Annex A - Job Description
Chief Operations Officer (COO)
Reporting to the CEO and based either in Amsterdam, Netherlands or in Lexington, MA, the Chief Operations Officer (COO) will be responsible for all cGMP relevant activities within uniQure including oversight of cGMP manufacturing, supply chain, facilities and all technical operations, including process and analytical development. While cGMP manufacturing is consolidated in the company’s Lexington, MA facility, this is an end-to-end global role that includes early product development functions located in Amsterdam, Netherlands. Areas of specific responsibility and accountability include:
◾Designing the Company’s CMC strategy and tactical execution, including oversite of cGMP manufacturing, supply chain, facilities, and all technical operations, including process and analytical development.
◾Supplying drug substance and drug product for large animal studies, clinical trials, and commercial applications in compliance with all relevant regulatory requirements.
◾Ensuring appropriate CMC capacity and delivering high quality and cost-effective development and manufacturing of the Company’s products and product candidates.
◾Investing in and maintaining the Company’s premises, utilities, and equipment.
◾Developing and directing strategies for upstream and downstream process development, analytical development, formulation development and manufacturing in alignment with Clinical, Quality, Regulatory and Commercial requirements.
◾Collaborating with Quality and other functional areas to efficiently manage technology transfer, process scale-up and design of validation strategies with regards to routine/non-routine development and cGMP activities (e.g., deviations/investigations, process improvements, change controls, shelf-life extensions, CAPAs, etc.).
◾Developing batch records, experimental data, protocols, reports, analytical methods, SOPs, etc.
◾Authoring and reviewing technical sections for company’s global regulatory submissions (INDs, IMPDs, BLAs, MAAs, Meeting Requests, Briefing Documents, responses to Health Authority questions, etc.) related to assigned programs.
◾Conducting any process verification and qualification studies.
◾Contributing to the generation and protection of company intellectual property.
◾Overseeing the development and maintenance of the budget for assigned program activities, including the preparation of cost estimates for new work.
◾Defining, implementing, maintaining, and improving processes and systems, supported by meaningful Key Performance Indicators (KPI’s).
◾Building best-in-class operations teams and leaders, including recruitment, performance management, mentorship, career development and succession planning.
◾Collaborating seamlessly with other functional disciplines to ensure day-to-day cooperation and advance the Company’s business objectives.