Director, Drug Product and Process Development

Otsuka; United States; Remote; USD 186,000 - 279,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) match

Tuition reimbursement

Paid holidays and leave

Job summary

Otsuka is seeking a Director of Formulation Development to lead development, manufacturing, and commercialization efforts for solid oral dosage products at CDMOs in a highly collaborative, global setting.

You will guide cross‑functional teams, ensure GMP compliance, and drive technology transfer, scale‑up, and process validation from preclinical through clinical stages, while managing budgets and mentoring junior staff.

Qualifications

• Broad leadership of late-stage pharmaceutical development programs.
• Experience leading and mentoring CMC teams and external partners (CDMOs).
• Strong collaboration with QA, Regulatory, and manufacturing groups.

Responsibilities

• Lead strategic and technical aspects of solid oral dosage products manufactured at CDMOs.
• Drive formulation development, process development, scale‑up, and technology transfer.
• Oversee GMP manufacturing support and ensure regulatory compliance (FDA, ICH, EMEA, WHO).
• Manage budgets for projects and drive continuous improvement in development processes.
• Mentor scientists, researchers, and engineers to foster excellence and collaboration.

Skills

CMC leadership

Cross-functional collaboration

Budget management

Technology transfer

GMP knowledge

Education

BS/MS in Pharmaceutical Sciences, Organic Chemistry, Chemical Engineering, or related field

PhD in Pharmaceutics, Pharmaceutical Sciences, Organic Chemistry, Chemical Engineering, or related field

Job description

Job Description Summary

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.

Responsibilities

In addition, the role requires a successful track record of carrying out development, manufacturing, and commercialization activities including a demonstrated ability to work effectively with CDMOs. The position reports to Executive Director, CMC & Product Development. You will be responsible for leading 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. You will 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. The Director will be responsible for leading the design, development and technology transfer of manufacturing processes, as well as managing day to day support for GMP manufacturing. Oversee the entire CMC drug development process for drug products from preclinical to clinical stages, ensuring self and project teams are acting in 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. The Director should be knowledgeable in managing 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. The Director should be experienced in managing pharmaceutics, immediate and modified release formulation development for solid oral dosage forms or immediate and extended‑release parenteral dosage forms, including injectables, infusions, and implants, long acting injectables, product life cycle management, and process analytics. You will be responsible for guiding team members, and for maintaining expertise in state‑of‑the‑art production equipment, development of dosage forms, and maintaining regulatory compliance in all aspects of dosage form manufacturing. Author, review, and approve technical documents, including development plans, protocols, reports, and regulatory submissions.

Travel: The position may involve travel from 10 - 40%.

Qualifications / Required Education / Knowledge / Experience and Skills

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.

Competencies

• 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.

Pay

Minimum $186,489.00 - Maximum $278,875.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

Application Deadline

Application Deadline: This will be posted for a minimum of 5 business days.

Company Benefits

Come discover more about Otsuka and our benefit offerings; https://ah-prod.com/multi/videoplayer/player.html?v=6385356920112. Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short‑term and long‑term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

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Disclaimer

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position.

Equal Opportunity Employer

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting EEAccommodations@otsuka‑us.com.

Agency Policy

Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre‑existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Company Culture and Statistics

Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: “Otsuka–people creating new products for better health worldwide.” In the U.S., Otsuka is comprised of two companies, Otsuka America Pharmaceutical, Inc., and Otsuka Pharmaceutical Development & Commercialization, Inc., that share a deep commitment to the development and commercialization of innovative products in the spaces of neuroscience, nephrology, and digital medicine. Driven by our purpose to defy limitation, so that others can too, we have an unwavering belief in doing more and transcending expectations. In going above and beyond—under any circumstances—for patients, families, providers, and for each other. It’s this deep‑rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day. OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Company, Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 34,400 people worldwide and had consolidated sales of approximately USD 14.2 billion in 2023.

Opportunity

We invite you to explore our open positions for an opportunity to join our 2,200 colleagues in the U.S. whose passion for our mission and pride in our company have earned us certification as a Great Place to Work by the Great Place to Work Institute.