Tim Lee, Ph.D. Email & Phone Number

Canada

Toronto, Canada Area

- Regulatory approval of Class III Sterile Medical Devices Pre-Market Applications (PMA)- Defend Quality Management System for Health Canada, EU, Brazil, USA, Australia Audits- Instrumental in MDSAP Audit

Toronto, Ontario

-Managing research and development of dermal filler, Platelet Rich Plasma and osteoarthritis medical devices globally- Prepare and review clinical study design, progress and final reports for internal and external studies- Monitor patent and scientific literature and review competitor technology developments- Administer research budgets (plan budgets, authorize purchases) and lab operations- Provide technical responses to Regulatory Bodies in preparation of PMA application- Instrumental in the FDA Approval of Revanesse Versa product (HA dermal filler) in the US- Prepared the Design Dossier for Canadian, US and European approval of all products- Involved in GMP audits from FDA, Emergo, BSI

Mississauga Campus

-Masters in Biotechnology and Corporations (MBioTech Program)- Biopharmaceutical Manufacturing- cGMP compliance, sterility assurance, ICH guidelines on pharmaceutical development, risk management and Quality systems- Mergers and Acquisitions, IPO basics and VC

New Jersey/ Toronto

- Bio-Pharmaceutical Manufacturing- GxP compliance and ICH guidelines- Risk Management- Quality by Design- Biosimilarity and Comparability- Good Documentation- Audits, Inspections and Root Cause Analysis

Irvine California

- Leading upstream and downstream in the manufacturing of biologics and small molecules expressed in bacteria and mammalian cells- Late phase clinical manufacturing (Phase II/III) and IND submission- Managed a BSL3 facility for the development and production of Clostridium Botulinum- Member of the "Integrated Preclinical/Clinical AIDS Vaccine Development" Special Emphasis Panel at the Department of Health and Human Servies (November, 2014, Rockville , MD)Lee, Timothy, 2014. Speaker and Session chair at Bioprocessing Summit, Boston MA (December)

Greater Boston Area

Providing business proposals outlining development and manufacturing strategies for new opportunities within biopharma using scientific and technical know-hows to meet the customer's needsExpertise:Process Development & ManufacturingQuality Assurance and Quality ControlBiodefense/Pandemic ResponseDrug Delivery DevicesLee, Timothy. 2016. Parenterals and Injectables. Organizing Committee member, Istanbul, TurkeyLee, Timothy. 2015. Parenterals and Injectables. Organizing Committee member, Chicago.Lee, Timothy. 2013. Technical approaches to enhance biodefense and pandemic responses. Pre-Filled Syringe Summit, Washington DCLee, Timothy. 2013. Workshop on Process considerations for the manufacture of vaccines form upstream to pre-filled stages. Pre-Filled Syringe Summit, Washington DCLee, Timothy. 2013. Challenges and exciting solutions to bioprocessing operations for the manufacturing of therapeutic protein candidates. BioProcess International. Cambridge, Massachusetts.Lee, Timothy. 2013. Using small-scale studies to optimize process operational parameters for scaling to commercial scale in a cost and time efficient manner. Bioprocessing summit. Cambridge, Massachusetts.Lee, Timothy. 2013. Challenges and exciting solutions to downstream bioprocessing operations for the manufacturing of therapeutic vaccine candidates. Vaccine and Vaccination. Las Vegas, Nevada.

- Managed approximately 40 operators and managers to improve safety, quality and supply of products- Efficiency enhancements through design of daily management systems resulting in non-conformation reduction, increase safety and improved scheduling and production efficiencies

ORAL PRESENTATIONS Lee, Timothy. 2012. Challenges and Solutions to Downstream Bioprocessing Operations. World Congress Vaccine, Washington D.C.Lee, Timothy. 2011. Revolutionizing upstream and downstream process development. Bioprocessing Summit. Frankfurt, Germany.Lee. Timothy. 2010. Challenges and solutions to downstream bioprocessing operations for the manufacturing of vaccine candidates. Cambridge Healthtech’s Immunotherapeutics and Vaccine summit. Cambridge MassachusettsLee, Timothy. 2009. Development of a systematic approach to the downstream recovery of protein vaccine products. Vaccines Europe Conference 2009. Brussels, Belgium.Lee, Timothy. 2008. Trouble-shooting fermentation and Primary recovery manufacturing issues in order to optimize antigen expression used as vaccine candidates against infectious diseases. Vaccine Technology II. Albufeira, Portugal.Lee, Timothy. 2006. The scaling up of the clarification process for the recovery of recombinant protein antigens used as vaccines against infectious diseases. Industrial and Engineering Chemistry Division, American Chemical Society. San Francisco, California.Lee, Timothy. 2005. The scaling up of fermentation and clarification processes of protein antigens suitable as vaccine candidates against infectious diseases. Biochemical Technology Division, American Chemical Society. San Diego, CaliforniaLee, Timothy. 2005. The scaling up of fermentation and clarification processes of protein antigens suitable as vaccine candidates against infectious diseases. Invited speaker at Cambridge Health Institute at MIT, Boston Lee, Timothy. 2004. The scaling up of the fermentation and clarification processes of recombinant protein antigens used as vaccines against infectious diseases. Biochemical Technology Devision, American Chemical Society. Anaheim, California.

Toronto

Generated $21M in annual operational cost savings through design and implementation ofprocess metric initiatives emphasizing continuous improvement* Executed cross-training plan for manufacturing staff members to improve operationalcompetency within department* Explored and designed ``Kaizen`` initiatives to control inventory of raw materials through 5S* Established GMP compliance in personnel and equipment work flow through procurement ofupper management support through $1M capital investment* Equipped 15-member production service department with proper work standards resulting in100% completion of work orders with 0 % defect rate (Annual cost savings of $1.1M)* Facilitated and coordinated communications between departments to support the validationof manufacturing facility

Led multi-disciplinary staff and international process transfer from bench to 1000 Litremanufacturing scale* Generated 50% productivity increase and $2.3M annual operational cost savings* Managed cross-functional teams (manufacturing, Mtech, RA, QA, QC, purchasing, finance) andaccelerated project delivery to produce Phase II/III material in aggressive 2 month timeline* Transferred and improved vaccine productivity yield by 3 million doses upon scaling up to 1000Litres for contract manufacturing organization* Provided new drug development reports and IND documentation to RA which include processand assay development, product characterization and process validation

Designed and validated robust recovery processes by QbD resulting in increase in productivity(1 million doses), safety (10-fold reduction in LAL concentrations) and cost savings (eliminationof additional column purification step)

Constructed platform methodology for the recovery of soluble, inclusion body, membrane andextracellular proteins leading to reduction of process development time by 6 months tomanufacturing

Cloning Hepatitis B constructs and studying their effect in therapeutic experiments

Phd, Biochemical Engineering

Activities and Societies: Teaching Assistant in industrial bio-processing within the pilot plant at University of London

Education record

Activities and Societies: Critical Thinking & Innovation, Business Management Strategies, Management Communications Skills, Taking Control.

Msc, Applied Molecular Biology & Biotechnology

Bsc. (Honours), Molecular Biology & Genetics