Director, Drug Product and Process Development

Otsuka Pharmaceutical Companies (U.S.)

. Lead the strategic and technical aspects of solid oral dosage products manufactured at CDMOs .

Posted 11/3/2026full-timeRemote • United StatesLead💰 $186,489 - $278,875 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in leading formulation and process development for solid oral dosage forms, ensuring compliance with GMP and global regulatory standards while managing cross-functional teams and driving continuous improvement initiatives.

Highest-signal resume keywords

Pharmaceutical Development LeadershipGMP Compliance ExpertiseFormulation Development for Solid Oral Dosage FormsProject Management in BiopharmaceuticalsRegulatory Submissions and Approvals

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Formulation DevelopmentProcess DevelopmentScale-Up TechniquesProcess ValidationTechnology TransferAnalytical Problem-SolvingProject Budget ManagementProduct Lifecycle ManagementDosage Form DevelopmentCMC Drug Development

Soft Skills

Strong LeadershipEffective CommunicationInterpersonal SkillsCollaborationAdaptability

Tools & Technologies

Production EquipmentProcess AnalyticsQuality Assurance SystemsRegulatory Compliance Tools

Industry Keywords

Biopharmaceutical IndustryGMPFDAICHEMEAWHOSolid Oral Dosage FormsImmediate-Release FormulationsModified-Release FormulationsLong-Acting Injectables

About the role

Key responsibilities & impact

Lead the strategic and technical aspects of solid oral dosage products manufactured at CDMOs
Lead formulation development, process development, scale-up, process validation/process performance qualification, and technology transfer
Provide day-to-day support for GMP manufacture of drug products at external CDMOs
Establish and maintain business and technical relationships with CDMOs and internal functional groups
Lead the design, development, and technology transfer of manufacturing processes
Oversee the CMC drug development process from preclinical to clinical stages
Ensure project teams comply with GMP, US and global regulatory requirements, and industry standards
Lead and mentor scientists, researchers, and engineers
Drive formulation development, process optimization, scale-up, and technology transfer activities
Drive continuous improvement initiatives and implement best practices
Collaborate with quality assurance and regulatory teams to support technology transfer, scale-up, and commercialization
Guide team members and maintain expertise in production equipment and dosage-form manufacturing
Author, review, and approve development plans, protocols, reports, and regulatory submissions
Report to the Executive Director, CMC & Product Development

Requirements

What you’ll need

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
Experience leading and managing CMC pharmaceutical development teams
Experience driving development and commercialization of pharmaceutical products
Ability to prioritize and manage multiple projects simultaneously
Ability to meet deadlines and adapt to changing priorities in a dynamic environment
Strong leadership, communication, and interpersonal skills
Ability to influence and collaborate effectively with internal and external stakeholders
Excellent analytical and problem-solving abilities
Ability to make informed decisions based on scientific, technical, and business considerations
Knowledge of managing project budgets
Experience managing pharmaceutics and immediate- and modified-release formulation development for solid oral dosage forms or immediate- and extended-release parenteral dosage forms, including injectables, infusions, implants, and long-acting injectables
Experience with product lifecycle management and process analytics
Expertise in state-of-the-art production equipment and dosage form development
Knowledge of GMP and US and global regulatory requirements, including FDA, ICH, EMEA, and WHO
Ability to travel 10–40%

Benefits

Comp & perks

Comprehensive medical, dental, vision, and prescription drug coverage
Company-provided basic life insurance
Accidental death and dismemberment insurance
Short-term and long-term disability insurance
Tuition reimbursement
Student loan assistance
Generous 401(k) match
Flexible time off
Paid holidays
Paid leave programs
Other company-provided benefits
Incentive opportunity