Position SummaryThe 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.
Key ResponsibilitiesPortfolio Management- 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.
Formulation Development- 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).
Process Development & Sterilization Strategy- 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.
Packaging & Stability- 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.
Scale-Up & Technology Transfer- 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.
Regulatory Compliance & Documentation- 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.
Project Leadership & Cross-Functional Collaboration- 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 stakeholders.
- Drive alignment and collaboration across technical, quality, manufacturing, and commercial teams.
People Leadership & Team Development- Recruit, mentor, coach, and develop formulation and process development scientists.
- Establish clear goals, priorities, and performance expectations for development teams.
- Foster a culture of innovation, accountability, collaboration, and continuous improvement.
- Support succession planning and technical capability development within the Product Development function.
QualificationsRequired:- Bachelor's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biomedical Engineering, or a related scientific discipline.
- 8+ years of progressive experience in pharmaceutical product development, formulation development, or process development.
- Demonstrated experience developing sterile injectable products for commercial manufacturing.
- Strong knowledge of aseptic processing, sterilization technologies, formulation science, and process development.
- Experience applying QbD principles, risk assessments, and Design of Experiments (DoE).
- Working knowledge of FDA regulations, CGMP requirements, and ICH guidelines.
- Experience with technology transfer, validation activities, and commercial manufacturing support.
- Strong project management, problem-solving, and technical leadership capabilities.
- Excellent communication and cross-functional collaboration skills.
Preferred:- Master's degree or PhD in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field.
- Experience with FDA regulatory submissions and product lifecycle management.
- Experience leading teams within a sterile pharmaceutical manufacturing environment.
- Knowledge of extractables/leachables studies, container closure systems, and advanced formulation technologies.
Key Competencies- Sterile Injectable Product Development
- Pharmaceutical Formulation Science
- Process Development & Scale-Up
- Technology Transfer
- Quality by Design (QbD)
- Risk Management & Design of Experiments (DoE)
- Sterilization & Aseptic Processing
- Stability Program Management
- Regulatory Compliance & CGMP
- Project & Portfolio Management
- Cross-Functional Leadership
- Scientific Problem Solving
- Team Development & Mentoring
- Technical Documentation
- Strategic Planning & Execution
- Continuous Improvement
What Success Looks Like- Successfully develop and commercialize sterile injectable products that meet quality, regulatory, and business requirements.
- Execute development programs on schedule and within budget.
- Establish robust formulations and manufacturing processes that support scalable commercial production.
- Deliver successful technology transfers and validation programs.
- Maintain inspection-ready documentation and regulatory compliance throughout development activities.
- Build a high-performing product development team with strong technical capabilities.
- Foster collaboration across Product Development, Manufacturing, Quality, Engineering, and Regulatory Affairs.
- Drive innovation, operational excellence, and continuous improvement within the Product Development organization.
