Frank T. Email and Phone Number

Sole proprietor of a Medical Device/Pharma (biologics) consulting firm with 40+ years of experience specializing in the following areas : * R&D and MOB project management * Quality Systems Management Systems (QMS); development, implementation, and operation * Systems gap analysis * Analytical labs GLP assessment * Assistance with analytical method development, validations, and method transfers. * Establish RM, product… Show more Sole proprietor of a Medical Device/Pharma (biologics) consulting firm with 40+ years of experience specializing in the following areas : * R&D and MOB project management * Quality Systems Management Systems (QMS); development, implementation, and operation * Systems gap analysis * Analytical labs GLP assessment * Assistance with analytical method development, validations, and method transfers. * Establish RM, product release, API, and stability specifications. * Pre and post site audit preparation and remediation * CM(R)O and vendor audits *Assist with global product registrations * Batch record and product release reviews Show less

Managed all aspects of projects from inception to launch, including budgets, team selection, CDMO selection, milestones, and timelines. Project portfolios included medical devices, combo products, Rx, OTC, sterile products (injectables and non-preserved), and nutraceuticals. Launched over 5 new products in 6 years.

Note: BHC split from Bausch & Lomb and I stayed with Bausch and Lomb.Managed all aspects of projects from inception to launch, including budgets, team selection, CDMO selection, milestones, and timelines. Project portfolios included medical devices, combo products, Rx, OTC, sterile products (injectables and non-preserved), and nutraceuticals. Launched over 5 new products in 6 years.

Maintained the wet chem, GC, HPLC, Micro and dissolution laboratories in a state of compliance while meeting lab metrics of first time right, product releases and stability quotas (to include epi-pen) and laboratory investigations. Deliver 10% cost efficiency improvements annually. Ensured that all requisite training is scheduled and completed on time.Managed over 40 people with 4 direct reports on multiple shifts.Facilitated team to revise 6 SOPs and provide training to over… Show more Maintained the wet chem, GC, HPLC, Micro and dissolution laboratories in a state of compliance while meeting lab metrics of first time right, product releases and stability quotas (to include epi-pen) and laboratory investigations. Deliver 10% cost efficiency improvements annually. Ensured that all requisite training is scheduled and completed on time.Managed over 40 people with 4 direct reports on multiple shifts.Facilitated team to revise 6 SOPs and provide training to over 200 people in 2 weeks to correct audit finding.Increased Lab Invalid approval times by over 50% resulting in an approximate 25% increase in product releases Show less

Provided analytical support for product transfers, method improvements, method development and validations, compendia update reviews and mitigation, manufacturing issues, regulatory filings and QC for small molecule and sterile biologics. Responsible for implementing and maintaining the site wide stability programs for new and existing products. Additional responsibilities included development of new business plans, project management and customer interface for new and existing… Show more Provided analytical support for product transfers, method improvements, method development and validations, compendia update reviews and mitigation, manufacturing issues, regulatory filings and QC for small molecule and sterile biologics. Responsible for implementing and maintaining the site wide stability programs for new and existing products. Additional responsibilities included development of new business plans, project management and customer interface for new and existing products.Served as analytical and stability interfaces for as it relates to the development and implementation of strategic and tactical drug product formulation and process development /optimization plans. Accountable for the development and commercialization of new NDA, ANDA, and OTC products through all stages of drug development. Provided analytical support for a lean manufacturing imitative for new and legacy products to ensure processes are capable, reliable, and efficient. Delivered $150K savings annually.Managed the development and commercial stability programs for the Rochester site; 50+ ongoing stabilities. The CM(R)O portion of the stability program generated over $400K in revenue annually.Project manager for top 3 site strategic projects which are projected to deliver $5M+ in revenue annually. Show less

Provided analytical support for product transfers, method improvements, method development and validation, compendia update reviews and mitigation, manufacturing issues, regulatory filings and QC. Established and maintained a QC biologics testing laboratory for a sterile injectable biologic. Managed analytical methods development, validation, troubleshooting, in support of phase II, III and IV new drug development (both small molecule and biologics) resulting in new product sales of… Show more Provided analytical support for product transfers, method improvements, method development and validation, compendia update reviews and mitigation, manufacturing issues, regulatory filings and QC. Established and maintained a QC biologics testing laboratory for a sterile injectable biologic. Managed analytical methods development, validation, troubleshooting, in support of phase II, III and IV new drug development (both small molecule and biologics) resulting in new product sales of more than $1B.Identified and implemented laboratory efficiencies and improvements for new and legacy products, to improve OEE, eliminate waste, and reduce COGs resulting in savings of ~$350k annually.Through the implementation of lab efficiencies reduced lab staff by 350% while sample load increased by over 200%.Developed and implemented a novel way of performing material Id’s real time and at times without opening the container using a hand held Raman device. Estimated initial annual saving of $275k in material and time.Established in-process and finished product tests and specifications, performed all method validations and prepared all requisite analytical reports and documentation, worked with RA in preparation of the CMC section and provided responses to agency questions regarding the BLA filing of a sterile injectable filing. Approval was given in 10 months.Developed and managed departmental and project operational and capital expense budgets exceeding $1.5M.Maintained laboratories in a state of compliance to both FDA and international regulations: No major audit observations.Built product inventory to support 24 hour market launch. Show less

Managed the corporate document control, complaints, corporate CAPA system and corporate Quality Supplier Program. Maintained Global QA systems, compiled and reported periodic global quality metrics to senior management (to include CEO and CFO), and conducted Quality Management Reviews. Participate in and prepared for domestic for global audits. Prepared and conduct global recalls and maintained the system for MDR’s.Directly responsible for the creation and implementation of a Quality… Show more Managed the corporate document control, complaints, corporate CAPA system and corporate Quality Supplier Program. Maintained Global QA systems, compiled and reported periodic global quality metrics to senior management (to include CEO and CFO), and conducted Quality Management Reviews. Participate in and prepared for domestic for global audits. Prepared and conduct global recalls and maintained the system for MDR’s.Directly responsible for the creation and implementation of a Quality System for invasive, non-invasive and active medical devices to support domestic and international markets.Prepared 21 Global Quality Directives (SOP’s) in response to FDA audit findings. They were implemented before FDA audit was completed to correct 21 major findings. Auditor accepted all 21 SOPS which resulted in a NAI audit result.Applied Kanban principle to organize warehouse product flows, resulting in a 43% efficiency increase in 6 months which resulted in quicker inventory turnaround times and reduction in warehouse staff. Show less

Global and Domestic support of both existing products and lens material development.

Responsible for global analytical support of all contact lens manufacturing facilities and contact lens research. Duties included general troubleshooting, polymeric and small molecule material characterization, product release testing, purification, specification setting, methods development, method validation and transfers on a global level, toxicology testing and analytical documentation to support regulatory filings. The laboratories included surface science (XPS, AFM, SIMS, MS/MS with GC… Show more Responsible for global analytical support of all contact lens manufacturing facilities and contact lens research. Duties included general troubleshooting, polymeric and small molecule material characterization, product release testing, purification, specification setting, methods development, method validation and transfers on a global level, toxicology testing and analytical documentation to support regulatory filings. The laboratories included surface science (XPS, AFM, SIMS, MS/MS with GC and LC interface, MALDI/TOFS), spectroscopy (NMR and IR), materials characterization, oxygen permeability, separation science and wet chemistry. Responsible for 6 direct reports and over 25 international indirect reports. Developed and maintained the analytical budgets. • Analytical representative for R&D projects that resulted in 3 novel contact lens products obtaining market approval which resulted in over $600M in sales annually. Show less

Eastman Kodak 1977-1988As a research chemist performed analytical methods development, protein/natural product purification and recombinant research with a patent application. Supervised bio-separations laboratory in support of corporate and bio-products research.