Jennifer Bicknell Email & Phone Number

Hopewell, New Jersey, United States

- Establish site GMP training program, documentation and change control system in compliance with company's global standards.- Lead and manage site GMP training program, documentation and change control system, monitoring the implementation to ensure compliance within house procedures and FDA/EU regulation.- Support regulatory inspections, internal and.

Syracuse, New York

- Tested and participated in the rollout of the Veeva Commercial Change Management system- Veeva Change Champion for the analytical organization- Led the Analytical Change Control team for commercial biologics and small molecule products

Syracuse, New York Area

- Created and launched new TrackWise biologics analytical change control process. Defined process/workflow ensuring alignment with directives and governance structure, developed SOP (Standard Operating Procedure) and guidance documents to support new process.- Established global cross-functional Analytical Network Review (ANR) meeting to provide a forum.

Syracuse, New York Area

- Established business process for Chemistry Manufacturing and Controls (CMC) support. Assisted with creation of SOP to govern regulatory process. Core team member on CMC authoring initiative. CARA3 subject matter expert (SME) for the Syracuse site- Created/reviewed CMC sections of biologics products for global regulatory submissions and implemented into.

Syracuse, New York Area

- Analyzed and compiled the essential data being used to populate documents written for FDA authorization - Executed the leadership and guidance necessary to build and maintain a unified and structured team - Provided direction and assistance to others to clarify their expectations and role within the team- Established personal and team goals and.