Director, Drug Product and Process Development

🔥 13 hours ago

🇺🇸 United States – Remote

💵 $186.5k - $278.9k / year

⏰ Full Time

🔴 Lead

👔 Director

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Otsuka Pharmaceutical Companies (U.S.)

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

Pharmaceuticals • Healthcare • Biotechnology

Otsuka Pharmaceutical Companies (U. S. ) is a prominent player in the pharmaceutical manufacturing industry, dedicated to creating innovative products for better health worldwide. The company comprises two main entities: Otsuka America Pharmaceutical, Inc. (OAPI), which is focused on commercializing Otsuka-discovered and in-licensed products in North America, and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), which specializes in the clinical development and global registration of innovative healthcare solutions, particularly in the field of neuroscience.

📋 Description

• 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

• 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

• 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

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