The Opportunity:
We are looking for an accomplished Director of Drug Product Development to provide scientific and technical leadership across a portfolio of clinical-stage programs focused on developing innovative treatments for serious, rare diseases. Based in the New York metro area, this individual will play a critical role in advancing drug product candidates through formulation development, manufacturing optimization, clinical supply, and regulatory milestones. The successful candidate will collaborate with internal stakeholders and external manufacturing partners to establish efficient, scalable development strategies that support both immediate program objectives and long-term product development.
Key Areas of Responsibility
Drug Product Innovation & Development:
Establish and execute comprehensive drug product development plans for clinical-stage programs, encompassing formulation development, process optimization, manufacturing feasibility, and product lifecycle considerations. Guide the development of robust, scalable dosage forms and manufacturing processes suitable for clinical development and future commercialization. Identify technical and manufacturing risks, implement mitigation strategies, and proactively address challenges that could impact program execution.
Manufacturing & External Partnerships:
Direct technical activities supporting clinical trial material production, manufacturing scale-up, and technology transfers.
Identify, evaluate, select, and manage external development and manufacturing organizations, including CDMOs and CMOs.
Maintain oversight of external partners to ensure technical deliverables meet established quality standards, budgets, and development schedules.
Build strong working relationships with contract manufacturers, consultants, and scientific advisors to support successful program delivery.
Regulatory & CMC Development:
Provide drug product expertise to support overall Chemistry, Manufacturing, and Controls (CMC) strategies.
Prepare, review, and contribute to drug product sections of regulatory filings, including submissions, amendments, responses to health authority questions, and briefing packages.
Ensure development activities and technical documentation align with applicable regulatory expectations for IND-enabling and clinical-stage programs.
Cross-Functional Leadership:
Collaborate with Drug Substance, Analytical Development, Quality, Regulatory Affairs, Clinical Operations, and Supply Chain to coordinate technical activities and achieve program milestones.
Align drug product development plans with organizational priorities, project budgets, and clinical timelines.
Serve as the drug product technical representative in internal decision-making forums and meetings with external manufacturers, auditors, consultants, and development partners.
Provide scientific direction and technical recommendations to support critical development decisions.
Qualifications & Experience
Education & Industry Background:
Ph. D. in Pharmaceutical Sciences, Chemical Engineering, or a related Physical Science discipline with a minimum of 12 years of relevant pharmaceutical or biotechnology industry experience, or a master's degree with at least 15 years of experience in drug product development. Extensive hands-on experience directing drug product development and CMC activities for small molecule programs within a clinical-stage pharmaceutical or biotechnology setting.
Technical & Regulatory Expertise:
Proven ability to advance drug product programs through critical development milestones, including clinical supply manufacturing, process scale-up, technology transfer, and regulatory filings.
Comprehensive understanding of CMC regulatory standards and technical expectations for IND-enabling and clinical-stage development.
Demonstrated experience authoring drug product CMC sections for regulatory submissions.
Strong knowledge of formulation development, manufacturing processes, and technical challenges associated with clinical-stage drug products.
Experience overseeing external CDMOs, CMOs, and development partners while ensuring accountability for execution, quality, and timelines.
Broad understanding of the CMC development process, with demonstrated ability to collaborate across Drug Substance, Analytical Development, Quality, Regulatory, Supply Chain, and Clinical functions.
Leadership & Collaboration:
Strong technical leadership, sound judgment, and analytical problem-solving capabilities.
Exceptional written and verbal communication skills, with the ability to translate complex scientific and technical information for diverse audiences.
Ability to prioritize competing demands and deliver results in a dynamic, entrepreneurial organization with limited resources.
Demonstrated success establishing and maintaining productive relationships with external manufacturers, technical consultants, and scientific advisors.
Comfortable representing drug product development in cross-functional discussions and providing technical guidance on key program decisions.
Previous experience mentoring colleagues and fostering a collaborative, results-oriented, and accountable team environment is preferred.
