Associate Director of Drug Product
About the Company
A clinical-stage biotechnology company is advancing a pipeline of innovative small molecule therapeutics for serious diseases with significant unmet medical needs. The organization is focused on translating scientific innovation into impactful therapies and is committed to advancing development programs from early research through commercialization.
Position Overview
We are seeking an experienced Associate Director, Drug Product Development to lead formulation and drug product development activities across multiple small molecule programs. This position will play a key role in advancing candidates from preclinical and clinical development through registration and commercial readiness.
The successful candidate will possess strong expertise in pharmaceutical development, solid oral dosage forms, and manufacturing sciences, along with experience leading external development and manufacturing partners. This individual will collaborate closely with multidisciplinary teams to support CMC strategy and execution across the product lifecycle.
Key Responsibilities
- Lead drug product development strategy for assigned small molecule development programs.
- Direct formulation development, process development, scale-up, and technology transfer activities.
- Design and oversee development of phase-appropriate clinical formulations aligned with program objectives and timelines.
- Author, review, and approve CMC documentation, including development reports, manufacturing records, and regulatory submission content.
- Manage external development and manufacturing organizations to ensure quality, compliance, technical excellence, and timely execution.
- Partner with internal functions including process development, analytical development, regulatory affairs, quality, supply chain, and project management.
- Collaborate cross-functionally with non-CMC stakeholders supporting clinical and development programs.
- Provide technical leadership for investigations, troubleshooting efforts, risk assessments, and change management activities.
- Ensure compliance with applicable GMP regulations, ICH guidelines, and global regulatory standards.
- Support manufacturing campaigns and development activities through periodic travel as needed.
Education & Qualifications
- Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related discipline with significant industry experience in pharmaceutical development; or
- M.S. degree in a relevant scientific field with extensive pharmaceutical industry experience.
Required Experience & Skills
- Demonstrated experience in drug product development across multiple stages of clinical development, including late-stage and commercial readiness activities.
- Strong knowledge of formulation development, process optimization, manufacturing scale-up, and technology transfer.
- Experience managing outsourced development and manufacturing programs through CDMOs or other external partners.
- Understanding of critical quality attributes (CQAs) and their impact during scale-up and process changes.
- Experience supporting regulatory submissions and health authority interactions.
- Excellent leadership, communication, project management, and problem-solving skills.
- Ability to effectively influence and collaborate across multidisciplinary teams.
Preferred Qualifications
- Experience supporting Phase 2, Phase 3, validation, registration, or commercial manufacturing programs.
- Knowledge of Quality by Design (QbD), Design of Experiments (DoE), and risk-based development approaches.
- Experience in complex pharmaceutical product development and lifecycle management.
- Familiarity with compounds presenting formulation and bioavailability challenges.
Why Join
- Opportunity to contribute to the advancement of innovative therapies with the potential to improve patient outcomes.
- Fully remote structure, can be based anywhere in the United States.
- Collaborative, science-driven environment with significant visibility and impact.
- Ability to influence development strategy across multiple programs and stages of development.
- Competitive compensation, benefits, and long-term incentive opportunities.
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