Director, Drug Product & Process Development (CMC)

Otsuka Pharmaceutical Co., Ltd; United States; Remote; USD 186,000 - 279,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Prescription drug coverage

Life insurance

AD&D insurance

Disability insurance

Tuition reimbursement

Student loan assistance

401(k) match

Flexible time off

Paid holidays

Paid leave

Job summary

Otsuka Pharmaceutical Co., Ltd seeks a Director of Formulation Development to lead strategic and technical activities for solid oral dosage products with external CDMOs, ensuring GMP compliance and regulatory readiness across preclinical to clinical stages.

The role requires strong leadership to mentor scientists and engineers, and to drive transfer of manufacturing processes, technology, and development documentation.

Qualifications

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

Responsibilities

• Lead the strategic and technical aspects of solid oral dosage products manufactured at CDMOs, including formulation development and process transfer.
• Partner with CDMOs and internal groups to establish robust relationships for development and manufacturing of drug products.
• Oversee CMC drug development from preclinical to clinical stages, ensuring GMP and regulatory compliance (FDA/ICH/EMEA/WHO).
• Lead and mentor a team of scientists, researchers, and engineers to foster excellence and growth.
• Drive process optimization, scale-up, and technology transfer to ensure efficient development of drug products.
• Manage budgets for projects and drive continuous improvement in development processes.

Skills

Leadership

Strategic thinking

Problem solving

Communication

Collaboration

Education

BS/MS in Pharmaceutical Sciences/Organic Chemistry/Chemical Engineering

PhD in Pharmaceutics/Pharmaceutical Sciences/Organic Chemistry/Chemical Engineering

Job description

Otsuka Pharmaceutical Co., Ltd seeks a Director of Formulation Development to lead strategic and technical activities for solid oral dosage products with external CDMOs, ensuring GMP compliance and regulatory readiness across preclinical to clinical stages.

The role requires strong leadership to mentor scientists and engineers, and to drive transfer of manufacturing processes, technology, and development documentation.