Marshall Parker Email & Phone Number

Leland, North Carolina, United States

"Cygnus Technologies, part of Maravai LifeSciences, is the biopharmaceutical industry’s partner in host cell protein (HCP) and other process-related impurity detection and analytics as well as in innovative viral clearance solutions. Cygnus helps companies developing therapeutic proteins, vaccines, antibodies, plasma derivatives and gene therapies to ensure the safety of biotherapeutics prior to human trials, regulatory approval and commercial release."

Warwick, Ri

Becton Dickinson (BD) Interventional Surgery BU, Warwick RIAssociate Director Quality, Biologics Platform Lead (2021 -10/2023);Quality Engineering Manager-Biologics (2011); Quality Engineer (2009)Demonstrated career progression with increasing responsibilities from quality engineer to current role leading Biologics platform driving Class III product development, commercialization and sustaining activities.Excellent organizational awareness cross-functionally and in global, cross-cultural teams.Successful product launches including synthetic and biologic 510k and Class III medical devices, including highly successful drug coated biological mesh, hemostats and surgical sealants. Member of BD Biosurgery global BU Quality Leadership Team and Product Steering Committees, providing enterprise strategic direction, driving global QMS harmonization, due diligence support and acquisition integration.Biologics Platform Core Team quality lead providing business partner strategy, regulatory response, quality engineering resource allocation and cross-functional team oversight for medical device/drug indications including surgical sealants, hemostats and combination products.Leadership and technical expertise engaging teams in design control, risk management, method development, V&V, stability programs, manufacturing transfer, scale-up, site readiness, critical supplier/CMO/ CTL management and Quality Control laboratory operations.Oversight and expertise engaging teams in non-conformance and OOS events, CAPA, failure investigations and resolution. Skilled in identifying and managing talent, building cross-functional NPD and sustaining teams and associate growth and development.

Delivered technical expertise and organizational leadership while creating, implementing and managing ISO13485 and CFR Part 820 compliant QMS, quality control and analytical chemistry operations in support of the development and commercialization of a pulmonary drug/device delivery system (Combination Product).