William Planer Email & Phone Number

St. Louis, Mo, Us

Durham, North Carolina, Us

• Provides a range of leadership and influencing capabilities to achieve the business objectives and goals of clients• Responsible for the creation and execution of a project timelines plan covering all GDO deliverables (Data Management, Programming, Biostatistics)• Ensure the project is completed within budget, schedule, and according to contract specifications• Ensure the project is progressing according to quality standards, SOPs, ICH and/or other guidelines to fulfil regulations• Provide input to proposals and attend Bid Defense meetings• Participate in meetings with Business Development/CDD/PL/PM to understand the scope of the contract and any Master Service Agreement in place for the client• Oversee and Review information required for the project tools, project plan, TMF, EDC, and resourcing in collaboration with the PL/PM.• Accountable for the deliveries from the technology/data integration team.• Provide leadership and direction to the project team members• Record and measure progress of the study against project plans to mitigate risk and ensure updates are made accordingly• Perform early risk mitigation, identifying areas of potential problems providing input into Risk Management Plan• Track resources and time spent on each project task for all team members to evaluate project progress and productivity• Implement and instigate process improvements within the project• Work with functional experts to track scope of ongoing work to identify changes in scope.• Prepare, participate in, and follow up on audits/inspections/QIs• Maintain a working knowledge and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements, SOPs, and study specific procedures

St Charles, Mo, Us

Principal clinical project manager for new and existing global customers. Manages project flow from project initiation through closeout while monitoring study for contractual adherence. Provides guidance to Business Development and writes/reviews all contacts, change orders, and bid defense . Guides resource scheduling, FTE allocation, contributes to company forecasts, and revenue recognition based on project specifications and timelines.Provides guidance and reviews, clinical protocols, site kits for sample collection and lab manuals for sponsors.Reviews Bioanalytical sample analysis/development/validation data (PK,PD, anti-drug antibodies, Biomarkers). Oversees, reviews, and edits validation, qualification, and final Bioanalytical reports for GCP studies and reports.Directs client data management, Sample management, and Sample analysis plansAssures the quality of the data and compliance with applicable SOPs and regulatory requirements.Applies GxP (GLP/ICH/GCP) in all areas of responsibility and provides guidance on analytical issues, project technical requirements, design and logistics for all clinical trial phases.Designs and improves processes and procedures to increase efficiency, productivity, and qualitySupports client auditsWrites and reviews company SOPs

St. Louis, Missouri, Us

Leads performance improvement activities and new assay validations--both FDA approved assays and Laboratory Developed Tests.Provides guidance to scale up laboratory operations to three shifts to handle the Covid-19 pandemic testingMethod development and validation of FDA compliant diagnostic qPCR assays under CLIA/CAP regulations. Identify and deliver technical advice on equipment including quality control, malfunctions and abnormal patient results. Provides training for new laboratory personnel in methods, procedures and use of equipment and instruments specific to the assigned area. Communicates directly with the Director of Pathology to clarify testing questions including specimen type, stability, quality, and methodology. Using six sigma principles to decrease the number of rejected samples by improving the robustness of approved assays. Using six sigma principles to transform lab protocols into high throughput assays.

Us

Hematology 2018 to 2020, Managed $500,000 in capital funds.Led the design and capital equipment purchase for SLU departmental tissue culture room. Worked with the Institutional Review Board (IRB) to develop and oversee translational medicine projects. Write/review RFP and contract proposals for CRO'sPartnered with SLU care and SSM to create more effective rule in/rule out procedures for lower respiratory isolation in the ICUPartnered with SLU care and SSM to create a covid screening procedures for employeesLed in the development and characterization of Nanobodies as an anti-thrombotic therapeutic. Oversaw small Biologic production and protein purification. From vector design to CHO expression to AKTA pure systemsLed the development of ELISA, SPR detection, and characterization of the SARS-CoV-2 (Covid-19) - β2-glycoprotein 1 coagulation phenotype.

St. Louis, Mo, Us

Under a DEA Research license: Lead, Mentor, and train Departmental technicians, graduate students, Fellows, and postdoctoral candidates in all phases of their projects. Served as the liaison between four different departments: Obstetrics, Anesthesiology, Microbiology, Pediatrics. Led the design, renovation, and capital equipment purchase for the three Department of Anesthesiology departmental laboratory spaces totaling over 10,000 sqft $2,500,000. Led the design, renovation, and capital equipment purchase for two WASHU departmental tissue culture rooms. Oversaw the design and creation of space for the Department of Anesthesiology 1,500 sqft imaging center. As well as, lead the negotiations and proposals for the purchase of a 1.3 million dollars in capital equipmentManage vendor relationsWorked with the Institutional Review Board (IRB) to develop and oversee translational medicine projects. Write/review RFP and negotiate contract proposals/pricing for CRO'sPartnered with Washing University physicians to reduce the cost of uropathogenic E. coliPartnered with Washing University physicians to find new pain management procedures using epiduralsWrote expense justifications for capital equipment procurement and timesheet management. Managed the Anesthesiology protein purification core. Oversaw viral and plasmid vector design. Mammalian expression systems (expi293, HEK293, CHO). Purification protein A/G, Nickel, Size exclusion (SEC) Responsible for all regulatory requirements including writing and enforcing Institutional Biological and Chemical Safety Committee Protocols (IBC), Animal Studies Protocols, IACUC inspections, and Environmental health and Safety guidelines.

St. Louis, Missouri, Us

Oversee the development of monoclonal and polyclonal antibodies for GLP environmentWorked in small teams in a FDA GLP/GMP environmentMethod development and validation of assays for global regulatory approval of products. Quality Control reviewer for all study material published. Acted as process improvement specialist to streamline SOPs for high throughput use. Internally published validation and study SOPs.

St. Louis, Mo, Us

Conducted research on the downstream differentiation of neural crest stem cells (NCSC) and certain diseases caused by defects in NCSC in culture. Worked with and transfected DRG primary cells and NT2 cells. Lab responsibilities included managing four lab projects and the purchasing, equipment, and personnel necessary to keep the projects on schedule. Develop and troubleshoot PCR, Tissue/Cell/Organ Culture, and IHC/ ICC protocols. cellular and protein gene identifications using PCR, Western Blot, Histological and ELISA techniques.

Mba, Business Administration And Management, General

Masters In Finance, Finance, General

Masters Of Science, Cellular Molecular Biology

Graduate Level Certification, Biotechnology

Bachelors Of Science, Biology