Director, Drug Product Development – Sterile Products

This is a fully remote position, open to applicants in United States.

📋 Description

• Spearhead strategic and technical development of sterile drug products throughout both clinical and commercial lifecycles.

• Implement sterile drug product strategies for small-molecule and ASO programs, ensuring alignment with CMC, clinical, and commercial goals.

• Act as the subject matter expert in sterile drug products for cross-functional program teams and governance forums.

• Provide technical direction on formulation design, aseptic processing methodologies, and control strategies.

• Oversee the development of sterile injectable liquids, suspensions, and lyophilized dosage forms.

• Supervise formulation robustness, ASO stability, excipient compatibility, and container-closure interactions.

• Drive the development and optimization of aseptic manufacturing processes, including filtration, filling, and lyophilization cycles.

• Lead the selection and qualification of vials, stoppers, prefilled syringes, and cartridges.

• Manage container-closure integrity strategies, compatibility assessments, and evaluations of extractables/leachables.

• Direct clinical-to-commercial scale-up, aseptic process simulations, and robustness studies.

• Oversee process performance qualification, ongoing process verification, and post-approval lifecycle management.

• Ensure preparedness for global commercial launch and consistent supply.

• Select, onboard, and oversee sterile formulation and fill-finish CDMOs.

• Lead technology transfers, site transitions, and secondary sourcing efforts.

• Establish technical governance frameworks and development plans in collaboration with external partners.

• Provide CMC insights for IND, NDA, and global regulatory submissions.

• Assist in health authority interactions, responding to information requests, and preparing for inspections and audits.

• Ensure adherence to GMPs, ICH guidelines, and global regulatory standards.

• Collaborate with Analytical Development/QC on methods, specifications, stability programs, and impurity control strategies.

• Work alongside Quality to ensure aseptic compliance, manage deviations, and prepare for inspections.

• Partner with MSAT and Supply Chain to guarantee a reliable clinical and commercial sterile supply.

• Lead and mentor a high-performing team focused on sterile drug product development.

• Manage development budgets, timelines, and resources across various programs.

• Foster scientific rigor, compliance, accountability, and continuous improvement initiatives.

⛳️ Requirements

• PhD in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a related field OR an MS with substantial relevant industry experience.

• Over 10 years of experience in pharmaceutical development.

• At least 5 years in a leadership position.

• Proven track record in leading sterile drug product development, including antisense oligonucleotide (ASO) products, from early phases to commercialization.

• Extensive experience working with aseptic manufacturing and fill-finish CDMOs, particularly in oligonucleotide-capable facilities.

• Demonstrated support for IND/NDA submissions and regulatory inspections pertaining to sterile products.

• In-depth knowledge of sterile formulation and aseptic process development.

• Experience in ASO drug product development, covering formulation stability, degradation pathways, and parenteral delivery methods.

• Strong comprehension of lyophilization, filtration, filling, container-closure integrity, and aseptic controls.

• Solid understanding of GMPs, ICH guidance, and regulatory expectations concerning sterile and oligonucleotide products.

• Familiarity with global submissions for the US, EU, Japan, and emerging markets.

• Experience managing post-approval changes, comparability, and site transfers for sterile injectables.

• Knowledge of commercial aseptic operations and optimization of cost-of-goods.

• Ability to exhibit accountability, strategic thinking, problem-solving skills, patient and customer focus, effective communication, respectful collaboration, and empowerment in development.

🏝️ Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage.

• Basic life insurance provided by the company.

• Accidental death and dismemberment insurance.

• Short-term and long-term disability insurance.

• Tuition reimbursement program.

• Assistance with student loans.

• Generous 401(k) matching contributions.

• Flexible time off policy.

• Paid holidays.

• Paid leave programs.

• Additional company-sponsored benefits.

• Opportunity for incentives.