Crystal Tina Pinto

- Summarizing, reviewing and interpreting Protocols from pharmaceuticals, biologics - Preparing and completing on-time submissions to Research Ethics Board and to regulatory agencies - Reviewing Health Canada NOL letters, PI Approval and Modification letters - Submitting Protocol Deviations, Annual Reviews, Study Closure requests to regulatory agencies - Resolving any submission challenges - Write, review and submit informed consent forms, protocol amendments, SAEs, annual review reports - Communicating with trial sites regarding regulatory requirements - work on continuous improvement initiatives

• Review QC Microbiology records according to internal QAM-210 Data Review SOP • Ensure laboarotory raw data records reviewed are compliant to methods, specifications and company’s applicable SOPs • Review microbiology testing, Validation/Method Transfer/Verification reports and ensure they are compliant as per protocol and method provided by clients/SGS , USP, EP, JP, BP • Assist in closure of OOS and deviations, submit records to QA for release of Certificate of Analysis and that Report of Analysis is released where necessary • Review data in a timely manner and approve of records prior to due date, audit logbooks • Working knowledge of Microsoft Office Suite and LIMS software

• Qualification of GMP facility, method validations, growth promotion testing, gowning qualifications, sterility, endotoxin, bioburden, mycoplasma, growth promotion testing, gram staining • Environmental monitoring of controlled GMP manufacturing areas, during fills and laboratory areas • Sampling and analysis of purified water system for bioburden, endotoxin, TOC and conductivity • Calibration of laboratory equipment which includes IQ/OQ/PQ • Author and review SOP’s, test procedures, method/equipment validation protocols, reports, and log books, perform data trending • Initiate and assist in closure of laboratory investigations, change controls, non-conformances, CAPAs • Partner with cross departments to ensure microbial product testing is completed and coordinate release of test results in a timely manner

• Perform quality control Microbiology testing of raw material and finished drug products according to standard operating procedures (SOPs) • Maintain laboratory records and responsible for routine monthly environmental monitoring of production facility. • Perform calibration/maintenance of equipment and inventory of incoming raw materials • Follow cGMPs, SOPs, USP, and FDA guidelines in all appropriate functions • Plan, implement, and successfully complete assigned tasks in a timely fashion • Conduct investigations for testing failure and non-conformances. • Author, revise, and review technical documents, including SOPs • Adhere to GMP regulations by maintaining complete records pertaining to all aspects of microbiological testing, routine operations, and assist in training of other colleagues.

Project title: Testing the anti-microbial activity of Abeego products and its constituent parts (In collaboration with Abeego Inc., Victoria, Canada) • Testing the antimicrobial activity of Abeego products against common food-borne pathogens and environmental contaminants, bacteriophages and yeast • Experience handling various level-2 laboratory pathogens, enumerating bacteria, phages and yeast, conducting plaque assays • Knowledge of using programs like GraphPad Prism to analyze experimental data.

Publication: Stable, temperature-sensitive recombinant strain of Mycobacterium smegmatis generated through the substitution of a psychrophilic ligA gene Crystal T Pinto and Francis E Nano FEMS Microbiology Letters 09/2015 Laboratory skills: • Expertise in Microbiology and molecular cloning techniques (including cloning in M.tuberculosis and M. smegmatis) • Robot handling and microtiter plate based assays • PCR techniques like EP-PCR and StEP PCR • Electrocompetent cell preparation, cell culture, cell isolation, DNA Assembly methods • Autoclaving media and glassware • Working with sensitive laboratory equipment • Organizing and prioritizing day- to-day activities

• Assisting students in molecular cloning and animal tissue culture experiments • Marking student lab reports • Assisting the instructors in setting up the laboratory and laboratory clean-up

• Assisting the instructors in setting up the laboratory • Assisting students in lab experiments • Helping with lab clean up at the end of the session • Marking the laboratory coursework

• Investigate and settle critical illness, accident and death claim cases efficiently and accurately • Highest claim settlement ratio of 96% for the FY 2011-2012 • Interact with claimants to understand the nature of the claim and make decisions • Experience with data entry, copying, scanning, faxing, filling and track invoicing • Document and summarize file activity • Provided support to colleagues in handling claim cases

- Masters in Biotechnology from University of Mumbai - Project at Indian Institute of Science. Department of Biochemistry Project title: Studying the role of different thymocyte cell surface markers during S.typhimurium infection" and differences in proteomic profiles of S. typhimurium WT and dpepN Laboratory skills: • Expertise in microbiology techniques like streaking and spread plating of micro-organisms • Growth curve experiments to timely monitor the growth of micro-organisms and plate them at required time-points • Preparing the samples for fluorescent activated cell sorting (FACS) • Running 2D- Gel Electrophoresis • Extracting cytosolic and secretory proteins • Protein estimation and enzymatic activity determination

Quality control of milk and milk products

Thesis title: Temperature sensitive Mycobacterium tuberculosis as a potential vaccine candidate