The Vice- President, Instrumentation Platform directs the design, development, manufacturing, operations, customer support, quality and regulatory requirements associated with all aspects of MaxCyte's™ cell loading platform. S/He executes on the company's operating plan to supports business objectives and support of customers in drug discovery markets, licensing partners in therapeutic development markets, and MaxCyte's™ proprietary cell-based therapeutic product needs. This individual defines strategy and manages activities related to continual refinement in performance of the Platform, upscaling of manufacturing, consolidation of supply chain, development of novel Product offerings, strengthening of intellectual property, and preparing platform for therapeutic commercial launch.
Maintains quality of current Platform products, including instrumentation systems, software, single-use processing assemblies buffers and allied products
Enhances quality of products, including compliance with global quality and regulatory requirements, where required, improvements in performance characteristics, and scalability of manufacturing processes to meet larger volume of market demand
Ensures adequate supply of Platform products, including Instrumentation systems, software, single-use processing assemblies and buffers
Manages product life cycle for existing products, and develops strategy and oversees implementation of expansion of Platform capabilities, performance, smartness, ease of use, and expansion of intellectual property
Evolves product line to support business strategy and entry into new markets or applications
Defines requirements and implements systems for use of Platform as manufacturing enabling technology for clinical delivery of therapeutics; including processing, quality and regulatory requirements such as 21CFR Part 11, HIPPA, Chain of Identity, Chain of Custody, 510(k), CE mark, regulatory Master File or equivalent
Develops strategy and partnership for integration into commercial environment for delivery of novel cell-based therapies; including considerations for regulatory requirements, reimbursement and commercial manufacturing/delivery
Complies with all applicable policies regarding health, safety, and environmental policies
MS/PhD and/or MBA with experiences in developing and manufacturing enabling technologies, medical devices, transfusion systems or related area with at least 10 years of experience in a senior management role with responsibilities for Research and Development, manufacturing, operations and strategy for similar products; or equivalent
Solid understanding medical devices or therapeutics delivery platforms; and their design, development, manufacturing, operations, quality and regulatory requirements
Proven track record of leading design and manufacturing under appropriate quality systems and managing external contractors and supply chain to ensure adequate supply of products to meet business needs. Excellent analytical skills
Strong networking, organizational, and communication skills along with solid interpersonal behavior to work collaboratively with diverse functional teams in an entrepreneurial environment
Ability to quickly set priorities and develop practical plans. Attention to detail and ability to work simultaneously on multiple priorities with tight timeline with strong project management, communication, analytical and presentation skills
Excellent written and oral communication skills to interact with all levels of internal and external customers. Ability to work effectively across all levels of management.
Strong work ethic; self-motivation; dedication; a results orientation; and entrepreneurial. Ability to excel in a small-company environment. Demonstrated business acumen
Evidence of sound judgment, high energy and be a proactive thinker that can produce results in a timely fashion. A hands-on approach to business development as well as a "get-the-job-done" mentality is required.
MaxCyte is the leader in cell transfection with a world-wide marketed flow electroporation platform spanning the discovery, development, clinical, and manufacturing applications of virtually all classes of innovative therapeutics. MaxCyte's customers and partners utilize its technologies in the development and commercialization of cell-based therapies in regenerative medicine and active cell immun...otherapies and in the discovery and development of protein drugs, monoclonal antibodies, vaccines, and small molecule drugs. MaxCyte is located in Gaithersburg, Maryland.