Director, Drug Product

The Opportunity:

The Director, Drug Product, will lead formulation and process development activities for small-molecule and biologic drug products within the Pharmaceutical Development & Manufacturing (PDM).

The role will oversee development of portfolio programs from candidate assessment, preformulation, and IND-enabling studies through clinical development, registration, technology transfer, process validation, commercialization, and lifecycle management.

Responsibilities include phase-appropriate dosage form and formulation selection, process development and scale-up, clinical supply manufacturing, primary packaging and delivery systems, control strategy development, regulatory support, and oversight of external development and manufacturing partners.

The role may have people-management responsibilities and will provide technical guidance across programs while partnering cross-functionally to deliver robust, scalable, patient-centered drug products that meet quality, regulatory, clinical, and commercial requirements.

Key Responsibilities

• Define and execute phase-appropriate drug product strategies for small-molecule and biologic programs across early- and late-stage development.

• Provide drug product input into candidate selection, developability assessment, pre-formulation, and dosage form selection.

• Lead formulation and process development for small-molecule and biologic drug products, including oral solid and liquid dosage forms, injectable liquids, and lyophilized products, and aseptic fill-finish processes for sterile products. Address relevant product risks such as solubility, bioavailability, manufacturability, and stability.

• Oversee clinical drug product manufacturing and supply from early clinical studies through pivotal trials and registration campaigns.

• Lead late-stage scale-up, process optimization, technology transfer, process validation, PPQ execution, commercial readiness, and lifecycle management activities.

• Establish quality target product profiles, critical quality attributes, critical material attributes, critical process parameters, specifications, and control strategies using QbD and risk-management principles.

• Select and manage CROs, CDMOs, and external manufacturing partners to meet quality, timeline, budget, and supply objectives.

• Author, review, and approve drug product sections of INDs, CTAs, IMPDs, NDAs, BLAs, MAAs, and responses to health authority questions.

• Partner cross-functionally with Drug Substance, Analytical Development and Quality Control, Clinical Supply, Quality, Regulatory Affairs, Supply Chain, and Program Management.

• Manage and coach drug product scientists and engineers.

Required Skills, Experience and Education:

• BS/MS/PhD in Pharmaceutical Sciences, Chemical or Biochemical Engineering, Chemistry, Biochemistry, Biophysics, or related scientific/engineering discipline.

• 8+ years of experience in drug product development and manufacturing across small molecules and biologics, with deep technical expertise in at least one modality and demonstrated ability to lead programs in the other.

• Experience spanning early development and late-stage development, including candidate assessment or IND-enabling work, clinical development, registration, process validation, and commercial readiness.

• Strong knowledge of small-molecule dosage form development and biologic formulation, aseptic fill-finish, primary packaging, scale-up, and technology transfer.

• Experience managing CROs, CDMOs, and external manufacturing partners across development and GMP manufacturing activities.

• Strong knowledge of cGMP, QbD, pharmaceutical risk management, process validation, and applicable FDA, EMA, and ICH requirements.

• Strong technical judgment, communication, collaboration, and problem-solving skills, with the ability to support multiple programs and influence cross-functional teams in a matrix organization.

#LI-CT1 #LI-Hybrid