Head of Drug Product Development

Job Title: Head of Drug Product Development

Work Location: Suffolk County, Massachusetts

Summary:

Oversee all aspects of Chemistry, Manufacturing, and Controls (CMC) drug product development from early to late-stage clinical development and commercialization. This includes developing scalable manufacturing processes, managing technology transfer, clinical supply manufacturing, and supply chain oversight. The role also involves preparation and review of CMC regulatory filings and leading multifunctional teams and external partners to support clinical trials and product development.

Responsibilities:

• Direct internal and external teams to advance drug product development, ensuring alignment with project goals and technical operations strategies.
• Promote innovative, cross-functional collaboration and leverage external expertise to achieve operational objectives.
• Drive planning and execution of product development activities from early clinical phases through commercialization, proactively identifying and mitigating risks.
• Facilitate effective communication with internal stakeholders and external partners to ensure seamless project progression and supply chain management.
• Establish and manage budgets for drug product development, maintaining financial accountability for all related activities.
• Oversee timelines and technical planning for external manufacturing partners, ensuring clinical and development needs are met.
• Supervise teams responsible for clinical trial supplies, ensuring timely inventory management and delivery of investigational products.
• Apply advanced formulation and manufacturing principles to develop optimal, phase-appropriate drug product formulations and ensure regulatory compliance in documentation and submissions.

Qualifications:

• PhD in pharmaceutical sciences, chemical or biochemical engineering, chemistry, or related field with at least 15 years of industry experience and 10 years in senior CMC/formulation leadership roles, especially with injectables.
• Expertise in injectable drug products, particularly vials (liquid and lyophilized), and synthetic peptide formulations.
• Proven leadership of drug product teams through Phase 3, process validation, launch readiness, and commercial transition.
• Experience in early phase (pre-clinical, Phase 1) development is a plus.
• Demonstrated background in drug-device combination product development, including fill-finish processes and compatibility evaluations.
• Experience with clinical studies, supply chain management, and global CDMO oversight is highly desirable.
• Comprehensive knowledge of CMC, including process/formulation development, analytical science, regulatory, and quality requirements.
• Strong leadership, communication, and collaboration skills, with experience working in global and cross-functional teams.
• Experience managing development and manufacturing at global CDMOs and with synthetic peptide manufacturing and packaging.
• Working knowledge of material characterization and delivery technologies for synthetic peptides.
• Excellent data analysis, problem-solving, and project management skills, with the ability to communicate complex issues clearly.
• Thorough understanding of ICH, FDA, EMEA, and USP guidelines and their application throughout product development stages.
• Experience with regulatory submissions and agency interactions for CMC and drug-device combination products.
• Ability to work independently and in matrix teams, influencing cross-functional improvements and team performance.
• Strong interpersonal, communication, and innovative problem-solving abilities.

Published Category: Manufacturing & Technical Operations