Wendy L. Kendrick

** ***** **** **.

Sutton, MA *1590

978-***-****

ad0tca@r.postjobfree.com

TECHNICAL/COMPUTER KNOWLEDGE

Microsoft Office, Visio, SharePoint (Project Web App, Compass), Adobe, Pilgrim, CAD, Oracle, LIMS, Pyramidion/Sciforma, Skype, SDLC, Teams

GMP/GxP/SaaS, DNA/RNA organic Synthesis & Purification: IEX Chromatography, Ultrafiltration/Diafiltration, Annealing, PEGylation, Freeze-drying; Root Cause Analysis, Risk Assessment, Operational Excellence (Post Event Reviews), Revenue Recognition, Budget reporting (external cost and FTE tracking, analysis & reporting)

SELECTED ACCOMPLISHMENTS

Facilitated, documented and assisted in the management of projects for both Regulatory and Clinical international teams for ongoing studies of Phase II and commercially approved pharmaceuticals.

Facilitated team meetings, timelines and budgets for internal IT projects (Software e.g.’s include PM MS Project/Sciforma & SharePoint; QA Pilgrim; and Finance TM1) from Discovery/Strategy & Design through Test phases, initial Launch and Post Implementation Evaluation/Lessons Learned. Included Budget and end of project review presentation to Senior teams.

Prepared and presented project updates at Senior Management Stage Gate Meetings and provided Finance with updated Invoicing and Revenue Recognition spreadsheets.

Mastered the use of MS Project 2010 Pro/Sciforma and Project Web App to generate resource loaded Gantts that are critical components in the Budgeting and Reforecast processes.

Managed a diverse client, with demanding third party consultants, through a challenging PPQ which led to a successful validation and multi-million dollar QUOTIF’s met.

Created strong, positive customer relationships that resulted in agreement to ship multi-million dollar API batches ahead of PPQ documentation closure and to provide Revenue Recognition letter during customer’s vacation allowing Avecia to meet its 2010 and 2012 fiscal year-end budgets.

Worked closely with the Clinical and Regulatory departments to track PV’s, establish budgets and timelines for the Phase III Clinical trial for Preeclampsia; additionally assisted in creating and maintaining the budget and timelines for the FVIIa Phase II Clinical trial

Led Internal/External project teams and associated vendors through Root Cause Analyses that established the identity of particles found in drug product, which preserved the GMP and Quality status of the batch all while maintaining a very positive customer relationship.

Authored/reviewed/approved technical GMP documents, such as BPR’s, SOP’s, Technical Development Protocols & Reports (TDP’s/TDR’s) for development, Tox, Phase I, II, III and PPQ activities

Developed Post Event Review/Operational Excellence Procedure which captured and communicated “Lessons Learned” from project close-outs with goals to minimize repeat mistakes and also to increase efficiencies. Also developed a generic oligonucleotide freeze-drying cycle through execution of a DoE study which is still in use today.

Managed multiple projects concurrently which could include process and analytical development; Stability; Tox, Phase I, Phase II, Phase III and PPQ manufactures, including participation in Tech Transfers at both Avecia and LFB-USA.

Collaborated with all departmental functions to organize and create a Master Project Gantt/Schedule for the start-up of a new manufacturing facility at Fresenius Kabi.

Worked closely with IT department (SDLC) to develop timelines and budgets for transition to Pilgrim, SAP, harmonization to MS Project, Sharepoint administrator

PROFESSIONAL EXPERIENCE

Pearson Development, LLC Sept2022-Present

Pearson Development, LLC is a privately owned property acquisition, rental and maintenance company based out of Sutton, MA.

Property/Project Manager

Creation and organization of all business related documents:

oTenant invoicing and notices

oFinancial spreadsheets

oGantt charts for tracking property project status/completion/budget

Tenant communication in a diverse cultural environment

Pfizer, Gladstone, NJ May 2022-Aug2022

Pfizer is an international pharmaceutical that has developed some of the world’s most impactful medicines and vaccines, including a best-selling over-the-counter pain reliever, a popular medicine for anxiety and panic disorder management, an erectile dysfunction treatment, a vaccine to help provide protection against COVID-19, and an oral COVID-19 prescription treatment for patients at high risk of progressing to severe COVID-19.

Project Manager (Contractor)

Remote position. Through Teams and online applications, worked with an International team to develop plans for transfer of commercial product to a new site in Puerto Rico

Performed kick-off for activities, including Risk Assessment, and created timeline and deliverables for successful implementation of the transfer plan

Updated PMO sites and communicated project status to Senior Team

Denison Pharmaceuticals, Lincoln, RI Oct 2020-Jan 2021

Denison Pharmaceuticals is a contract development, manufacturing, packaging and laboratory services company for over-the-counter (OTC), cosmetic and homeopathic products.

Project Manager (Contractor)

Managed clients and internal teams in OTC and Ointments – timelines & project executions

RTF, Risk assessments

Business Management – assisted in improving procedures for communication and identifying gaps and plans to create better efficiencies

Financial input to Business Development team on generation of proposals

Nitto Avecia, Inc, Milford, MA June 2019-Sep 2019

NITTO DENKO Avecia, Inc is an oligonucleotide contract manufacturing facility offering many services to support clients through various stages of process and analytical development and clinical trials, from Tox through PPQ/Validation.

Second Shift Oligonucleotide Purification Supervisor

Supervised & assisted purification operators in IEX Chromatography, Ultrafiltration/Diafiltration, Annealing, Freeze-drying and harvesting of various oligonucleotide compounds under GMP and aseptic conditions.

Conducted and documented investigations related to manufacturing operator errors (documentation or operation), equipment failures, or other unanticipated events.

Assisted in creation of GMP documentation (BPR’s, SOP’s, CAPA’s, TDP’s/TDR’s)

Scheduled daily activities within the purification suite to meet manufacturing deadlines and coordinated with QC, Engineering and QA.

Responsible for the Supervison of 6 purification operators.

First Light BioSciences, Bedford/Chelsea, MA Oct 2018-Jan2019

First Light BioSciences is a growing diagnostic company that is developing the Multipath technology for accelerated detection of hospital-associated infections so as to save patients’ lives with more rapid detection and treatments.

Program Manager (Contractor)

Met with various Department heads to review and update internal Gantt for activities related to assay, cartridge, IT and software development to develop timelines for 501k submission. Also scoped major activities and necessary predecessors for longer-term plans for future scale-up and launch.

Created two internal/external Milestone trackers using MS Word and Excel.

Fresenius Kabi, Canton, MA Dec 2017-Jan 2018 Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. As part of its global expansion, Fresenius Kabi has included another manufacturing site located in Canton, MA.

Project Manager (Contractor)

Worked closely with all Department heads to pull together and create a Master Project Gantt for activities related to the start-up of a new Manufacturing Facility.

Presented the Gantt to Senior team and again made live-edits.

Compiled and organized pre-existing documentation, met with all department leaders (QA, QC, Validation, Manufacturing) to create a Master Project Gantt/schedule

Presented, reviewed and revised draft schedule live with all department heads/Senior team

PMO – Managed multiple internal teams and experience included timeline creation/budget management.

LFB USA/rEVO Biologics, Framingham, MA June 2013-Jan 2017

LFB USA is a company within the LFB Group, a leading European biopharmaceutical company specialized in innovative biotherapies, marketing its medicinal products in more than 30 countries around the world. Within the LFB Group, LFB USA is a development, manufacturing and services provider to LFB S.A. in France and rEVO Biologics in the United States.

Project Manager

Drug Development/Drug discovery Project management including the budgeting, forecasting, and tracking of project timelines. Communicated project scope and timeline changes to the Senior team. Includes project transfers, process development activities and continued process monitoring.

Established and reported KPI’s to Senior team. Also established clear meeting minutes stating all Actions, Deliverables, RI’s and timelines.

Created and managed/organized the Sharepoint system.

Facilitated and/or attended all budgeting and reforecast meetings with other project managers, sponsors and teams and managed/tracked all project plan (Gantt) and Worksheet updates. Included WebEx or telecom meetings when key individuals were unable to be onsite.

Lead and organized internal Clinical team on BLA submission activities/timelines for FVIIa Phase II Clinical trial – included taking and distributing meeting minutes for RI’s and content associated with the BLA

Established and maintained budget/timelines for the Phase III Clinical trial for Preeclampsia .

Worked with Finance to ensure all project plans were published in PWA with the correct information to allow budget and reforecast reporting through TM1.

Assisted Project Managers, Sponsors, and project team members by advising where certain activities were budgeted and if not, found appropriate offsets to allow critical activities to occur.

Provided budget and reforecast reconciliation to Finance; included assisting Finance with several budget presentations that were requested by LFB SA (on time).

Attended Tech Transfer, Project Team and LFB USA Board meetings; assisting by documenting meeting minutes and offering technical feedback where requested.

Acted as PM Compass Administrator, uploading all Worksheets and budget Gantts to the site for easy company-wide access.

Worked collaboratively with a diverse group of individuals (PM’s, Sponsors, Manufacturing, Process Development, QA/QC, Regulatory and Clinical teams) to obtain, interpret and communicate project information, in development through product launch.

Gained technical knowledge from QC and Process Development teams on analytical methods used to analyze and interpret data generated from scientific experiments and CofA product analyses (e.g. IEX, HPLC, RP, Sequencing, etc.)

Participated in process transfer activities of a launched product to a secondary CMO.

Worked with IT to implement and update the Project Web Application (PWA). Acted as the PWA Administrator, uploading all project documentation (Worksheets, Meeting Minutes, Gantt Archives, etc.). Created user instructions for PWA and MS Project 2010 Pro

NITTO DENKO Avecia, Inc, Milford, MA March 2006-March2013

NITTO DENKO Avecia, Inc is an oligonucleotide contract manufacturing facility offering many services to support clients through various stages of process and analytical development and clinical trials, from Tox through PPQ/Validation.

Project Manager

Closely involved with Product/process/Drug Development activities for a variety of process and product phases (Tox, Phase I, Phase II, Phase III, PPQ /launch and continuous process monitoring/improvement). Included writing, reviewing and approving documentation associated with manufacturing and service documentation (e.g. TDP’s/TDR’s, SOP’s, BPR’s, CofA’s, etc.)

Facilitated internal team meetings and teleconferences/WebEx with customers to initiate, coordinate and track progress of project details throughout the life of a project.

Involved in multiple Technology Transfers for oligonucleotides – synthetic DNA/RNA/LRNA/PEGylated DNA. Good customer relations throughout.

Generated and distributed project plans, agendas and meeting minutes to organize and communicate critical path actions and information required to keep projects and teams on track/budget.

Tracked financial status of Manufacturing and Service projects including invoicing and revenue recognition and reported monthly to Finance.

Worked with Business Development in the generation and review of proposals and provided notification of any project scope changes in a timely manner (within 24hrs).

PMO - Facilitated Project, Safety and Risk Assessments, Root Cause Analyses, Stage Gate and Post Event Reviews, and communicated any risks and lessons learned to the Project Steering Committee. Updates given on a weekly basis, at minimum.

Managed multiple projects concurrently, including manufacturing to service projects (any analytical or process development activities, stability studies, sequencing, characterization, etc.).

Persuaded internal and external teams to reach amicable resolutions to complex situations, included CAPA’s that arise unexpectedly during GMP manufacturing campaigns.

Acted as liaison between internal and external teams and was key in helping with any conflict resolutions.

Worked with an array of International teams – including EU, France, Germany, Japan and Israel.

Abbott Bioresearch Center, Worcester, MA July 2004-December 2006

Abbott Bioresearch Center was a Biologics division of Abbott Labs that is a contract manufacturer of pharmaceutical products. Mainly Humira at this site, though also several early phase compounds as well.

Manufacturing Suite Coordinator

Organized, tracked and scheduled calibrations and preventative maintenance for all pieces of equipment within the fermentation and purification suites using the CAS system.

Completed investigations for equipment found to be out of tolerance, including impact assessments and root cause analysis.

Created strong working relationships with the operators, supervisors and managers within the suites, as well as the calibration and PM coordinators to ensure smooth operation.

Performed monthly safety assessments in the suites and reviewed cleaning/calibration log books to verify that the suites were operating under GMP conditions.

Generated labels using the LIMS system and submitted to QC for analysis.

Avecia Biotechnology, Inc, Milford, MA June 2001-July 2004

(Now NITTO DENKO Avecia, Inc.)

Oligonucleotide Purification Operator and Supervisor

Performed IEX Chromatography, Ultrafiltration/Diafiltration, Annealing, Freeze-drying and harvesting of various oligonucleotide compounds under GMP and aseptic conditions.

Conducted and documented investigations related to manufacturing operator errors (documentation or operation), equipment failures, or other unanticipated events.

Assisted in creation of GMP documentation (BPR’s, SOP’s, CAPA’s, TDP’s/TDR’s)

Promoted to Purification Supervisor after 1 year and supervised 4 direct reports.

Scheduled daily activities within the purification suite to meet manufacturing deadlines and coordinated with QC, Engineering and QA.

Completed IQ/OQ on the Bioprocess skid and performed a DoE study that resulted in creation of the generic freeze-drying cycle that is still used at Avecia today.

EDUCATION

Hartwick College, Oneonta, NY Aug 1997-May 2001

B.S in Biology

MS Project Certified

PMP scheduled for 2023

Contact this candidate