Director, Drug Product Development – Sterile Products

🔥 17 minutes ago

🇺🇸 United States – Remote

💵 $186.5k - $278.9k / year

⏰ Full Time

🔴 Lead

👔 Director

👻 Ghost score 0%

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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 strategic and technical sterile drug product development across clinical and commercial lifecycles • Execute sterile drug product strategies for small-molecule and ASO programs aligned with CMC, clinical, and commercial objectives • Serve as sterile drug product subject matter expert on cross-functional program teams and governance forums • Provide technical leadership on formulation design, aseptic processing approaches, and control strategies • Lead development of sterile injectable liquids, suspensions, and lyophilized dosage forms • Oversee formulation robustness, ASO stability, excipient compatibility, and container-closure interactions • Drive aseptic manufacturing process development and optimization, including filtration, filling, and lyophilization cycles • Lead selection and qualification of vials, stoppers, prefilled syringes, and cartridges • Oversee container-closure integrity strategies, compatibility, and extractables/leachables assessments • Lead clinical-to-commercial scale-up, aseptic process simulations, and robustness studies • Oversee process performance qualification, continued process verification, and post-approval lifecycle management • Ensure readiness for global commercial launch and sustained supply • Select, onboard, and manage sterile formulation and fill-finish CDMOs • Lead technology transfers, site changes, and secondary sourcing • Establish technical governance models and development plans with external partners • Provide CMC input for IND, NDA, and global regulatory submissions • Support health authority interactions, requests for information, inspections, and audits • Ensure compliance with GMPs, ICH guidelines, and global regulatory expectations • Partner with Analytical Development/QC on methods, specifications, stability programs, and impurity control strategies • Collaborate with Quality on aseptic compliance, deviation management, and inspection readiness • Work with MSAT and Supply Chain to ensure reliable clinical and commercial sterile supply • Lead and mentor a high-performing sterile drug product development team • Manage development budgets, timelines, and resources across multiple programs • Promote scientific rigor, compliance, accountability, and continuous improvement

🎯 Requirements

• PhD in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, Chemistry, or related discipline OR MS with significant relevant industry experience • 10+ years of pharmaceutical development experience • 5+ years in a leadership role • Demonstrated experience leading sterile drug product development, including antisense oligonucleotide (ASO) products, from early phase through commercialization • Strong experience working with aseptic manufacturing and fill-finish CDMOs, including oligonucleotide-capable facilities • Proven support of IND/NDA filings and regulatory inspections for sterile products • Deep expertise in sterile formulation and aseptic process development • Experience with ASO drug product development, including formulation stability, degradation pathways, and parenteral delivery • Strong understanding of lyophilization, filtration, filling, container-closure integrity, and aseptic controls • Solid knowledge of GMPs, ICH guidance, and regulatory expectations for sterile and oligonucleotide products • Experience supporting global submissions for the US, EU, Japan, and emerging markets • Experience with post-approval changes, comparability, and site transfers for sterile injectables • Experience with commercial aseptic operations and cost-of-goods optimization • Ability to demonstrate accountability, strategic thinking, problem solving, patient and customer centricity, impactful communication, respectful collaboration, and empowered development

🏖️ 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