[Hiring] Director, Drug Product and Process Development @Otsuka Pharmaceutical Co., Ltd.

Role Description

Director, Formulation Development is an experienced leader in the development of pharmaceutical products in a virtual environment with extensive technical, strategic and leadership expertise in guiding teams and driving results. Leveraging their deep technical proficiency and proven cross-functional collaboration, they will empower decision making while serving as a product development expert to all relevant internal and external functional representatives (CMOs, Manufacturing, Supply Chain, Quality Assurance, Regulatory, etc.) to deliver products that are commercially viable and that meet the highest standards of quality and safety for patients.

• Lead the strategic and technical aspects of solid oral dosage products manufactured at contract development and manufacturing organizations (CDMOs).
• Responsibilities include formulation development, process development, scale-up, process validation/process performance qualification, technology transfer, and providing day-to-day support for GMP manufacture of drug products at external CDMOs.
• Partner with CDMOs and internal functional groups to establish and maintain robust business and technical relationships related to the development and manufacturing of drug products.
• Oversee the entire CMC drug development process for drug products from preclinical to clinical stages, ensuring compliance with GMP and US and global regulatory requirements (FDA, ICH, EMEA, and WHO) and industry standards.
• Lead and mentor a team of scientists, researchers, and engineers, fostering a culture of excellence, collaboration, and professional growth.
• Drive the formulation development, process optimization, scale-up, and technology transfer activities to ensure efficient and effective development of drug products.
• Manage the budget for projects.
• Drive continuous improvement initiatives, identify opportunities to optimize development processes, and implement best practices to enhance efficiency and quality.
• Collaborate with the quality assurance and regulatory teams to support technology transfer, scale-up, and commercialization of pharmaceutical products.
• Maintain expertise in state-of-the-art production equipment, development of dosage forms, and regulatory compliance in all aspects of dosage form manufacturing.
• Author, review, and approve technical documents, including development plans, protocols, reports, and regulatory submissions.
• Position may involve travel from 10 - 40%.

Qualifications

• BS or MS in Pharmaceutical Sciences, Organic Chemistry, Chemical Engineering, or related field with a minimum of 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.

Requirements

• Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
• Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
• Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
• Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
• Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
• Empowered Development - Play an active role in professional development as a business imperative.

Benefits

• Comprehensive medical, dental, vision, prescription drug coverage.
• Company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance.
• Tuition reimbursement and student loan assistance.
• A generous 401(k) match.
• Flexible time off, paid holidays, and paid leave programs.
• Other company provided benefits.