Nicholas Venema Email & Phone Number

Toronto, On, Ca

• Support client’s customized LabWare LIMS system as the System Site Lead for all areas of the business that utilize the LIMS system • Debug Oracle SQL and LIMS basic code to isolate errors that occur from generating a reports, advanced calculations, generation of charts and custom features the client has added to their LIMS system• Efficiently create advanced SQL queries to isolate data, hidden fields and to find solutions to errors and new requests, such as custom data explorers that execute code more efficiently core feature to fulfil the client’s needs• Tactically manage meetings with the business and the LIMS team to obtain an outcome that the business needs and meets the regulatory requirements for the code and system compliant requirements of the client• Skillfully manage support tickets using the client's platform of Service Now, triaging tickets in order of priority and follow up on longer-term tickets to ensure the customer gets the desired compliant result swiftly as possible • Manage the client support team and create processes for their team to utilize the IDM platform to update, create, cancel LabWare LIMS customer accounts

• Support client’s customized LabWare LIMS system as the System Site Lead for all areas of the business that utilize the LIMS system • Debug Oracle SQL and LIMS basic code to isolate errors that occur from generating a reports, advanced calculations, generation of charts and custom features the client has added to their LIMS system• Efficiently create advanced SQL queries to isolate data, hidden fields and to find solutions to errors and new requests, such as custom data explorers that execute code more efficiently core feature to fulfil the client’s needs• Tactically manage meetings with the business and the LIMS team to obtain an outcome that the business needs and meets the regulatory requirements for the code and system compliant requirements of the client• Skillfully manage support tickets using the client's platform of Service Now, triaging tickets in order of priority and follow up on longer-term tickets to ensure the customer gets the desired compliant result swiftly as possible • Manage the client support team and create processes for their team to utilize the IDM platform to update, create, cancel LabWare LIMS customer accounts

• Support client’s customized LabWare LIMS system as the System Site Lead for all areas of the business that utilizes the LIMS system • Debug Oracle SQL and LIMS basic code to isolate errors that occur from generating reports, advanced calculations, generation of charts and custom features the client has added to their LIMS system• Efficiently create advanced SQL queries to isolate data, hidden fields and to find solutions to errors and new requests, such as custom data explorers that execute code more efficiently core feature to fulfill the client’s needs• Tactically manage meetings with the business and the LIMS team to obtain an outcome that the business needs and meets the regulatory requirements for the code and system compliant requirements of the client• Skillfully manage support tickets using the client's platform of Service Now, triaging tickets in order of priority and follow up on longer-term tickets to ensure the customer gets the desired compliant result swiftly as possible

Guelph

• Design, configure, and review LIMS analyses containing format calculations and subroutines with complex calculations for impurities, dissolution, and content uniformity• Configure stability protocol templates, formulation templates, test articles, as well as set up and approve and modify Stability Protocols as an end user to meet the requirements for the site’s Stability Program • Review of configured LIMS master data objects including products, stored queries, analyses, batch test templates, item codes, test methods, formulas and associated objects ensuring proper configuration and that requirements are met• Create configuration packages for migrating products and ensure all associated objects are included to ensure that functionality for end users is retained between LIMS environments. Perform the export and import of configuration packages• Ensure compatibility of configured LIMS objects with the Empower Interface and aided the site with implementing the interface • Train end users on LIMS and LIMS Interfaces for SAP and Empower, prepare instructions documents and provide addition training sessions on advanced functions in LIMS• Design and present metrics to track progress of the configuration of finished products, raw materials, and packaging components • Update SOPs to align with the implementation of LIMS system at the Guelph site

Mississauga, Ontario, Canada

• Managed Crop protection submissions using document management software (e-index) and reviewed submission packages for completeness and accuracy and regulatory compliance• Drafted History of Use submissions (DACO Value 10) and Product comparison tables (DACO 10.2.4)• Researched regulatory requirements and determined submission category types by accessing the PMRA website to reference the current Use Site Category DACO tables• Prepared technical documents (summaries/waivers) for Canadian submissions• Ensured the maintenance, quality and analysis of field biology data for regulatory submissions• Assisted BASF Regulatory Product Managers with maintenance and support of current product registrations by providing appropriate technical information• Designed and updated product labeling to for new products and additions to current products• Reviewed and prepared data packages for submission to the PMRA, HC, CFIA & other authorities

Toronto, On

• Accomplished with the use of Labware LIMS (v. 5) for the entry and calculation of sample data (including the use of the Empower interface for automatic transfer of results) as well as reviewing data entries; ensuring test was performed correctly for batch release• Proficient at running and troubleshooting complex Assay and RC testing on liquid and solid drug products using HPLC (Agilent 1100, 1200s and Waters systems) with empower software (2A)• Expert at running Automated and Manual Dissolution testing coupled with GLP Chemstation (v. 6) with UV spectrometer/HPLC analysis systems• Experienced at testing for Identity of compounds using techniques such as FTIR, TLC and Wet Chemistry• Effectively managed time to multi-task to complete several projects at once to meet the deadlines of the lab for both stability and new product testing; as well as supporting my team with their projects to work more efficiently to complete testing in the most timely manner

Toronto, On

• Liaised with the Apotex group of companies, providing documentation for submissions, deficiencies and annual reviews. Generated document summaries and technology transfers for document requests• Prioritized documentation prior to preparing in compliance with the Change Control Form (CCF) and established process using DDMS Trackwise and DocData Trackwise• Actively tracked documentation throughout the approval process to meet specified deadlines; using Content 7.0 and Trackwise • Ensured all method transfer documents and certificate of technology transfer are generated according to the test method, validation report, GMP, SOP and WI

Ottawa, On

• Effectively performed DNA amplification using PCR equipment• Effective at Engineering Recombinant plasmids using restriction enzymes and ligases• Proficient at inserting recombinant plasmids into bacteria using an BIO RAD Gene Pulser apparatus• Extracted and Purified antibodies using an AKTA FPLC efficiently• Multi-tasked to complete experiments in a timely manner

Guelph, On

• Analyzed collected data and wrote comprehensive laboratory reports proficiently• Skilled in various forms of chromatography using liquid/liquid extractions and SPE columns• Operated an Agilent 1100 HPLC system to analyze extracted samples to evaluate the amount of pesticide remaining on the crops

Advanced Configuration Using Lims Basic Certificate

Course covers the LIMS Basic macro scripting language that can be used for defining calculations, event triggers, and automation scripts.

Regulatory Affairs Certificate, Regulatory Affairs

Bachelor Of Science In Technology, Applied Pharmaceutical Chemistry Co-Op

Diploma