Vice President, Instrumentation Platform (20170801-VPIP-001) - Gaithersburg, MD | Biospace
Get Our FREE Industry eNewsletter

Vice President, Instrumentation Platform (20170801-VPIP-001)

MaxCyte, Inc.

Location:
Gaithersburg, MD
Posted Date:
8/2/2017
Position Type:
Part time
Job Code:
20170801-VPIP-001
Salary:
Required Education:
Masters Degree
Areas of Expertise Desired:
Cell, MBA, PhD, Vice President, VP,

Job Description


About MaxCyte:

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 immunotherapies and in the discovery and development of protein drugs, monoclonal antibodies, vaccines, and small molecule drugs. MaxCyte is located in Gaithersburg, Maryland.

Job Summary:

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.  

Job Duties:

•   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

Requirements


Job Requirements:

•   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, Inc. is an equal opportunity employer. To apply, please submit your resume and cover letter, referencing job number 20170801-VPIP-001.