Director, Drug Product Development, Sterile Products

The Director, Drug Product Development – Sterile Products is responsible for the strategic and technical leadership of sterile drug product development across the clinical and commercial lifecycle, with emphasis on small molecule sterile injectables and antisense oligonucleotide (ASO) drug products. This role oversees formulation development, aseptic process development, scale up, validation, and lifecycle management for parenteral products, primarily executed through external CDMOs.
The Director ensures robust, phase appropriate sterile drug product strategies that meet global regulatory expectations and enable reliable clinical and commercial supply. This role partners closely with Quality, Regulatory Affairs, Analytical Development, MSAT, and Supply Chain to maintain inspection readiness and operational excellence.
Key Responsibilities
Sterile Drug Product Strategy & Leadership
Lead and aseptic execute sterile drug product development strategies for small‑molecule and ASO programs, aligned with CMC, clinical, and commercial objectives.
Serve as the sterile drug product subject matter expert, including ASO parenteral products, on cross‑functional program teams and governance forums.
Provide technical leadership on formulation design, aseptic processing approaches, and control strategies tailored to oligonucleotide‑based products.
Formulation & Aseptic Process Development
Lead development of sterile injectable products, including liquid solutions, suspensions, and lyophilized dosage forms, for both small molecules and ASOs.
Oversee formulation robustness, ASO stability considerations (e.g., degradation pathways, pH, ionic strength), excipient compatibility, and container–closure interactions.
Drive development and optimization of aseptic manufacturing processes, including filtration, filling, and lyophilization cycles appropriate for oligonucleotide drug products.
Container–Closure Systems & Product Presentation
Lead selection and qualification of vials, stoppers, prefilled syringes, and cartridges for sterile and ASO products.
Oversee container–closure integrity (CCI) strategies, compatibility, and extractables/leachables assessments.
Ensure robust sterile and ASO product presentation strategies suitable for clinical and commercial use.
Scale‑Up, Validation & Commercial Readiness
Lead clinical‑to‑commercial scale‑up for sterile and ASO products, including aseptic process simulations (media fills) and robustness studies.
Oversee process performance qualification (PPQ), continued process verification (CPV), and post‑approval lifecycle management.
Ensure sterile and ASO drug product readiness for global commercial launch and sustained supply.
CDMO Oversight & Technology Transfer
Select, onboard, and manage sterile formulation and fill‑finish CDMOs, including those with oligonucleotide handling capabilities.
Lead technology transfer activities for ASO and small‑molecule sterile products, including site changes and secondary sourcing.
Establish strong technical governance models and development plans with external partners.
Regulatory & Compliance Support
Provide sterile and ASO drug product CMC input for IND, NDA, and global regulatory submissions (e.g., Module 3.2.P).
Support health authority interactions, RFIs, inspections, and audits, with emphasis on aseptic processing and oligonucleotide‑specific controls.
Ensure compliance with GMPs, ICH guidelines, and global regulatory expectations for sterile and ASO products.
Cross‑Functional Collaboration
Partner with Analytical Development/QC to ensure appropriate methods, specifications, stability programs, and impurity control strategies for ASOs.
Collaborate with Quality to ensure aseptic compliance, deviation management, and inspection readiness.
Work closely with MSAT and Supply Chain to ensure reliable clinical and commercial sterile supply.
People, Budget & Program Management
Lead and mentora high‑performing sterile drug product development team
Manage development budgets, timelines, and resources across multiple sterile and ASO programs.
Promote a culture of scientific rigor, compliance, accountability, and continuous improvement.
Required Qualifications
Education
PhD in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, Chemistry, or related discipline OR
MS with significant relevant industry experience
Experience
10+ years of pharmaceutical development experience, with 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.
Technical Expertise
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, CCI, and aseptic controls.
Solid knowledge of GMPs, ICH guidance, and regulatory expectations for sterile and oligonucleotide products.
Experience supporting global submissions (US, EU, Japan, emerging markets) for ASO products.
Experience with post‑approval changes, comparability, and site transfers for sterile injectables.
Experience with commercial aseptic operations and cost‑of‑goods optimization.
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.
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: This will be posted for a minimum of 5 business days.
Company benefits: 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. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
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.
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