Associate Director of Product Development

Position Summary

The Associate Director, Product Development is responsible for leading the formulation, process development, scale-up, and technology transfer of sterile injectable pharmaceutical products. This role oversees product development activities from feasibility assessment through commercialization, ensuring scientifically sound development strategies, regulatory compliance, and successful transfer to manufacturing.

The Associate Director will provide technical leadership for formulation and process development initiatives involving vials and prefilled syringes, utilizing Quality by Design (QbD) principles and risk-based methodologies. The role partners closely with Manufacturing, Quality Assurance, Quality Control, Engineering, Regulatory Affairs, and external partners to accelerate product development timelines while maintaining the highest standards of quality and compliance. This position also leads project teams, manages development resources, and supports organizational growth through scientific innovation and operational excellence.

• Prepare feasibility assessments, development plans, timelines, and cost estimates for leadership review.
• Evaluate product opportunities and development strategies to support portfolio expansion and commercialization objectives.
• Identify development risks and recommend mitigation strategies to ensure successful project execution.

• Lead formulation development of sterile injectable solutions in vials and prefilled syringes.
• Design and execute pre-formulation studies, including solubility assessments, pH stability profiling, and excipient compatibility evaluations.
• Conduct forced degradation studies to characterize degradation pathways and support formulation and packaging decisions.
• Apply Quality by Design (QbD) principles and risk-based methodologies in accordance with ICH Q8(R2) and Q9 guidelines.
• Identify critical quality attributes (CQAs), critical process parameters (CPPs), and design robust development strategies using Design of Experiments (DoE).

• Develop compounding, mixing, filtration, and filling processes suitable for commercial-scale manufacturing.
• Establish sterilization strategies, including terminal sterilization and aseptic processing approaches.
• Support filter selection, compatibility studies, and bacterial retention evaluations.
• Conduct hold-time studies for bulk solutions and in-process materials.
• Assess manufacturability risks and establish process controls and in-process testing requirements.

• Select and qualify primary packaging components for sterile injectable products.
• Evaluate container closure systems, extractables and leachables, and product-container compatibility.
• Design and oversee accelerated, in-use, and long-term stability studies to support shelf-life and beyond-use dating determinations.
• Collaborate with Analytical Development and Quality Control teams to establish stability-indicating methods, product specifications, and stability trending programs.

• Lead engineering, feasibility, pilot, and validation batches.
• Author development reports, formulation records, manufacturing batch records, and supporting documentation.
• Manage technology transfer activities from development through commercial manufacturing.
• Collaborate with Production, Engineering, Quality Assurance, and Quality Control to ensure successful scale-up and process implementation.
• Support process validation activities and provide technical expertise to address manufacturing challenges.
• Participate in change control, deviation investigations, and continuous improvement initiatives.

• Ensure all development activities comply with FDA CGMP requirements and internal quality systems.
• Provide technical support and content for product labeling, regulatory submissions, and FDA reporting requirements.
• Maintain complete, accurate, and audit-ready development documentation.
• Support regulatory inspections, customer audits, and quality system assessments.

• Manage project timelines, budgets, milestones, and resource allocation to support development objectives.
• Coordinate activities with contract research organizations (CROs), testing laboratories, suppliers, and manufacturing partners.
• Communicate project progress, risks, challenges, and recommendations to senior leadership and key…