Katarina Aleksa
Ancaster,ON
Summary
Scientific leader with expertise in biology, toxicology, and pharmacology, specializing in GLP-compliant research and method development. Proven ability to lead cross-functional teams in regulated environments, ensuring alignment of R&D strategies with organizational objectives. Demonstrated success in driving innovation and quality improvement in laboratory and clinical settings. Extensive experience in consulting, research, and education to advance the development of novel health-related compounds.
Overview
18
18
years of professional experience
1
1
Certification
Work History
Senior Director Toxicology
Labstat International
Kitchener, Canada
06.2024 - Current
- Led a multidisciplinary team managing the full in vitro toxicology workflow, ensuring scientific rigor and regulatory alignment, which resulted in a 15% increase in client satisfaction and on-time project delivery.
- Oversaw departmental financial performance, driving a 10% increase in profitability through strategic cost control, resource optimization, and targeted investments in capital equipment and R&D.
- Directed end-to-end project management, including study scoping, budgeting, and execution, ensuring timely delivery and adherence to client and regulatory requirements.
- Supervised study design/plan and execution, providing oversight for protocol development, SOPs, and production workflows to ensure consistency and compliance to GLP.
- Collaborated with the IT department to enhance the Laboratory Information Management System (LIMS) for GLP-compliant toxicology projects, focusing on improving data integrity, workflow efficiency, and user accessibility.
- Contributed to the design and implementation of system upgrades to better support regulatory documentation, sample tracking, and reporting requirements.
- Acted as the Test Facility Management representative for the Toxicology department, with responsibility for overseeing compliance with Good Laboratory Practice (GLP) standards.
- Ensured all facility non-conformances were promptly investigated and resolved, and that deviations were thoroughly documented, assessed for impact, and effectively managed to maintain regulatory integrity and operational excellence.
- Maintained client satisfaction through proactive communication and adherence to project timelines and quality standards.
- Participated ongoing quality audits to safeguard study integrity, reduce cost of poor quality, and implement continuous improvement initiatives aligned with GLP and industry best practices.
- Identified and resolved structural inefficiencies, realigning roles and workflows to improve departmental agility and operational efficiency.
- Developed and implemented performance metrics to monitor laboratory productivity and highlight areas for continuous improvement.
- Collaborated closely with Business Development to synchronize project timelines with client expectations and support long-term partnerships.
- Applied formal project management methodologies to streamline processes, manage risk, and ensure accountability across all stages of study execution.
Senior Director Commercial Product Development & Regulatory Affairs - Toxicology/Microbiology
Labstat International
Kitchener, Canada
06.2022 - 06.2024
- Developed a compelling business case and collaborated with assay vendors on licensing agreements and cost models for new offerings.
- Created R&D pipeline for the Toxicology department that aligns with client needs for regulatory and exploratory research.
- Served as Subject Matter Expert (SME) for Labstat’s Toxicology program, representing the company at major industry conferences including TSRC, CORESTA, and the Society of Toxicology (SOT) Annual Meeting.
- Delivered scientific presentations showcasing Labstat’s R&D in tobacco toxicology.
- Chaired multiple tobacco-focused sessions at TSRC and SOT, contributing to scientific discourse and industry collaboration.
- Currently serve on the TSRC Editorial Committee, supporting the development and review of scientific content for conference proceedings.
- Secured and led an FDA-funded project, developing new microbiological assays for tobacco and cannabis matrices, ensuring regulatory compliance and client satisfaction.
- Implemented an environmentally sustainable assay, reducing consumable usage by 20%.
- Directed a comprehensive laboratory process restructuring of the Toxicology department as Project Manager, to achieve full GLP compliance.
- Streamlined commercial product development projects, centralizing client requests and optimizing project prioritization.
- Oversaw construction of a cutting-edge $1M laboratory, enhancing assay capacity and operational efficiency.
- Developed a compelling business case and collaborated with assay vendors on licensing agreements and cost models for new offerings.
- Mentored team members, fostering their professional growth and development.
- Collaborated with cross-functional teams to secure licensing for innovative Toxicology assays and cultivate strong client partnerships.
- Led marketing initiatives to bolster Labstat's visibility and effectively promote new offerings via social media and direct client engagement.
General Manager Toxicology
Labstat International
Kitchener, Canada
01.2020 - 06.2022
- Directed operations for a team of 80+ staff, overseeing a multimillion-dollar budget and enhancing service quality, resulting in a 15% increase in efficiency.
- Served as GLP Test Facility Management representative for the Toxicology department, ensuring all studies maintained complete data traceability and full compliance with GLP documentation requirements.
- Reorganized the Toxicology department, enhancing service quality, internal customer focus, and cost savings.
- Led the establishment of a standalone microbiology laboratory, managing all phases from facility development to SOP/method validation, improving client satisfaction by 15%.
- Evaluate and monitor operational processes for the in vitro Toxicology assays (Ames, Neutral Red, Micronucleus and Mouse Lymphoma) as well as human plasma testing (Nicotine and Cannabinoids) to ensure they are performing within the established QC parameters.
- Oversaw the construction of a new Toxicology laboratory, expanding departmental capabilities and service offerings.
- Defined and implemented a new process manual, closing procedural gaps and ensuring full industry compliance.
- Introduced lean concepts, team huddles, KPIs, capacity planning, and scheduling optimization in a departmental overhaul project.
- Developed a new costing template, enhancing financial transparency and efficiency, allowing for the identification of 20% costing inefficiencies.
- Updated departmental organizational structure to improve operational effectiveness and align with strategic objectives.
Associate Clinical Laboratory Director
Seroclinix
Amherst, USA
01.2019 - 04.2020
- Contributed to the development and validation of clinical laboratory tests for a CLEP-certified laboratory, with a focus on clinical chemistry and drugs of abuse.
- Designed, implemented, and maintained comprehensive Quality Control (QC) and Quality Assurance (QA) programs to ensure regulatory compliance and high laboratory performance.
- Recruited, trained, and supervised laboratory staff, fostering a culture of accuracy, compliance, and continuous improvement.
- Developed strategic plans for method development and validation of pharmaceutical assays, ensuring alignment with GLP and regulatory standards.
- Acted as a key liaison between R&D and commercial teams to ensure seamless translation of laboratory-developed tests into market-ready solutions.
- Authored white papers supporting the commercialization of pharmaceutical testing using urine dried spot analysis.
- Collaborated with external vendors and partners to develop innovative laboratory tests utilizing dried spot sampling technology.
Toxicology Laboratory Director
Dent Neurological Institute
Amherst, USA
11.2018 - 04.2020
- Implement and maintain a QC/QA program for the testing of drugs of abuse in urine, ensure adherence to CLIA regulations.
- Ensure that all policies and procedures meet regulatory standards and are up to date.
Toxicologist
Risk Science International
02.2018 - 01.2020
- Conducted comprehensive risk assessments for various chemical compounds, ensuring compliance with regulatory standards and enhancing safety protocols.
- Developed a comprehensive drugs of abuse database for human pharmacokinetic and pharmacodynamic data from published literature, improving data accessibility and research efficiency.
- Compiled detailed legal risk assessments for legal proceedings, providing critical insights and supporting successful case outcomes.
- Created a pharmacokinetic-pharmacodynamic database for xenobiotics with a focus on pregnancy and lactation.
- Reviewed various legal cases and compiled exposure and toxicological assessment reports.
- Wrote manuscript on the pharmacokinetics and pharmacodynamics of opioids: pregnancy, delivery, lactation, growth and development which has been submitted to a peer review journal.
Laboratory Manager
McMaster University
Hamilton, Canada
02.2018 - 05.2019
- Oversaw all aspects of laboratory setup and operations, including procurement, staff training, and daily management to ensure efficient and compliant workflows.
- Designed the laboratory layout and equipment plan for Dr. Kidd’s research lab in the Department of Biology, optimizing space and functionality.
- Selected and managed vendor relationships, coordinated procurement, and installed all laboratory equipment and instrumentation.
- Authored the laboratory quality manual and standard operating procedures (SOPs), ensuring alignment with McMaster University’s safety and regulatory policies.
- Validated a total mercury assay using a Direct Mercury Analyzer (DMA-80) for the analysis of biological samples such as fish and invertebrates.
- Provided hands-on training to graduate and undergraduate students on the use of analytical instrumentation and general laboratory techniques.
Assistant Professor
University of Toronto
Toronto, Canada
04.2013 - 06.2017
- Designed and delivered a general science course and laboratory sessions to 40–50 pharmacy students as an invited lecturer, using an inquiry-based approach and real-world case studies to foster critical thinking and engagement.
- Developed and implemented hands-on laboratory exercises based on original thesis research, where students utilized HPLC instrumentation and statistical analysis to quantify xenobiotics levels in hair samples.
Clinical and R&D Research Associate, PhD candidate
Hospital for Sick Children
Toronto, Canada
11.2007 - 06.2017
- Developed a novel GC/MS/MS assay for a $2M multi-year research grant funded by CIHR and NIH, focused on the effects of brominated flame retardants (BFRs) on male fertility and prevention of nephrotoxicity in IFEX-treated patients.
- Led PBDE analysis for the CIHR project at the Toronto site, including developing the PBDE assay and SOPs, preparing the ethics submission and patient questionnaires, recruiting patients, processing samples, and authoring the publication manuscript.
- Designed and executed innovative research on the renal metabolism of the chemotherapeutic drug ifosfamide (IFEX), identifying that renal toxicity may be preventable with antioxidant therapy.
- Conducted in vitro and in vivo studies on the metabolism of IFEX and acyclovir by human and porcine renal cells; characterized CYP enzyme activity in porcine liver and kidneys.
- Initiated and led the procurement of $1.5M in capital equipment for a clinical research laboratory, preparing RFPs, evaluating vendor bids, and negotiating contracts that achieved 40% cost savings.
- Developed and validated new UPLC/MS/MS and GC/MS methods under ICH-GCP guidelines, reducing sample analysis turnaround time from 6 weeks to 1 week.
- Authored and maintained SOPs, validation protocols, and technical documentation; ensured data accuracy and scientific integrity in reports submitted to project investigators.
- Coordinated multiple research projects, managing timelines, budgets, and deliverables to ensure timely dissemination of results to academic collaborators.
- Collaborated with national and international research teams, including within the Hospital for Sick Children’s Research Institute, contributing to 42 peer-reviewed publications.
- Supervised and mentored over 20 MSc and PhD students, consistently praised for promoting independent thinking, professionalism, and a supportive learning environment.
- Developed and taught a general science course and laboratory sessions to pharmacy students as an invited lecturer; course was well received for its inquiry-based approach and use of real-world case studies to encourage critical thinking.
- Designed lab exercises based on thesis research, training students in HPLC and statistical analysis to measure caffeine levels in hair samples.
- Designed and managed a tissue culture facility, purchasing and maintaining all necessary equipment and training technical staff and students in cell culture techniques.
- Completed PhD research on the ontogeny of ifosfamide metabolism by the human kidney. Authored the clinical study protocol, secured ethics approval, and recruited and consented participants.
Education
Ph.D. - Pharmacology And Toxicology
University of Toronto
Toronto01-2004
Master of Science - Pharmacology And Toxicology
University of Ottawa
Ottawa01-2007
Bachelor of Science - Biology & Pharmacology
Mcmaster University
Hamilton, ON01-1993
Post-Degree Certificate - Human Health & Environment
Yale University, School of Public Health
New Haven, CT01-2020
Skills
- Regulatory Systems (GLP, CLIA, FDA)
- Strategic & Operational Planning
- Team leadership
- Operational excellence
- Quality assurance and risk management
- Project lifecycle & financial oversight
- Cross-sector collaboration
- Innovation and continuous improvement
- Performance management
- Public speaking & scientific communication
- in vitro Assays
- Clinical chemistry
- Scientific literature review
- Clinical and non-clinal in vitro and in vivo studies
- Collaborative leadership
- Practice operations management
- Pipeline development
- Organizational development
Accomplishments
Inaugural Croatian Women of Influence Award – Science and Technology Category Zagreb, Croatia • 2016
André Boivin Visiting Professorship Award for Maternal-Fetal Toxicology
Combined Award from Duchenay and the Motherisk Program at The Hospital for Sick Children • 2012
CIHR - CMAJ Top Achievement Award in Health Research • 2012
University of Toronto Fellowship • 2001 – 2003
Hospital for Sick Children Restracomp Grant • 2002-2003
Canadian Institute of Health Research (CIHR) Studentship • 1998-2001
Medical Research Council of Canada (MRC) Studentship • 1995-1997
Certification
GLP Study Director and Principal Investigator Training • Society of Quality Assurance • Issued 2022
New York State Department of Health, Certificate of Qualification for
Laboratory Director in Clinical Toxicology and TDM/TOX New York State Department of Health • Issued 2017
Languages
English
Professional
Croatian
Professional
Publications
- 44 publications in peer reviewed journals – list available upon request
Publications specific to nicotine and tobacco:
- Kosachevsky, P.; Aleksa, K.; Coffa, B.; Iorgulescu, D. 2025. Development of Enhanced Collection and Extraction Techniques for In Vitro Toxicology Testing of Next Generation Nicotine Products, Society of Toxicology, Orlando, March 2025
- Aleksa, Katarina and Coffa, Bonnie, 2025. Comparative Analysis of in vitro Testing for Oral Nicotine Products Versus Combustible Cigarettes: Implications for Public Health and Harm Reduction Strategies. Society of Toxicology, Orlando, March 2025
- Oh, Sean; Ma, Dong; Power, Landen; Aleksa, Katarina. 2025. Assessment of Nuclei-Based Cytotoxicity Measurement as an Alternative to Bead-Based Methods in Flow Cytometry. Society of Toxicology, Orlando, FL.
- Oh, Sean; Aleksa, Katarina; Ma, Dong; Power, Landen; Lie, Lauren; Coffa, Bonnie. 2024. Comparative Genotoxicity Assessment of Heated Tobacco Products (HTPs) and 1R6F Reference Cigarettes Using In Vitro Micronucleus Assay in TK6 and CHO Cell Lines, TSRC, Atlanta, GA and CORESTA, Edinburgh, 2024
- Oh, Sean; Moses, Sara; Aleksa, Katarina; Mehta, Charmi; Power, Landen; Coffa, Bonnie. 2024. Comparative Toxicity Assessment of the Harm Reduction Potential of Tobacco-Free Oral Nicotine Products. Society of Toxicology, Salt Lake City, UT 2024
- Oh, Sean; Aleksa, Katarina; Ma, Dong; Mehta, Charmi; Power, Landen; Coffa, Bonnie. 2024. Comparative Analysis of 1R6F Reference Cigarette in TK6 and CHO cell lines utilizing Flow cytometry and Manual Counting for the in vitro Micronucleus Assay. TSRC, Atlanta, GA 2024 and CORESTA, Edinburgh, 2024
- Carmines, Ed; Misra, Manoj; Oh., Sean; Hendrik, Giel; Coffa, Bonnie; Aleska, Katarina. 2023. Rapid In Vitro Toxicological Screening Using ToxTracker© to Determine the Effect of Repeated Freeze/Thaw of Combustible Cigarette Extract, TSRC and CORSTA 2023
Timeline
Senior Director Toxicology
Labstat International
06.2024 - Current
Senior Director Commercial Product Development & Regulatory Affairs - Toxicology/Microbiology
Labstat International
06.2022 - 06.2024
General Manager Toxicology
Labstat International
01.2020 - 06.2022
Associate Clinical Laboratory Director
Seroclinix
01.2019 - 04.2020
Toxicology Laboratory Director
Dent Neurological Institute
11.2018 - 04.2020
Toxicologist
Risk Science International
02.2018 - 01.2020
Laboratory Manager
McMaster University
02.2018 - 05.2019
Assistant Professor
University of Toronto
04.2013 - 06.2017
Clinical and R&D Research Associate, PhD candidate
Hospital for Sick Children
11.2007 - 06.2017
Ph.D. - Pharmacology And Toxicology
University of Toronto
Master of Science - Pharmacology And Toxicology
University of Ottawa
Bachelor of Science - Biology & Pharmacology
Mcmaster University
Post-Degree Certificate - Human Health & Environment
Yale University, School of Public Health
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