VP Technical Operations and Process Sciences
Reporting to the CEO, and joining the Executive Committee, the VP of Technical Operations and Process Sciences will be responsible for ensuring the development and ongoing evolution of the company’s core technical operations competencies into a world class organization. In the near term this person would be responsible for managing timelines and executing on securing CMO slots and ensuring tech transfer of GLP and early clinical material in a timely manner. This person would also support all CMC-related activity related to fling and supporting an IND. As the organization evolves from clinical to commercial operations, the VP/SVP, Technical Operations will contribute to the organization’s commercial success by continuously driving manufacturing costs down while concurrently reducing turn-around time of its manufacturing processes. Hands-on responsibility for managing manufacturing, process engineering and analytical support functions to assure successful knowledge transfer, plant start-up, monitoring and continuous process improvements.
Position Duties and Responsibilities
• Lead all elements of technical product development, manufacturing and supply chain resources to achieve global registration, production and eventual commercial launch of products in target indications.
• As a member of the Executive Committee contributes to Amunix’s strategic business plan, product initiatives and portfolio management decisions to achieve overall business success.
• Direct relationships with all external technical (CMOs), commercial and professional organizations needed to achieve critical goals and objectives.
• Manage technical scale-up and transfer activities for a timely and successful transition to commercial manufacturing environment.
• Create rigorous technical review and critique program(s) for all external vendors. Personally participate in selected reviews and provide feedback, including recommendations to vendors for implementation of all necessary improvements.
• Ensure that production is achieved in an efficient, effective manner. Provide resources and leadership to ensure supply chain activities are conducted in a regulatory compliant manner.
• Ensure appropriate and necessary CMC information, including manufacturing, packaging, quality technical and stability studies are properly conducted and documented for regulatory filings. Deliberately build and maintain strong and productive relationship with all relevant regulators.
• Develop analytical capabilities and lead an agile team to establish development and manufacturing processes to build a portfolio of protein engineered therapeutics
• Collaborate with clinical, translational, PK, regulatory to innovate on a novel platform and to integrate a development strategy to bring forward a portfolio of next generation, non-immunogenic therapeutic molecules to the clinic
• Oversee formulations and stability
• Drive development of product plans, risk management, CMC, regulatory strategies for new product submissions
• Lead communications around tech ops, timelines etc. have the ability to know the details but be able to prioritize and synthesize communications at an executive level
• 15+ years of increasingly senior leadership experience in a mid-sized or larger biopharmaceutical company holding end-to-end responsibilities for the development, commercialization and introduction of protein therapeutic
• Experience leading an Operations team for a cutting-edge innovative product through all stages of development, clinical trials and commercial launch
• Experience leading and executing an organization’s network strategy including Phase I/II plant design, construction and certification, contract manufacturing relationships management (both outsourcing and/or in-sourcing), as well as management of all supply chain resources.
• Solid knowledge, technical skills and proven experience in biological drug substance and drug product development
• Proven experience with preparation of CMC information for regulatory submission
• In-depth understanding of ICH guidelines and regulatory requirements for cGMP manufacture of Biologics
• Experience with microbial production of biologics is desired but not necessary
• A PhD or Master’s degree in a relevant scientific or technical field.