Project Coordinator Data Management
Resume:
Michele Holliday, MPM
Rolesville, NC *****
**********@*****.***
https://www.linkedin.com/in/mickey-d-holliday-mpm/
Experienced project and proposal leader with robust background in project implementation, project management, operational preparedness, educational presentations, and proposal writing. Proficient in process design, scope design, strategic planning, commercial strategy, technical and proposal writing, and database implementation. Expert at working with multidisciplinary teams to successful project execution while maintaining high standards of quality. Skilled in fostering collaborative relationships with stakeholders. Passionate about driving innovation and delivering results that positively impact business objectives.
Experience
JULY 2022 – FEBRUARY 2025
Proposal Writer (Remote) • Genezen, LLC • Indianapolis, IN
●Play a key role in Genezen’s growth from a 50-person, single-site operation that had yet to conduct a cGMP run to the successful opening of the GMP facility. Contribute to the company’s expansion into a multi-site organization, overseeing 80 cGMP commercial batch runs.
●Collaborate with SMEs, clients, and Business Development to design proposal scope detailing services, then prepare pricing and compose clear and compelling viral vector (RVV, LVV, AAV) proposals that address client needs and mitigate risks from development through cGMP commercial stages of cell and gene therapy
●Project manage the proposal process to meet deadlines by establishing target dates and prioritizing for information gathering, writing, review, and approval for multiple opportunities
●KEY PROJECTS/ACCOMPLISHMENTS:
oManage the planning and logistics of 16 annual conferences by facilitating biweekly meetings to strategize attendance and brand awareness for each including coordination of catered social events for select conferences to increase lead acquisitions
oFacilitated weekly product management meetings with marketing and executive leadership while monitoring and participating in sub-projects and marketing initiatives
oActed as project manager for website refresh project (supported by 3rd party web team) to improve focused customer messaging alignment in company website, marketing tools, CRM, and business development
OCTOBER 2021 – JULY 2022
Senior Proposal Writer (Hybrid) • Tergus Pharma, LLC • Durham, NC
●Hired, trained, assigned proposals, provided guidance to, and oversaw PDS proposal writers
●Collaborated with Business Development to enter, monitor, and track data into Microsoft CRM then later Salesforce
●Prepared weekly proposal reports for Senior Management
●KEY PROJECTS/ACCOMPLISHMENTS:
oTo facilitate the expansion of providing commercial manufacturing services, I gathered data and created an excel batch pricing tool which captured costs for manufacturing, packaging, testing, and stability studies
oComposed and maintained topical pharmaceutical proposal templates used for formulation development, clinical trials supply manufacturing, technology transfer, commercial manufacturing, IVRT, IVPT opportunities by working with SMEs, management, and executive team for guidance
AUGUST 2018 – OCTOBER 2021
Drug Product Commercial Quoting Specialist (Remote) • Patheon, a Division of Thermo Fisher Scientific, North American and EU Sites
●Created pricing and wrote commercial manufacturing proposals for multiple sites in North America and EU for oral solid dose, non-sterile liquids, soft-gels, and sterile pharmaceuticals
●Facilitated inbound opportunity conference calls to develop quote scope details and pricing with site management and varying levels of executive leadership worldwide
●KEY PROJECTS/ACCOMPLISHMENTS:
oWrote and maintained department process manual which standardized processes, expedited new hire training, and more efficiently updated and align staff on pricing and proposals processes
oSharepoint and Salesforce super user: regularly created and lead trainings for proposals team
NOVEMBER 2015 – AUGUST 2018
Systems Specialist/ Site Project Implementation (Remote) • Unity Lab Services (ULS), a Division of Thermo Fisher Scientific • North America
●Worked with varying implementation teams or alone to complete projects at customer sites to implement new or make changes to existing contracts involving stockrooms, inventory services, and/or lab supportive services.
●Utilized strong communication and technical writing skill for composing or updating standardized SOPs, Work Instructions, Workflow Diagrams and trained operational ULS employees that would remain after project completion
●Planned and implemented stockroom and point-of-sale design, performed inventory analysis, loaded databases, and managed and customized ordering system, including learning/teach client systems
MAY 2014 – OCTOBER 2015
Regional Site Specialist (Remote) • Unity Lab Services (ULS), a Division of Thermo Fisher Scientific • Southeastern USA
●Performed order entry, order management, operated customer procurement systems, stockroom services, material handling, shipping/receiving and chemical tracking
●Create or update existing work instructions/SOP/SOW, site audits and post coverage analysis
●Site implementation processes: train new employees or cross train existing, compose work instructions for future on-site and RSS to follow, help implementation team with site set up
●Stockroom/Warehouse duties: inventory/cycle counts, iRIMS reports, replenishment orders, receiving shipments, perform quality and safety audits
December 2011 - May 2014 • Medical Technologist • WakeMed Hospitals • Multi-Site
November 2010 - February 2011 • Laboratory Associate • Expression Analysis • Durham, NC
June 2009 - November 2010 • Clinical Laboratory Technologist • Duke University Health Systems • Durham, NC
August 2010 - November 2010 • Clinical Trials Assistant • Duke University School of Medicine • Durham, NC
Skills
Project Management • Proposal Management • Scope and Process Design • Project Pricing • Implementation • Operational Design • Educational Presentations • Training • Strategic Planning • Databases • Change Orders • Risk Management • Change Management • Advanced Microsoft Office Suite • Laboratory Information Systems • Pharmaceutical Development • cGMP • SOPs • Work • Instructions • Excellent time management skills • Conferences • Events • Public Speaking • SAP • Oracle
Education
AUGUST 2021 – AUGUST 2023
Master of Project Management/ Western Carolina University, Cullowhee, NC
AUGUST 2007 – JUNE 2009
Bachelor of Science Clinical Laboratory Sciences/Western Carolina University, Cullowhee, NC
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