Senior Director, Drug Product & Process Development

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

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 is seeking a Director of Formulation Development to lead the strategic and technical development of solid oral dosage products manufactured at CDMOs. You will guide technology transfer, process development, scale-up, and GMP manufacturing support across CDMOs and internal teams.

The role requires senior leadership in CMC development, strong collaboration with QA and regulatory, and a track record of delivering commercially viable products while ensuring quality and

Qualifications

• BS or MS in Pharmaceutical Sciences, Organic Chemistry, Chemical Engineering, or related field with a minimum 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 formulation development, process development, scale-up and technology transfer for solid oral dosage forms.
• Oversee GMP manufacturing support with CDMOs and internal teams.
• Manage budget and drive continuous improvement in development processes.
• Collaborate with QA and regulatory to support tech transfer and commercialization.
• Guide team members and maintain expertise in production equipment and dosage form development.

Skills

Leadership

Strategic thinking

Communication

Problem solving

Cross-functional 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 is seeking a Director of Formulation Development to lead the strategic and technical development of solid oral dosage products manufactured at CDMOs. You will guide technology transfer, process development, scale-up, and GMP manufacturing support across CDMOs and internal teams.

The role requires senior leadership in CMC development, strong collaboration with QA and regulatory, and a track record of delivering commercially viable products while ensuring quality and