Director of Process Validation

Director of Process Validation

Requirements

• Bachelor’s or Master’s Degree or Ph.D. in Organic Chemistry, Chemical Engineering, or a related field
• 5+ years’ experience formally leading people, projects and/or programs; 10+ years preferred
• 10+ years’ experience in chemical process development, particularly in the pharmaceutical industry
• Experience with GMP manufacturing process validation in accordance with FDA regulations
• Strong understanding of chemical process validation and control strategies for process optimization
• Proficiency in process validation stages (Stage 1, 2, and 3) and familiarity with regulatory guidelines (FDA, EU EudraLex)
• Experience developing robust, scalable processes for API production used in clinical and commercial settings
• Effective communication skills for engaging with clients and regulatory bodies
• Experience preparing technical reports and chemical process descriptions for internal technology transfer and client submissions
• Experience in responding to client RFPs and representing process validation in audit settings

Responsibilities

• Lead and manage a team of scientists and managers that develop chemical processes for manufacture of oligonucleotide APIs.
• Lead and manage process validation programs in accordance with FDAs Stage 1, 2 and 3 and EU EudraLex.
• Ensures programs are compliant and justifiable with Company policies and regulatory guidance’s.
• Apply organic chemistry development experience with control strategies to issues of process optimization, scale-up and laboratory process transfer to mid and kilo-scale GMP manufacturing.
• Oversee development of robust, scalable processes for API production that is used in clinical and commercial settings.
• Responsible for optimization and scale-up of processes and process validation activities, ensuring the successful transition of early stage to late stage/commercially viable processes.
• Responsible for preparing chemical process descriptions and writing technical reports to support internal technology transfer into manufacturing and support in preparation of client CMC submissions.
• Provide regular interface with clients that includes project proposal generation, technical goals, activities and status updates and summary documents of the project.
• Direct the day-to-day activities of direct reports and project teams, maintaining progress on projects and ensuring that experiments are complete and scientifically sound.
• Oversee regular internal project review meetings and ensures schedules meet the timeline requirements.
• Contribute to responses to client RFP (request for proposal) including technical approach and resource allocation.
• Responsible for representing process validation to customer and regulatory bodies in both written responses and audit settings.

Preferred Qualifications

No preferred qualifications provided.