Director, Drug Product & Process Development; Molecules

Position: Director, Drug Product & Process Development (Small Molecules)
## Director, Drug Product & Process Development (Small Molecules)
Apply locations:
Remote time type:
Full time posted on:
Posted Yesterday job requisition :
R12442

The Director, Drug Product Development will lead
** late‐stage development and NDA‐enabling activities
** for
** oral solid dosage form (OSD)
** drug products. This role is responsible for execution of formulation, process development, scale‐up, validation, and regulatory deliverables to support NDA submission, regulatory review, and commercial launch. The Director will act as the
** Drug Product CMC lead
** for assigned late‐stage programs, working cross‐functionally and with external manufacturing partners to ensure robust, compliant, and inspection‐ready drug products.
** Key Responsibilities
**** Late‐Stage OSD Development & Execution
*** Lead late‐stage development of
** oral solid dosage forms** (e.g., IR, MR, XR and complex formulations).
* Finalize commercial formulations and manufacturing processes including blending, granulation, compression, coating, and encapsulation.
* Ensure drug product design is robust, scalable, and aligned with registration and commercial manufacturing requirements.
* Support scale‐up activities and ensure consistency between clinical, registration, and commercial processes.
* Conduct and document risk assessments for CQAs and CPPs; implement mitigation strategies as needed.
** NDA & Regulatory Submission Support
*** Lead execution of
** drug product CMC activities for NDA submission
** for assigned programs.
* Author, review, and approve NDA Module 3 sections related to oral solid dosage form development, manufacturing, and controls.
* Support responses to FDA and health authority information requests during NDA review.
* Participate in regulatory meetings and contribute to
** pre‐approval inspection (PAI) readiness
** activities.
* Ensure drug product development activities comply with FDA, ICH, and internal quality standards.
** Process Characterization, Validation & Tech Transfer
*** Lead or support process characterization studies and PPQ activities for OSD products.
* Support continued process verification planning in collaboration with Quality and Manufacturing.
* Execute technology transfer of oral solid dosage form processes to commercial manufacturing sites or CDMOs.
* Troubleshoot late‐stage manufacturing and scale‐up issues related to OSD unit operations.
** External Manufacturing & CDMO Management
*** Provide day‐to‐day technical oversight of CDMOs manufacturing oral solid dosage forms.
* Review development reports, batch records, and validation documentation from external partners.
* Work with Quality and Supply Chain to support launch readiness and reliable supply.
** Cross‐Functional Collaboration
*** Serve as the
** drug product CMC representative
** on late‐stage program teams.
* Collaborate closely with Drug Substance, Analytical Development, Regulatory Affairs, Quality, Manufacturing, and Program Management.
* Communicate development risks, timelines, and mitigation plans to functional and program leadership.
** People & Operational Leadership
*** Lead and mentor a small team of scientists and engineers supporting oral solid dosage form development.
* Provide technical guidance, performance feedback, and development coaching.
* Manage project‐level budgets, outsourcing activities, and timelines for assigned programs.
** Lifecycle & Post‐Approval Support
*** Support post‐approval change management activities including comparability assessments and CBE submissions.
* Contribute to continuous improvement initiatives focused on process robustness, manufacturability, and cost‐of‐goods.
* Provide ongoing technical support for commercial oral solid dosage form products as needed.
** Qualifications
* *** Education
* ** PhD or MS in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a related discipline.
** Experience
* ** 10–12+ years of experience in
** oral solid dosage form drug product and process development**.
* Demonstrated experience supporting
** late‐stage development and at least one NDA submission**.
* Experience supporting FDA inspections or PAI readiness for OSD manufacturing sites.
* Hands‐on experience working…