PURPOSE: The position manages all aspects of manufacturing for the company, focusing on CMOs producing drug substance (plasmid) and drug product. The Director will drive process engineering and execution to support current and future manufacturing needs for clinical trials and commercialization. The position requires direct oversight of international contractors, effective collaboration with R&D in Israel, with Quality personnel, and coordination with Clinical Development in the US to improve upon and scale existing processes to support current clinical needs while evolving towards commercial stage manufacturing.
• Management of existing CMO producing and maintaining the product and its intermediates
• Oversees critical business relationships and actively manages documentation, supply, inventory, logistics, and production plans / forecasting;
• Integrates external partners and vendors supplying CMOs with materials and services
• Drives the resolution of issues as they arise due to process variability and deviations;
• Coordinates, writes, and tracks study protocols and study reports pertaining to process development, qualifications and validations;
• Lead process characterization and validation campaign at established and larger scales capable of continuously providing final product for late-stage clinical trials and commercialization
• Oversees product stability, including design of stability studies, shelf life determination of intermediates and final product and coverage of domestic and international shipments.
• Responsible for generation and completion of CMC-related content and documentation for regulatory submissions (FDA and other regions)
• Ensure compliance with GMP / ICH Quality System requirements, both internally and at CMOs (e.g., SOPs, batch records, bill of materials, etc.) through extensive collaboration with Quality personnel
• Forges synergistic relationships across the organization: with the existing manufacturing consultant; with R&D, the primary partner in development and translation of processes, with quality personnel & with Clinical Development for a robust clinical supply chain.
• Coordinates with R&D in the development of CPPs and CQAs using reliable analytical techniques, from which in-process and release (e.g., potency) assays emerge and to establish grounds for process validation.
• Leads as the company’s main point of manufacturing expertise, contributing as a technical subject matter expert
• Defines manufacturing’s vision through the strategic plan, and execute against objectives.
• Serves as head of the Manufacturing department, including setting of his/her team’s objectives, deliverables, budget, administrative duties (e.g., reviews).
• Identifies and implements industry standards, technical and business process metrics to ensure operations are performing effectively, efficiently and on-par with industry and clinical phase-appropriate expectations.
• Represents the company in a professional manner at speaking engagements, conferences, partner meetings, and regulatory meetings.
KNOWLEDGE AND SKILL REQUIREMENTS:
• Knowledge of cGMP / ICH compliance regulations for manufacturing of biological products, primarily for the US / FDA market
• Experience with microbial culture and purification (experience with plasmid DNA manufacturing is an advantage), assays, release criteria, etc., including understanding of evolving standards and industry best practices.
• Intimate understanding of and experience with the discipline of process engineering
• Ability to work in a fast-paced, global, small company environment
• Highly organized, detail oriented, results driven and accountable for his/her discipline
• Effective verbal and written communication skills, including high emotional intelligence
• Ability to work in a collaborative group setting, and able to work with and through others
• Willingness to travel internationally as required
EDUCATION AND EXPERIENCE:
• BS/MS or PhD in degree in pertinent biologic or engineering discipline
• 8+ years’ of relevant industry experience including:
• Managing FDA-regulated biological GMP manufacturing.
• Management experience; direct supervision and managing remote teams
• Creation or significant contribution to CMC sections of an IND or BLA