Opportunity OverviewAs Director, Drug Product - Formulation, you will lead the global strategy and execution of oral drug product development across all phases, from early development through commercialization and lifecycle management. This role is responsible for building robust, scalable formulation and manufacturing capabilities, advancing phase-appropriate formulations, and ensuring successful regulatory submissions and product launches. You will work cross-functionally and with external partners to deliver high-quality oral solid dosage products aligned with target product profiles and business objectives.
Responsibilities and Duties- Lead the global oral drug product strategy and operating model to deliver scalable, phase-appropriate oral solid dosage formulations across the pipeline and lifecycle.
- Oversee drug product design and development from pre-formulation through clinical and commercial readiness, including dosage form selection, excipient strategy, and manufacturability.
- Develop robust formulations and control strategies using Quality by Design (QbD) principles, including identification of CQAs, CPPs, and lifecycle management plans.
- Direct process development, scale-up, and manufacturing of oral dosage forms (e.g., blending, granulation, compression, coating, encapsulation, spray drying, hot-melt extrusion), including support for innovative technologies where applicable.
- Lead technology transfer activities to internal manufacturing sites and CDMOs, ensuring successful process validation, PPQ execution, and commercial readiness.
- Ensure high-quality CMC deliverables for global regulatory submissions (IND, CTA, NDA, MAA), including authorship, review, and responses to health authority queries.
- Establish platform formulation strategies (e.g., enabling formulations, modified release, pediatric/geriatric, neo-natal approaches) to enhance efficiency and reduce development timelines.
- Manage relationships with CMOs/CDMOs, including technical oversight, performance management, governance, and supply risk mitigation.
- Partner cross-functionally with Analytical, Drug Substance, Regulatory CMC, Quality (GxP/GSQ), Supply Chain, and Commercial teams to ensure alignment from development through launch.
- Support early-stage development by enabling rapid formulation approaches (e.g., on-site compounding, clinical trial materials) and assessing developability of new chemical entities.
- Drive scientific evaluation and interpretation of data, author technical reports, and contribute to regulatory documentation and inspection readiness activities.
- Build and lead a high-performing team, fostering talent development, innovation, compliance, and continuous improvement.
Qualifications and Skills- Advanced degree (PhD or MS) in Pharmaceutical Sciences, Chemical Engineering, Chemistry, Materials Science, or related discipline.
- Minimum of 10 years of experience in drug product development and manufacturing within the pharmaceutical or biotechnology industry, including leadership experience.
Technical Expertise- Deep expertise in oral solid dosage form development (tablets, capsules) and enabling formulation technologies (e.g., amorphous dispersions, solubility/permeability enhancement strategies, lipid-based systems).
- Strong understanding of pre-formulation and biopharmaceutics principles, including dissolution, supersaturation, precipitation, and food effect considerations.
- Experience in developing BCS Class II/IV drugs.
- Demonstrated experience in process development, scale-up, and manufacturing science, including control strategies and process robustness.
- Proven success in technology transfer to CDMOs/internal sites and execution of process validation/PPQ.
- Experience with stability programs, packaging/container closure systems, shipment studies and shelf-life determination.
- Direct experience in parenteral drug product formulation development a plus
Regulatory & Compliance- Strong knowledge of global GMP requirements and regulatory expectations.
- Experience authoring and reviewing CMC sections for regulatory submissions (IND, NDA, MAA) in alignment with ICH guidelines (Q8, Q9, Q10).
- Demonstrated ability to support inspections and regulatory interactions.
Leadership & Collaboration- Experience managing external partners (CSPs/CDMOs) and cross-functional teams in a matrixed environment.
- Strong project leadership skills with the ability to align resources and priorities across multiple programs.
- Excellent written and verbal communication skills, with the ability to translate complex technical information for diverse stakeholders.
- Hands-on, resourceful, and effective in lean or rapidly evolving environments.
This role is based out of our corporate office in Boston, Massachusetts. Rhythm operates in a hybrid-work model. Candidates applying must be willing and able to be in the Boston office in coordination with their department and business needs. This role may involve some travel.
The expected salary range for this position is $182,000 - $275,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and company performance. This role may be eligible for benefits and other compensation such as restricted stock units.
