Gina Brower, Pmp®

Gina Brower, Pmp® Email and Phone Number

Laboratory Program Manager @ Universal Diagnostics S.A.
United States
Gina Brower, Pmp®'s Location
Austin, Texas Metropolitan Area, United States
Gina Brower, Pmp®'s Contact Details
About Gina Brower, Pmp®

Please contact me at g.brower16@gmail.com with Senior-Level Program/Project Manager or Lab Operations Manager opportunities within the diagnostics and biotech environments. Skilled in fostering collaborative partnerships with stakeholders at all levels of an organization, adeptly overcoming obstacles to drive impactful solutions and operations forward. Certified Project Management Professional – PMPCAREER HIGHLIGHTS:~ I managed one of the most complex clinical trials that involved multiple therapeutic agents, internal & external business partners, and alliance managers. The study was successfully initiated and clinical supply arrived on site so the first patient enrolled as planned.~ I created and drove a program management initiative to increase transparency and ease burdens between the cross-functional core teams and executive management while strengthening project management processes.~ I liaised between internal stakeholders and external clients and achieved a 98% client satisfaction rating for CRO specialty lab services.~ I coordinated a cross-functional software implementation project to use JIRA, Confluence, and Smartsheet for sample and data management which drastically improved collaboration and work progress between engineers and scientists.~ I established a good laboratory practice (GLP/GxP) environment with automation, development, production, QA and training groups to ensure compliance with document control and lab/sample processes, equipment, regulatory guidelines, and safety for a biosafety level (BSL2) laboratory for vaccine work.~ In a clinical testing laboratory, successfully developed, troubleshot, and validated bioanalytical immunoassays, cell-based assays, ligand-binding assays, and molecular endpoint (RT-PCR) assays for Phase 1, 3, and 4 vaccine trials.~ I was awarded for leading, collaborating, managing, supporting, and training cross-functional Yellow Belt Lean teams that identified best practices and achieved operational excellence (~110 people trained and ~90 projects completed in three years).

Gina Brower, Pmp®'s Current Company Details
Universal Diagnostics S.A.

Universal Diagnostics S.A.

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Laboratory Program Manager
United States
Gina Brower, Pmp® Work Experience Details
  • Universal Diagnostics S.A.
    Laboratory Program Manager
    Universal Diagnostics S.A.
    United States
  • Conjugate Group
    Drug Development Project Manager
    Conjugate Group Aug 2024 - Present
  • Bill & Melinda Gates Medical Research Institute
    Pm Consultant For Program And Portfolio Management
    Bill & Melinda Gates Medical Research Institute 2021 - 2023
    Cambridge, Massachusetts, United States
    Successfully completed a 2-year contract at Bill & Melinda Gates Medical Research Institute through Logix Inc talent acquisition firm.~ Partnering with the Product Development Team (PDT), Clinical Trial Team (CTT), partners, alliance managers and CRO, identified and mitigated programmatic challenges and risks to ensure adherence to timelines, contracts, budgets and regulatory requirements.~ Successfully met the project target date for a clinical trial by coordinating and communicating with internal and external Regulatory sub-team members, vendors, and CRO to ensure appropriate documents for regulatory filings in low/middle-income countries were filed.~ Liaising with Legal and non-profit & industry partners on clinical supply agreements (CSA), coordinated shipment from CDMO to pack/label/distribute clinical trial material for delivery to depots/clinical sites using Global Gateway and Suvoda IRT for study startup.~ Created Planisware project templates and plans for Clinical Supply to effectively communicate project status and updates to key stakeholders and senior management, ensuring transparency and alignment.
  • Asuragen
    Project Manager
    Asuragen 2018 - 2021
    Austin, Texas Area
    ~ Worked with project leaders from R&D, MarComm, QA, Regulatory, Design Transfer, Bioinformatics, Biostatistics, Software, and Manufacturing to achieve commercialization objectives for oncology & rare genetic disorders by identifying resources, coordinating and facilitating cross-functional communication and collaboration, and developing and maintaining schedules to hit key milestones. ~ Led a Design Control (ISO 13485 and 21 CFR 820) documentation initiative to revise New Product Development SOPs and forms to better reflect and streamline the process from discovery to development to commercial launch.~ Coordinated a building consolidation project with facilities to integrate CLIA, Development and Manufacturing into cubicle and laboratory areas, completing one month ahead of the corporate goal.~ Created and organized a program management initiative to increase transparency and ease burdens between the cross-functional core team and executive management while strengthening project management processes.
  • Precision For Medicine
    Senior Project Manager
    Precision For Medicine 2016 - 2018
    San Francisco Bay Area
    ~ Managed 30+ early research timelines, deliverables, resource plans, reagent procurement, and project scope with laboratory staff. ~ Worked closely with Business Development/Finance to track opportunity status in Salesforce from request for proposal (RFP) through award, and smoothly transition projects to PM once contracts were approved. ~ Evaluated contract/project budgets monthly, initiated change orders, performed periodic resource gap analysis and reported unexpected variances to senior management to project future trends related to cost, completion time, and resource needs.~ Liaised between internal stakeholders and external clients and achieved a 98% client satisfaction rating for CRO specialty lab services and biomarker assays.
  • Natera
    Laboratory Operations Manager
    Natera 2015 - 2016
    San Francisco Bay Area
    ~ Recruited and led a team of 14 employees to perform cell culture, lab services, clinical sample management, and blood/tissue DNA extraction for NGS runs.~ Monitored Clinical Trial, Engineering, and R&D Lab Operations timelines to align interdepartmental initiatives to support cell-free DNA NGS testing, dedicated to oncology and women’s health. ~ Led R&D’s LabVantage LIMS implementation project for sample management (biobanking) and equipment. Managed tracking and logistics for biological specimens from collection to analysis for scientific staff. ~ Actively collaborated with IT, Clinical Laboratory Improvements Amendments (CLIA) Operations, Clinical Trial Operations, Engineering, Process Development, and QA to implement HIPAA/ICH/GCP/GLP to ensure alignment with regulatory standards.~ Led a cross-functional software implementation project for sample and data management in JIRA, Confluence, and Smartsheet that drastically improved collaboration and work progress between engineers and scientists.
  • Strive2B Coaching
    Leadership And Health Coach
    Strive2B Coaching 2013 - 2015
    United States
    Empowering people to develop healthier relationships with themselves and others in all aspects of their life. Gallup CliftonStrengths and Institute for Integrative Nutrition (IIN) concepts are utilized in coaching sessions.
  • Aviron (Acquired By Medimmune / Astrazeneca)
    Clinical Testing Laboratory Manager
    Aviron (Acquired By Medimmune / Astrazeneca) 2006 - 2012
    San Francisco Bay Area
    ~ Providing expertise to a cross-functional Clinical Operations team, successfully managed and completed assay development and sample testing for Translational Sciences vaccine early research phase, preclinical and clinical trials (Phase 1, 3 and 4) within budget, scope and schedule.~ Established a good laboratory practice (GLP/GxP) environment with automation, development, production, QA and training groups to ensure compliance with document control and lab/sample processes, equipment, regulatory guidelines, and safety for a biosafety level (BSL2) laboratory for vaccine work.~ Successfully developed, troubleshot, and validated bioanalytical immunoassays, cell-based assays, ligand-binding assays, and molecular endpoint (RT-PCR) assays for Phase 1, 3, and 4 trials.~ Awarded for leading, collaborating, managing, supporting, and training cross-functional Yellow Belt Lean teams that identified best practices and achieved operational excellence (~110 people trained and ~90 projects completed in three years).~ Met regularly with 8-24 contract and regular employees to evaluate performance and assess goals, progress, personnel and lab issues, and professional career development.

Gina Brower, Pmp® Skills

Cross Functional Team Leadership Leadership Biotechnology Assay Development Team Building Cell Culture Project Management Coaching Quality Assurance Operational Excellence Process Improvement Strategic Planning Mentoring Training Operational Streamlining Change Management Life Sciences Biopharmaceuticals U.s. Food And Drug Administration Glp Validation Clinical Trials Biochemistry Clinical Research Continuous Process Improvement Good Laboratory Practice Regulatory Compliance Good Clinical Practice Customer Relationship Management Data Analysis Resource Management Clinical Development Quality System Project Planning Program Management Research And Development Standard Operating Procedure Microsoft Office Microsoft Powerpoint Microsoft Word Microsoft Project Team Leadership People Development People Management Client Services Laboratory Safety Coaching And Mentoring Seven Habits Of Highly Effective People

Gina Brower, Pmp® Education Details

Frequently Asked Questions about Gina Brower, Pmp®

What company does Gina Brower, Pmp® work for?

Gina Brower, Pmp® works for Universal Diagnostics S.a.

What is Gina Brower, Pmp®'s role at the current company?

Gina Brower, Pmp®'s current role is Laboratory Program Manager.

What is Gina Brower, Pmp®'s email address?

Gina Brower, Pmp®'s email address is gm****@****hoo.com

What schools did Gina Brower, Pmp® attend?

Gina Brower, Pmp® attended University Of California, Davis.

What skills is Gina Brower, Pmp® known for?

Gina Brower, Pmp® has skills like Cross Functional Team Leadership, Leadership, Biotechnology, Assay Development, Team Building, Cell Culture, Project Management, Coaching, Quality Assurance, Operational Excellence, Process Improvement, Strategic Planning.

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