David Mclean Iii, Pmp Email & Phone Number

Paris, Fr

Manage the technology transfer of novel gene editing processes to the Raleigh cGMP facility for clinical/commercial production that will supply much needed therapies for cancer patients. Utilizing my 26 plus years of experience to support supply chain and project management functions for the company's growth and success.

Supplementing income through stock trading platforms. Supporting the growth and development of my homestead for God's Purpose and His Glory

New York, New York, Us

Successfully led and improved the Supply Chain department by reorganizing the group and building adequate resources in the areas of Logistics, ERP-SAP Business system, site planning, and compliance and obtained site leadership peer support.• Built a supply chain model for evaluating site capacity and utilization requirements that allowed the site leadership team to decide on future capital expansion projects resulting in a firm strategic roadmap for future site growth.• Recognized for successfully leading a team and working with a supply chain consultant group to evaluate site logistics needs and delivered a strategic plan with limited capital exposure by working toward an annual lease agreement on a new logistics center. • Sponsored a warehouse capacity expansion capital project from start to completion by significantly increasing the cold chain and ambient footprint.• Co-sponsor for the Gene Therapy and Vaccine tech transfer teams to communicate supply chain KPI's along with risk/mitigation strategies to Pfizer Executive leadership teams and successfully met all timelines and cost objectives.

New York, New York, Us

Promoted to this role and successfully led several multi-disciplinary technology transfer teams to bring vaccine clinical stage programs from development through Process Validation and met all prescribed timelines, cost, and quality objectives. • Delivered the transfer of three distinct vaccine programs to the site that resulted in obtaining high quality clinical trial materials and also successfully completed the process validations for all three programs.• Successfully motivated and influenced a cross-site team (includes R&D, Manufacturing, Technical Operations, Regulatory, Global Quality, etc.) to build and implement a robust system to the Co-Development model for transferring new products from early research to full scale production which resulted in a more consistent and clear tech transfer process.• Continually communicated to Senior and Executive Leadership teams on programs' status updates, KPI’s, milestone tracking, risk/mitigation strategies, budgetary updates, utilizing Microsoft tools that resulted in supporting the success of all vaccine programs.• Built supply chain and cost of goods models for all new vaccine modalities and provided data to senior management which resulted in obtaining over $60MM in capital funding for future site capacity expansion in the existing facilities.

New York, New York, Us

Project Leader that successfully led the implementation of several continuous improvement projects that provided significant yield increases, improved purity profiles as well as reduced cycle times and variations, and was a key influential liaison between Manufacturing Science and Technology, Production, Engineering, Regulatory, and Quality to ensure successful delivery of each project.• Successfully completed a Six Sigma Green Belt project by leading a cross-functional team to reduce variation by 10% in a protein purification process which equated to a net annualized savings realized $3MM.• Successfully led a project team and implemented an at-line in-process UV absorbance analysis which allowed for faster protein concentration analysis resulting in a 25% cycle time reduction in the purification process.• Interim manager for six months in which I supervised a team of Manufacturing Quality Engineers and Technical Writers to support vaccines manufacturing. • Successfully led a multi-disciplinary team to develop and implement a second-generation process for one of our protein processes that provided a 2X improvement in yield along with a higher purity.

Chuo-Ku, Tokyo, Jp

Provided QC Supervision for Amino Acid Quality Testing. Also provide QA support, customer service technical support, Analytical testing support, Project Management of new Analytical(PAT) technology, Statistical analysis, LIMS support, SAP functionality, QC Microbiology testing, etc.

Responsible for all QC and QA areas.

Chuo-Ku, Tokyo, Jp

Bench chemist and microbiologist

Arlington, Virginia, Us

Full-Time Military service from 1989-1991. Worked as a Lance Missle operator and security. Served during Desert Storm.US Army National Guard from 1991-1996. Worked as a Forward Observer.

Matthews, North Carolina, Us

Trained in finance, TQM, store management.