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 external audits. - Establish departmental SOPs (writing, revising and approving) ensuring regulatory compliance in conjunction with being ‘fit for purpose’ operationally and commercially.- Manage, motivate, coach and mentor direct reports, to higher levels of management capability.

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 for change control discussion within the world-wide network. Facilitate ANR meeting twice weekly, encourage discussion, request feedback, review change control record, and capture meeting minutes.- Perform detailed review of change controls for accuracy, robustness, and completeness within extremely tight timelines.- Continually monitor and drive multiple change controls to approval and closure by tracking action items, impact assessments, quality approvals, and executables (child actions) ensuring timelines are met to support regulatory submissions and/or manufacturing.- Created and maintain tracking sheet for TrackWise child actions to aid in driving change controls to closure. Present and discuss tracking sheet monthly at subteam meetings for commercial products.- Identify causes of rework and delay, and implement actions to streamline process.- Global team member to pressure test initial prototype of new lean change control system. Participated in global discussions involving the prototype and provided feedback to vendor.- Provide Trackwise training to new employees - Created and launched department SharePoint site

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 CARA regulatory system.- Document coordinator lead for dual BLA (Biologics License Application), facilitated meetings, tracked and managed timelines. - Front room document coordinator for health authority inspections ensuring that auditor requests are accurately captured and successfully retrieved in a timely manner- Conducted audits of the document control room - Continually evaluated SOPs to ensure efficiency and accuracy - Assisted various cross-functional groups with review, verification and formatting of protocols and reports within established timelines. Facilitated document review meetings, performed live editing and tracked through completion.- Collaborated with IM (Information Management) to establish a new web-based SharePoint system to generate electronic document flow to enhance efficiency for routing and review and establish metrics for each document- Supported the implementation and data migration of documents into the new DCA system.- Successfully transitioned third party manufacturing (TPM) document approval process from a paper-based system into the electronic Document Control and Archiving (DCA) system.

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 objectives while conforming with organization goals and finding the most beneficial way to achieve them- Accommodated the needs of the organization during periods of intense pressure and tight timelines by coordinating, managing and guiding projects in the appropriate direction in order to fulfill the necessary requirements of the deadline in a timely manner- Demonstrated confidence and commitment in achieving the highest level of accuracy and consistency within the department- Maintained a work style which was flexible, confident and ambitious with a desire to become more valuable to the organization