Marc Balan Email & Phone Number

Toronto, Ontario, Canada

Senior CQV Support Consultant:Developed technical and manufacturing documentation for development studies, equipment qualification, and process validations of Single-Use Bioreactors, ensuring compliance with regulatory requirements, corporate standards, and site-specific validation guidelines.Supported the execution of development studies and protocols, ensuring accurate and timely completion to facilitate validation of bioreactor systems.Commissioning Consultant:Coordinated Commissioning/Qualification activities associated with the capital project portfolio.Ensured that all projects were delivered to meet customer expectations and meet the highest safety, environmental, quality, operational, and performance standards.Managed project milestones and communication plans, ensuring stakeholder engagement and adherence to quality and regulatory guidelines.Prepared, reviewed, and approved Validation Plans (VP), User Requirement Specifications (URS), Functional Specifications (FS), and qualification protocols.Executed qualification protocols for HVAC, BAS, and downflow hoods in GMP environments.Investigated and approved discrepancy reports. Ensured Part 11 Risk Assessments are completed when applicable.Validation Consultant:Executed the qualification protocols for temperature controlled equipment including walk-in refrigerators, incubators, and freezers in QC laboratories.Performed thermal validation using data loggers and Kaye Validator.Consolidated and reviewed all raw data and prepared the Qualification Summary Reports.Scheduled qualification activities to ensure the availability of the equipment and minimize disruption while adhering to deadlines.Coordinated with the Validation and Quality Assurance departments to ensure prompt review and approval of the protocols and reports.

Toronto, Ontario, Canada

Executed Commissioning and Qualification protocols and test scripts of systems associated with downstream process equipment, adhering to the defined schedule.Review technical and quality related documentation, ensuring that all operating procedures, training plans, and manufacturing documentation are current, and developed to conform to global and site policies.

Toronto, Canada Area

Lead team of 8 people as Subject Matter Expert (SME) in component pertussis (cP) vaccine manufacturing facility.Appointed area trainer for the Cadence Project to increase product output.Present process abstract to regulatory affairs from Health Canada and FDA inspections.Achieve performance metrics for Batch Production Record review.Lead the hazard and operability study (HAZOP) to identify potential hazards in the area.Work with manufacturing technology (MTech) group to improve yield and productivity.In-process and utility sampling for bio-burden, endotoxin, environmental monitoring.Assist cleaning validation of buffer tanks and chromatography columns.Coordinating, investigating and assessing Change Control Requests.

Toronto, Canada Area

Routine Chemical testing of intermediate and final products for Aluminum Determination and SDS-PAGE.Prioritize weekly testing and project schedule ensuring deadlines are met. Performing tests efficiently while ensuring accurate/reliable results.Maintenance of Quality Systems (including adherence to GxP documents related to facilities, equipment and testing). Valuable resource for document workflows throughout QC Chemistry.Trusted by management to initiate process updates through detailed change controls, CAPAs, and protocols while communicating with members from Validation, Quality, and Regulatory Affairs.Proven problem solving skills to identify root cause in out-of-specification results and lab investigations.

Toronto, Canada Area

Integrating biochemical and biophysical techniques to determine a high-resolution structure of a protein-protein complex.Performing daily tasks and analyzing results from analytical techniques including anion exchange chromatography, mass spectrometry, NMR spectroscopy, UV and fluorescence photospectrometry.

Waterloo, Ontario

Maintained a safe laboratory environment ensuring proper techniques and procedures were followed.Provided guidance to students questions pertaining to the lab experiments and report.Marked lab reports in a timely manner and proctored the final exam.

Determined the method of inhibition of an inhibitor of the gluconeogenic pathway.Responsible for the expression, cell lysis, and purification of the enzyme in addition to kinetic characterization and statistical analysis with the inhibitor.

Winnipeg, Canada Area

Utilized bioinformatics software for DNA alignment and analysis of gene sequencesIsolated, amplified, cloned and expressed genes using a bacterial plasmid vectorExperience with tissue culture, protein purification, PCR, gel electrophoresis, and Western blot analysis

Winnipeg, Canada Area

Responsible for receiving and storing specimensExecuted an assay for confirmation of Treponema pallidum antibodies in human sera paying special attention to detail and precisionEntered results and observations into the database

Winnipeg, Canada Area

Carried out research projects on two vaccine preventable bacteria (Haemophilus influenza and Bordetella pertussis)Completed antibiotic susceptibility testingLearned how to identify these bacteria by performing biochemical testsPerformed PCR, gel electrophoresis and DNA purification

Msc, Molecular And Structural Biology

Bachelor Of Science - Bs, Biochemistry