Lee Crawford Email and Phone Number

Develop and manage the project management department including CDMO for radiopharmaceutical products.• Attended SNMMI 2024 Conference in Toronto. • Assessment of current practices including process mapping of procedures. • Reviewed all GMP SOPs• Development of performance indicators

Supporting clients in the regulated healthcare industry, particularly with quality systems, validation and qualification, documentation, and procedures development / implication.

Project management spanning multiple departments, divisions, and sites, while ensuring regulated health authority compliance including all Analytical Instrumentation Qualification (AIQ) and support (calibration, maintenance, procedures etc.), global deployment of enterprise chromatography systems, building renovation, equipment/lab relocation, streamline workflows and maximize efficiencies while reducing time and cost•Managed qualification and validation of laboratory equipment and instruments over multiple divisions, labs, and sites including GMP and GLP requirements, computerized systems, etc. resulting in rapid deployment and release of equipment for GMP use•Managed equipment moves for building renovation while maintaining qualified state of systems resulting in no impact to project timelines•Instrument lifecycle qualification model development and implementation. Integration / harmonization of processes, SME, and primary trainer for new qualification approach. Greatly improved efficiencies of the process and built strong qualification teams (Quality, Validation, lab personal, Vendors, etc,) •Drafted, reviewed, and approved multiple qualification/validation documents, SOPs, LPs, and worksheets. Developed quality approved master templates for efficient and timely deployment •Supervised, ensured the calibration and maintenance of laboratory instruments and equipment, built strong relationships and teamwork among customers and supported groups. •Risk assessments, investigations, impact assessments, deviation reports, audits, responses, and other activities related to health authority regulations resulting in outstanding record of compliance• Business Owner for Empower2, Empower2 global deployment project (over 500 systems/2000 components, multiple sites) resulting in project delivery ahead of schedule and under budget

Merged with Merck, see above

Project management/consulting at various major Pharma companies including review and evaluation of cGMP and GLP documentation, commission and validation of laboratory equipment, processing equipment, facilities, all phases of process development and qualification, familiarity with FDA and EU regulation. Managed region business including proposals, project accounting, staffing, and forecasting. •Sanofi Pasteur Cleaning Validation, Swiftwater, PA. Managed / performed / supported development of various platform cleaning validation programs for production of vaccines. Cleaning verification/validation studies of clinical manufacturing. Managed team in drafting protocols, execution, and reporting. Heavily involved in deviation investigation and resolution.•Wyeth Vaccines Polysaccharide Production Cleaning Validation, Pearl River, NY. Managed $2 million cleaning validation program, cleaning verification following clinical manufacturing, drafting protocols for cleaning verification/validation studies. Developed high level cleaning qualification and harmonization processes across sites.•Roche Molecular Systems Full Scale Bulk Facility Tanks, Branchburg, NJ. Performed gap assessment, shakedown, IOQ of tanks systems. Developed CIP cycle (HMI/SCADA) and cleaning validation protocol.•BMS Renovation, Building 92, New Brunswick, NJ. Drafted system commissioning protocols and inspection and test plans for the building systems and utilities.•Schering-Plough Renovation, U-13, Union, NJ. Drafted System Commissioning Protocols for stability chambers•Wyeth Vaccine Development Facility LSV Project, Research Triangle Park, NC. Managed laboratory and process equipment qualification team following building renovation•Johnson & Johnson LSV / PSV Project, Beerse, Belgium and Raritan, NJ. Qualification of laboratory instrument and process equipment. Developed the departmental LSV methodology. Drafted SOPs for equipment use, maintenance, and change control procedures

•Developed analytical methods, selected, and optimized formulation and manufacturing process for poorly soluble drug. Developed, manufactured, and evaluated self-emulsifying liquid-filled capsule of poorly soluble drug molecule. Developed, manufactured, and evaluated Milled Solid Dispersion (MSD) tablets oral drug delivery systems of poorly soluble drug molecule using extrusion technology. Participated on a team that developed instrumentation validation policy for the department. •Developed formulations and analytical methods for viral vector and topical products. Established a biologics hazard lab for working with viruses. Prepared SOPs and trained colleagues in biohazards and rDNA handling procedures. Developed topical drug delivery systems for poorly soluble drug molecule. Developed analytical methods to resolve and quantify antibacterial components. Participated on team in the selection of new Laboratory Information Management System (LIMS).•Developed analytical methods anti-AIDS and anti-cancer drug molecule. Developed and validated HPLC assay methods. Performed stability testing for clinical batches. •Supervised physical testing for IND and NDA parenteral and oral drug products. Led analytical team in the design and validation of the new USP water system. Developed analytical methods and performed stability testing for over-encapsulated marketed drug product in blinded clinical comparison study. Formed team that oversaw all aspects of department 100+ PCs. •Performed preformulation studies on drug candidates. Facilitated setting up a new developmental group for IND submission work. Set up new laboratory equipment, established procedures, and trained new staff for the group. Developed protein sequence and analysis methods, and performed preformulation studies on protein drug. Performed preformulation, excipient compatibility, and solubility enhancement techniques with Cyclodextrin and PEG IV.

Merged with Pfizer, see above

Organic synthesis, process improvement, and scale-up of small molecule drug candidates and intermediates