Director
CurrentProject Manager with over fifteen (15) years of experience in the design, project management and construction for facilities, process, and utility capital projects for the Biotech Industry. Routinely managed complex projects with responsibility for multidisciplinary detailed design packages, competitive bidding, construction management of contractors and trades, within active manufacturing facilities while administering cGMP’s through project lifecycle. Extensive experience with HVAC Systems and control philosophy for Clean Rooms requiring design, construction and validation for ISO classified environments. Typically manages strategic capital projects, incorporating bioprocess equipment and infrastructure upgrades to support biologics manufacturing, chemical intermediate manufacturing, clinical and pilot plant manufacturing. Possesses extensive design and project management experience in executing multiple concurrent projects with ISO controlled environments, HVAC and utility infrastructure (including biologics cell culture and purification upgrades; cryogenic storage capacity projects; laboratory and building infrastructure renovations), and commissioning and qualification (C&Q) to support manufacturing. Project execution focused on safety, schedule, and budget adherence in addition to complying with good engineering practices, company policies and standards, regulations, and code requirements. Regulatory experience includes supporting projects from initial discovery through technology transfer to support NDA/BLA filings, coupled with practical experience managing FDA and international regulatory Pre Approval Inspections, Annual Inspections, and Audits.