Associate Director - Drug Product Manufacturing & Development

Role Summary

Associate Director of Drug Product Manufacturing & Development responsible for all clinical drug product manufacturing including process characterization to support commercialization for nucleic acid programs, with thorough knowledge of cGMPs for aseptic pharmaceutical products. Leads a team of Drug Product Managers, manages CMOs to ensure continuous product supply, conducts formulation studies, and collaborates across multiple departments.

Responsibilities

• Lead, manage, and advise all aspects of drug product manufacturing operations at CMOs to manufacture clinical parenteral medicines according to approved protocols, master batch records, regulations, and timelines
• Lead and be an example for a drug product team responsible for ensuring clinical supply using aseptic manufacturing
• Identify and work with formulation development CROs to implement new production processes at CMOs and NDA-enabling work, including formulation, sterilization, filling, and lyophilization
• Responsible for key manufacturing metrics/goals, support critical program milestones, and drive continuous improvement initiatives
• Rapidly and accurately communicate issues to Senior Leadership; resolve manufacturing and facility issues to mitigate supply disruptions
• Work across Quality Assurance/Control, Chemical Development, Program Management, Regulatory, Analytical Development, Materials Management, and Clinical Supply
• Write, review, and/or approve SOPs, specifications, regulatory filings, Master/Executed Batch Records, or other controlled documents
• Manage timelines, production plans, and material requirements
• Manage DP team resource loading and personnel development
• Ensure effective use of material, equipment, and personnel in producing quality products
• Optimize and investigate formulation, sterilization, and filling processes and parameters through experiments in a laboratory setting

Qualifications

• Bachelor‚Äôs degree with 9+ years of experience, Master‚Äôs degree with 7+ years of experience, or PhD with 5+ years of experience in a cGMP setting; degree in Biochemistry/Chemistry/Engineering or related discipline
• In-depth experience in pharmaceutical operations associated with aseptic processing
• Proven leadership of technical teams
• Experience with regulatory compliance of Aseptic Processing facilities
• Understanding of engineering and process knowledge for sterilization technologies, GMP utilities, and related pharmaceutical processes
• Experience with drug product formulation development and optimization (preferred)
• Understanding of equipment, instrumentation, and materials of construction to design, procure, start-up, commission, and troubleshoot equipment and systems
• Ability to perform risk assessments
• Experience in problem solving and continuous improvement techniques
• Excellent verbal and written communication skills
• Ability to manage CMOs effectively
• Strong planning and organizational skills; ability to meet targets and deadlines
• Proficient in MS Word, Excel, MS Project, and PowerPoint
• Understanding of national and international regulatory requirements related to Aseptic Manufacturing
• Proficient in generating and executing protocols and reports

Skills

• Leadership of technical teams
• Aseptic processing and GMP compliance
• Process development and optimization
• Regulatory documentation and filings
• Project and resource management
• Cross-functional collaboration
• Risk assessment and continuous improvement

Education

• Bachelor‚Äôs, Master‚Äôs, or PhD in Biochemistry, Chemistry, Engineering, or related discipline

Additional Requirements

• Approximately 15 ‚Äì 20% overnight travel
• Physical ability to lift 0 ‚Äì 10 lbs