Senior Director/Director, Formulation Development (Small Molecules)
New York City, NY
Position Summary:
We are with a leading Clinical Stage Biopharma who are seeking a Senior Director/Director of Formulation Development to lead all drug product development activities across a portfolio of small molecule programs. This individual will be responsible for developing and executing formulation strategies from preclinical development through commercialization, ensuring robust, scalable, and patient-centric drug products.
The successful candidate will serve as the formulation subject matter expert within the CMC organization and provide strategic leadership across preformulation, formulation development, process development, technology transfer, manufacturing, regulatory submissions, and lifecycle management activities. This role requires extensive collaboration with Process Chemistry, Analytical Development, Regulatory Affairs, Quality, Supply Chain, and external manufacturing partners.
Responsibilities:
Formulation Strategy & Leadership
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Lead formulation and drug product development strategies supporting small molecule programs from IND-enabling studies through registration and commercialization.
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Define phase-appropriate formulation approaches that balance clinical needs, manufacturability, regulatory expectations, and commercial considerations.
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Guide dosage form selection and product presentation strategies to support program objectives and future lifecycle opportunities.
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Develop integrated development plans, budgets, timelines, and risk mitigation strategies for drug product activities.
Drug Product Development & Manufacturing
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Provide strategic and technical leadership across preformulation, formulation development, process development, scale-up, technology transfer, and GMP manufacturing.
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Oversee development of oral solid dosage forms, including tablets, capsules, immediate-release, modified-release, and enabling formulations.
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Drive formulation approaches for challenging compounds with solubility, bioavailability, stability, or manufacturability limitations.
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Establish and maintain robust control strategies, specifications, and critical quality attributes aligned with regulatory expectations.
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Support process validation, registration batches, and commercial launch readiness activities.
External Partner & CDMO Management
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Lead selection, oversight, and governance of CDMOs, CROs, and external development partners.
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Serve as the primary technical interface for outsourced drug product development and manufacturing activities.
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Ensure external partners meet established quality, timeline, cost, and supply objectives.
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Drive issue resolution, technical investigations, and risk mitigation strategies across partner networks.
Regulatory & Technical Support
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Author, review, and approve CMC sections related to drug product development for INDs, IMPDs, CTAs, NDAs, and global regulatory submissions.
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Support interactions with regulatory agencies and contribute to responses for health authority questions.
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Ensure compliance with FDA, EMA, ICH, and other applicable global regulatory requirements.
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Provide technical leadership during inspections, audits, and due diligence activities.
Cross-Functional Collaboration
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Partner closely with Process Chemistry, Analytical Development, Regulatory Affairs, Quality Assurance, Supply Chain, Clinical Operations, and Commercial teams.
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Serve as the formulation representative on cross-functional development teams and governance committees.
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Communicate program progress, key risks, and development recommendations to senior leadership.
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Support integrated CMC planning and execution across multiple development programs.
Organizational Leadership
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Mentor and develop formulation scientists within the organization.
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Foster a culture of scientific excellence, innovation, collaboration, and accountability.
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Contribute to broader CMC organization strategy, capability development, and continuous improvement initiatives.
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Support resource planning, budget forecasting, and portfolio prioritization activities.
Education, Experience & Qualifications:
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Ph.D. or M.S. in Pharmaceutics, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related scientific discipline.
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12+ years (Director) or 15+ years (Senior Director) of experience within the pharmaceutical or biotechnology industry.
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Significant experience leading formulation and drug product development for small molecule programs.
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Demonstrated experience advancing compounds from preclinical or Phase I development through late-stage clinical development and commercialization.
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Deep understanding of oral solid dosage formulation development, pharmaceutical manufacturing, scale-up, and commercialization.
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Strong knowledge of biopharmaceutics principles, dissolution, bioavailability enhancement technologies, and product performance characterization.
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Experience managing external CDMOs and development partners within an outsourced operating model.
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Proven track record supporting successful IND, NDA, and global regulatory submissions.
