Director, Drug Product and Process Development

Otsuka Pharmaceutical Co., Ltd.

2d•$186,489 - $278,875

About The Position

The Director is an experienced pharmaceutical product-development leader who provides strategic and technical leadership for drug product development in a virtual environment. The role leads the development of solid oral dosage products at contract development and manufacturing organizations (CDMOs), while collaborating with internal and external partners—including manufacturing, supply chain, quality assurance, and regulatory teams—to deliver commercially viable products that meet high standards of quality and patient safety. The position reports to the Executive Director, CMC & Product Development. The Director oversees drug product CMC development from preclinical through clinical stages and leads formulation and process development, optimization, scale-up, process validation and performance qualification, technology transfer, and day-to-day GMP manufacturing support at external CDMOs. The role establishes and maintains strong business and technical relationships with CDMOs and internal functions, and ensures work complies with GMP, applicable US and global regulations, and industry standards. The Director leads and mentors scientists, researchers, and engineers; manages project budgets and multiple priorities; and drives continuous improvement and efficient, high-quality development practices. The role also supports technology transfer, scale-up, and commercialization in collaboration with quality assurance and regulatory teams. Relevant product experience includes immediate- and modified-release solid oral dosage forms, immediate- and extended-release parenteral dosage forms such as injectables, infusions, and implants, long-acting injectables, product life-cycle management, and process analytics. The Director maintains expertise in production equipment and dosage-form development and authors, reviews, and approves technical and regulatory documents. Travel may be 10–40%.

Requirements

BS or MS in Pharmaceutical Sciences, Organic Chemistry, Chemical Engineering, or a related field, and at least 15 years of biopharmaceutical industry experience; or a PhD in Pharmaceutics, Pharmaceutical Sciences, Organic Chemistry, Chemical Engineering, or a related field, and 10 or more years of biopharmaceutical industry experience working in drug product development.
Experience successfully leading and managing CMC pharmaceutical development teams and driving pharmaceutical product development and commercialization.
Ability to prioritize and manage multiple projects, meet deadlines, and adapt to changing priorities in a dynamic environment.
Strong leadership, communication, and interpersonal skills, with the ability to influence and collaborate with internal and external stakeholders.
Excellent analytical and problem-solving abilities, including making informed scientific, technical, and business decisions.

Responsibilities

Lead strategic and technical development of drug products manufactured at CDMOs.
Lead formulation development, process development and optimization, scale-up, process validation and process performance qualification, and technology transfer.
Provide day-to-day support for GMP drug product manufacturing at external CDMOs.
Establish and maintain robust business and technical relationships with CDMOs and internal functional groups.
Oversee CMC drug product development from preclinical through clinical stages and ensure compliance with GMP, US and global regulatory requirements, and industry standards.
Lead, mentor, and support the professional growth of scientists, researchers, and engineers.
Manage project budgets and multiple projects and priorities.
Drive continuous improvement and implement practices that improve development efficiency and quality.
Collaborate with quality assurance and regulatory teams to support technology transfer, scale-up, and commercialization.
Guide team members and maintain expertise in production equipment, dosage-form development, and regulatory compliance.
Author, review, and approve development plans, protocols, reports, and regulatory submissions.