Sharon Blair

Senior Project Manager at Sequoia Consulting Group,LLC
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Contact Information
us****@****om
(386) 825-5501
Location
San Diego County, California, United States, US

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Experience

    • United States
    • Biotechnology Research
    • 100 - 200 Employee
    • Senior Project Manager
      • May 2021 - Present

      San Diego, California, United States Project Management consultant providing solutions, support, collaboration, and leadership to pharma/biotech business partners. Projects include: • Facilitating and managing complex Information Management (IM) and Clinical Supply Chain (CSC) projects for pharma/biotech business partners. • Collaborating with client cross-functional teams and external software vendor to implement integrated, validated cloud-based clinical supply chain platforms to include forecasting; planning… Show more Project Management consultant providing solutions, support, collaboration, and leadership to pharma/biotech business partners. Projects include: • Facilitating and managing complex Information Management (IM) and Clinical Supply Chain (CSC) projects for pharma/biotech business partners. • Collaborating with client cross-functional teams and external software vendor to implement integrated, validated cloud-based clinical supply chain platforms to include forecasting; planning, manufacturing, and distribution; and returns, accountability, and reconciliation of clinical supplies in support of client’s clinical trials. • Integrated platform minimizes manual processes and un-validated record and documentation systems, thereby improving CSC efforts and records management and compliance. • Clarifying project team R&R’s; defining processes, activities, and timelines; and developing and managing project plans and budget. • Facilitating lab and testing readiness activities of new biopharma labs for Precision Oncology business partners. Managing site enablement and site qualification activities to help ensure lab is prepared for CLIA/CAP certification/accreditation. Show less

    • United States
    • Biotechnology Research
    • 1 - 100 Employee
    • Senior Clinical Project Manager
      • Oct 2019 - May 2021

      Carlsbad, CA Maintained responsibilities as Project Manager position below, with additional responsibilities in: • Led and coached direct reports, responsible for hiring, onboarding, training, and development. • Partnered with generation of proposals and statements of work in collaboration with Business Development, Finance, Legal, and appropriate Lab Operations teams, and maintained project financial forecasts and budgets. • As Project Lead for specific projects, established and oversaw project… Show more Maintained responsibilities as Project Manager position below, with additional responsibilities in: • Led and coached direct reports, responsible for hiring, onboarding, training, and development. • Partnered with generation of proposals and statements of work in collaboration with Business Development, Finance, Legal, and appropriate Lab Operations teams, and maintained project financial forecasts and budgets. • As Project Lead for specific projects, established and oversaw project plans in collaboration with cross-functional teams, defining R&R’s, setting deliverables, managing activities, and ensuring timely and accurate completion of project milestones. • Provided timely updates to management, key project stakeholders, and Sponsors, including metrics, trends, and issue resolution. • Evaluated project and team performance, recommended improvements by indentifying root causes and implementing “lessons learned”.

    • Clinical Project Manager
      • Jun 2017 - Oct 2019

      Carlsbad, CA • Onboarded, launched, and managed biomarker and diagnostic testing supporting Sponsor oncology clinical trials • Served as internal expert on multiple trials supporting breast cancer, pediatric brain cancer, and melanoma. Including several trials with highly complex testing workflows and pivotal timelines for business critical Sponsor trials supporting regulatory submissions. • Authored study-specific documents, work instructions, led team meetings, prepared meeting minutes, and… Show more • Onboarded, launched, and managed biomarker and diagnostic testing supporting Sponsor oncology clinical trials • Served as internal expert on multiple trials supporting breast cancer, pediatric brain cancer, and melanoma. Including several trials with highly complex testing workflows and pivotal timelines for business critical Sponsor trials supporting regulatory submissions. • Authored study-specific documents, work instructions, led team meetings, prepared meeting minutes, and proactively resolved issues, ensuring effective teamwork cross-functionally to drive projects and make sure deliverables were met per project timelines. • Tracked biological specimens received for assigned trials, communicated and urgently resolved any specimen issues with clinical sites and CRO’s, and ensured all testing was completed to meet project milestones. • Reviewed data transfer files to assist the data team in delivering quality data per the data transfer specifications and project requirements. • Resolved and responded to data queries from Sponsor’s data management team, and coordinated internal data reconciliation. • Maintained Investigator Site File, coordinated and submitted study packages to IRB, and coordinated and managed Monitoring Visits with CRA’s in support of Companion Diagnostic (CDx) trials. • Collaborated with QA on internal study audits and CDx monitoring visits to ensure all quality requirements were met • Prepared for and participated in successful FDA BIMO and EMA inspections for CDx trial. • Trained and mentored associate project managers, providing feedback to the associate, as well as their managers, on performance and development. • Managed assay transfer project in preparation for potential IDE submission to support an upcoming new Phase 3 trial. Established the project plan and timelines, and responsible for driving collaboration with manufacturing, lab, quality, and regulatory activities, within a RACI matrix, to achieve milestones and deliverables.

    • United Kingdom
    • International Trade and Development
    • 700 & Above Employee
    • Senior Client Services Project Manager
      • Sep 2016 - Jun 2017

      Greater San Diego Area Manage and mentor 7 direct reports • Built a team of four Client Service Project Managers (CSMs) from scratch. Responsible for their hiring, onboarding, and training, as well as developing the CSMs into a fully productive team critical to client satisfaction and business success. • Serve as main point of escalation for immunochemistry lab issues, specifically related to timelines, scheduling, resource allocation • Build and maintain strong and effective team dynamics and morale, and… Show more Manage and mentor 7 direct reports • Built a team of four Client Service Project Managers (CSMs) from scratch. Responsible for their hiring, onboarding, and training, as well as developing the CSMs into a fully productive team critical to client satisfaction and business success. • Serve as main point of escalation for immunochemistry lab issues, specifically related to timelines, scheduling, resource allocation • Build and maintain strong and effective team dynamics and morale, and foster a positive and productive cross-functional team environment • Work with the CSMs and project teams to facilitate team preparation for key client calls and meetings, and other governance-type client events. • Key member of site leadership team, coordinating communication across the company to engage key stakeholders with a solution-oriented, proactive focus. • Translate project strategies into operational plans to ensure activities are aligned with timelines and deliverables, and plan accordingly/anticipate contingency events. • Proactively identify resource allocation gaps to avoid program timeline delays. • Implemented 3 new processes to improve operations’ ability to meet timelines: lab scheduling, QC/QA scheduling, and issue escalation. • Built a contracts team of three Proposal Coordinators who are responsible for writing all quotes, statements of work, and RFP’s for both immunochemistry and LCMS labs. • Responsible for reviewing and approving contracts and making key decisions on pricing for current service offerings in addition to establishing pricing for new service offerings. • Work closely with the Director of Business Development to improve processes and communications between the Business Development Managers and Proposal Coordinators. • Spearheaded improvements with quote templates to create more concise contract terms to minimize revenue that was being lost through “gray” areas of the contracts, and also add revenue to T&C’s where revenue was not being captured.

    • Client Services Project Manager
      • Apr 2016 - Sep 2016

      Greater San Diego Area •Navigated unchartered territory in this brand new Client Services Project Manager position, for which there was no established training plan, by engaging with key personnel and developing this position from the ground up, resulting in improved client satisfaction as well as operational and customer service excellence •Served as the single POC for over 15 pharmaceutical clients, ranging from 1-20 projects per client, including overseeing one of Intertek’s Top 3 largest clients with over 30… Show more •Navigated unchartered territory in this brand new Client Services Project Manager position, for which there was no established training plan, by engaging with key personnel and developing this position from the ground up, resulting in improved client satisfaction as well as operational and customer service excellence •Served as the single POC for over 15 pharmaceutical clients, ranging from 1-20 projects per client, including overseeing one of Intertek’s Top 3 largest clients with over 30 active preclinical and clinical studies, with some studies analyzing multiple drug products oProjects included PreClinical and Clinical Method Development and Validation activities and Sample Analysis, mostly in Immunochem bioanalysis (some in LCMS BA) •Led client TCs and F2F meetings and assisted with technical discussions, troubleshooting, and coordination of timelines. Maintained project documentation files including presentations, meeting agendas/minutes, and action items •Prepared and maintained Project Trackers to manage project schedules, deliverables, and scope of work •Provided persistent and proactive follow up with colleagues on projects, while maintaining tact and professionalism •Identified impediments to team effectiveness and provided solutions •Ensured effective teamwork cross-functionally to drive projects and make sure deliverables were met per client timelines, and communicated any delays immediately to the client •Excellent written and verbal communication skills, organizational skills, sound decision making, and ability to adapt quickly to change and work both independently and with a team in a highly fast-paced environment •Managed project budgets, including scope/changes, budget vs. actual costs, and forecasting. Worked with the Finance Team to ensure project invoices were accurate and timely •Key driver of process improvements, including weekly scheduling of operations resources, revenue forecasting to HQ, and monthly invoicing for labwork performed

    • Scientific Account Manager
      • Apr 2015 - Apr 2016

      Greater San Diego Area • Created quotes and proposals for sponsor’s bioanalytical studies, followed up quotes to close sales and drive repeat business. • Developed a solid understanding of pre-clinical and clinical trial protocols in order to extrapolate required information and effectively communicate questions to clients for quote and scope of work generation. • Mastered a technical understanding of bioanalytical assays, both immunochemistry (PK/ADA/NAb) and LCMS, enabling clear and concise scientific… Show more • Created quotes and proposals for sponsor’s bioanalytical studies, followed up quotes to close sales and drive repeat business. • Developed a solid understanding of pre-clinical and clinical trial protocols in order to extrapolate required information and effectively communicate questions to clients for quote and scope of work generation. • Mastered a technical understanding of bioanalytical assays, both immunochemistry (PK/ADA/NAb) and LCMS, enabling clear and concise scientific dialog with clients during proposal generation. • Took responsibility as the Account Manager for one of Intertek’s Top 3 largest clients, after only 4 months of employment, with over 30 active pre-clinical and clinical studies, some studies analyzing multiple drug products. o Created a system to organize all the quotes/scope of work and PO’s (>130) for their studies for ease of real-time tracking by Principal Investigators and Project Coordinators o Eliminated the client’s bad debt from affecting the PnL, through diligent follow-up on outstanding payments. • Managed over 20 additional clients with multiple projects/studies per client. • Maintained Work In Progress (WIP) spreadsheets to ensure that all contracted work and revenue was captured, and reconciled the WIP at month-end to verify all invoiced revenue was accurate to the WIP revenue. o Organized a training system to train new Project Coordinators responsible for updating the WIP • Worked with Principal Investigators and Finance colleagues to create nominations for invoicing. o Took on a leadership role in driving the nomination approval process each month to ensure all invoicing met the company’s monthly revenue goal ($1.2-$1.4M per month). o Initiated and delegated a system to improve the approval process that improved the end-of-month workflow for the Finance Team • Regularly communicated with clients via email, phone, and conference calls. • Responsible for understanding and following GLP guidelines and laboratory SOPs.

    • Health, Wellness & Fitness
    • 1 - 100 Employee
    • Business Development Executive
      • Sep 2013 - Jan 2015

      Greater San Diego Area I own a home-based franchise of a fast-emerging health, nutrition, and wellness business. • Develop and manage relationships to create growth, sales, and new business for my company. • Develop effective working relationships with customers and other distributors on my team through regular meetings, and identify and obtain further sales and business development opportunities. • Recruit, mentor, lead, and help others develop their own successful home-based franchise coaching… Show more I own a home-based franchise of a fast-emerging health, nutrition, and wellness business. • Develop and manage relationships to create growth, sales, and new business for my company. • Develop effective working relationships with customers and other distributors on my team through regular meetings, and identify and obtain further sales and business development opportunities. • Recruit, mentor, lead, and help others develop their own successful home-based franchise coaching businesses. • Design marketing campaigns to support generating new business and raising awareness of other company products. Show less

    • Owner, Fitness Trainer, Nutrition and Health Coach, Business Development
      • Sep 2013 - Jan 2015

      Greater San Diego Area High-Performance Training for Life and Sport - www.22s.com/sabfitness, • Used physiological, biochemical, and exercise science principles to deliver effective and creative exercise and nutrition programs for individuals and groups. • Grew business through social media and internet marketing and strong relationship building and referral program. • Developed leadership through coaching 65 clients with a variety of fitness, nutrition, weight loss, and athletic goals. • Designed and… Show more High-Performance Training for Life and Sport - www.22s.com/sabfitness, • Used physiological, biochemical, and exercise science principles to deliver effective and creative exercise and nutrition programs for individuals and groups. • Grew business through social media and internet marketing and strong relationship building and referral program. • Developed leadership through coaching 65 clients with a variety of fitness, nutrition, weight loss, and athletic goals. • Designed and implemented a creative, 25-minute workout video membership group, easily accessed online, with results-focused workouts all fitness levels can fit in even on the busiest of days. Show less

    • Technical Sales Representative
      • Oct 2011 - Jun 2013

      Oceanside, CA • Responsible for product, industry, and competitor knowledge and full understanding of sales process to bring new prospects to customers and increase revenue with existing customers. • Educated customers via phone, email, in-person meetings, and group presentations on a technical, innovative product line of consumables for tissue culture, molecular biology, analytical sciences, DMPK, medicinal/synthetic chemistry, medical devices, genomics, FDA, and food/nutraceuticals. • Developed a… Show more • Responsible for product, industry, and competitor knowledge and full understanding of sales process to bring new prospects to customers and increase revenue with existing customers. • Educated customers via phone, email, in-person meetings, and group presentations on a technical, innovative product line of consumables for tissue culture, molecular biology, analytical sciences, DMPK, medicinal/synthetic chemistry, medical devices, genomics, FDA, and food/nutraceuticals. • Developed a working knowledge of protein and antibody expression from bacterial, mammalian, and insect cell lines, including ELISA and other analytical biochemistry assays. Also biological HPLC and LCMS analysis and purification in both discovery and production phases. • Managed $1.2 million territory of Southern California and Arizona and other assigned out-of-territory customers. • Developed accounts and client relationships to increase revenue in new and current customers through phone calls, email, networking, vendor shows, and strategic account management and follow-up using ACT CRM. • Assisted Product Development in bringing three new products to market through working with customers on beta-testing and providing results to engineering colleagues. • Represented company at national trade shows to help grow overall business and provided technical and scientific input to the marketing team. Show less

    • Wellness and Fitness Services
    • 100 - 200 Employee
    • Personal Trainer and Group Exercise Instructor
      • Oct 2010 - Oct 2011

      Greater San Diego Area Designed workout programs for both individuals and small groups Consistently among top 3 trainers and group instructors in monthly sales revenues and class attendance

    • Wellness and Fitness Services
    • 1 - 100 Employee
    • Wellness Account Manager
      • Sep 2007 - Aug 2010

      Greater Boston Area • Managed 3 corporate fitness centers and wellness accounts in the industries of medical devices, thermal/infrared and visible-light imaging systems, and audio/video technology. • Oversaw group exercise program, including scheduling, supervising instructors, and processing monthly payroll. • Managed administrative functions, provided equipment orientations, fitness assessments, and personalized exercise programs. • Taught classes on fitness/wellness topics such as Strength and Core… Show more • Managed 3 corporate fitness centers and wellness accounts in the industries of medical devices, thermal/infrared and visible-light imaging systems, and audio/video technology. • Oversaw group exercise program, including scheduling, supervising instructors, and processing monthly payroll. • Managed administrative functions, provided equipment orientations, fitness assessments, and personalized exercise programs. • Taught classes on fitness/wellness topics such as Strength and Core Training, Packing a Healthy Lunch • Prepared quarterly reports for clients regarding employee participation in services. • Several key activities included - o Coordinated all aspects of annual Fitness Olympics; included promoting program and registering 185 employees worldwide, creating a scoring system for 37 teams, motivational tips, etc. o Led an 8-week workplace weight loss program for 15 members; included weekly meetings, weigh-ins, and workout sessions. o Coached eight, 4-person teams to their weight loss goals in “Biggest Loser” workplace program; winning female lost 10 pounds (6.3% of bodyweight) and winning male lost 26.5 pounds (12.1% of bodyweight). Show less

    • Owner / Group Exercise Instructor / Personal Fitness Trainer
      • Jan 2005 - Aug 2007

      Dexter, Michigan Provided personal fitness training and group exercise instruction for individuals, businesses, and organizations. Managed budgeting, marketing, sales, advertising, and promotions. Designed and delivered individualized strength and cardiovascular fitness programs for clients. • Served as Strength & Core Training Instructor for city’s community education program. • Served as Assistant Coach for Ann Arbor Track Club; helped lead and instruct a 10-week walking/running class to prepare 130… Show more Provided personal fitness training and group exercise instruction for individuals, businesses, and organizations. Managed budgeting, marketing, sales, advertising, and promotions. Designed and delivered individualized strength and cardiovascular fitness programs for clients. • Served as Strength & Core Training Instructor for city’s community education program. • Served as Assistant Coach for Ann Arbor Track Club; helped lead and instruct a 10-week walking/running class to prepare 130 women for a local 5K race. • Coached participants through indoor cycling workouts at Balanced By Fitness, Dexter, MI Show less

    • United States
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Senior Associate Scientist
      • Nov 2000 - Jun 2004

      Ann Arbor, MI • Designed experimental approaches and synthetic routes with minimal supervision to prepare compounds to support drug discovery efforts in the Antibacterial Therapeutic Area. • Routinely implemented parallel synthesis techniques to efficiently synthesize targets. • Purified reaction mixtures and final compounds using standard and reverse phase column chromatography. • Presented research results at team meetings; contributed experimental expertise for 3 US Patent… Show more • Designed experimental approaches and synthetic routes with minimal supervision to prepare compounds to support drug discovery efforts in the Antibacterial Therapeutic Area. • Routinely implemented parallel synthesis techniques to efficiently synthesize targets. • Purified reaction mixtures and final compounds using standard and reverse phase column chromatography. • Presented research results at team meetings; contributed experimental expertise for 3 US Patent Applications. • Utilized a variety of analytical techniques, including FTIR, 1H and 13C NMR, GCMS, LCMS, and HPLC, to analyze the purity and identity of compounds. • Responsible for keeping database inventory of the key starting materials for the entire project team. • Managed data and used understanding of reaction mechanisms to troubleshoot experimental results. Show less

    • United States
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Associate Scientist
      • Oct 1999 - Nov 2000

      Indianapolis, Indiana Area • Designed synthetic routes with minimal supervision to prepare compounds to support drug discovery efforts in the CNS Therapeutic Area. • Routinely implemented parallel synthesis techniques to efficiently synthesize targets. • Presented experimental and intellectual expertise at team meetings. • Used appropriate analytical techniques, including FTIR, 1H and 13C NMR, GCMS, LCMS, and HPLC, to analyze the purity and identity of compounds. • Used standard and reverse phase column… Show more • Designed synthetic routes with minimal supervision to prepare compounds to support drug discovery efforts in the CNS Therapeutic Area. • Routinely implemented parallel synthesis techniques to efficiently synthesize targets. • Presented experimental and intellectual expertise at team meetings. • Used appropriate analytical techniques, including FTIR, 1H and 13C NMR, GCMS, LCMS, and HPLC, to analyze the purity and identity of compounds. • Used standard and reverse phase column chromatography to purified reaction mixtures and final compounds. Show less

Education

  • CRA Training Institute
    Clinical Research Associate Certification, Clinical Research
    2016 - 2018
  • University of California, Irvine
    Master of Science, Organic Chemistry
    1997 - 1999
  • Hillsdale College
    Bachelor of Science, Chemistry
    1993 - 1997

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