPD, NDA, MAA) and lead the technical response to FDA and EMA questions; Integrate Quality by Design (QbD) and Design of Experiments (DoE) into formulation and process development, establishing CQAs, CPPs, and design spaces; Collaborate with Analytical Development to define drug product release and stability specifications, in-process controls, and comparability strategies; Lead packaging development and container-closure system selection, 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; Evaluate drug delivery technology options and novel dosage form strategies for pipeline candidates; Contribute to CMC due diligence assessments and portfolio planning; Perform other duties and responsibilities as assigned

Requirements

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; Experience managing cross-functional stakeholder relationships at the senior level, with the ability to influence without authority; 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; Organized and detail-oriented communicator who can manage competing priorities; Position may require ability to travel 20%+ as needed of time or more including occasional overnight stay

Benefits

Competitive health and wellness coverage (structure and premiums vary by country); Paid time off, public holidays, and additional leave entitlements in accordance with local requirements; Flexible work arrangements / hybrid schedule; Discretionary annual bonus and long-term incentive award (e.g., equity) may be available