Ann Szajkovics
Lindenhurst,IL
Summary
Senior Scientist with expertise in IVDR compliance and technical documentation. Led analytical development and validation efforts while fostering cross-functional collaboration. Specialized in chromatography techniques and change control to enhance product reliability and regulatory adherence. Focused on mentoring and developing team capabilities.
Overview
26
26
years of professional experience
Work History
Senior Scientist Operations II, Technical Operations
ABBOTT LABORATORIES
Abbott Park, IL
08.2019 - Current
- Support all Clinical Chemistry and Immunoassay products produced by ADD (TPM and Abbott LM) in the transition from IVDD (In-Vitro Device Directive) to IVDR (In-Vitro Device Regulation) on ARCHITECT c8000 and Alinity c and i platforms.
- Evaluate, remediate, and act as technical author and approver for technical documentation including Design Plan (DP) deliverables, Design History Files (DHF), Product Change Notices (PCN), labeling changes, Risk Management Assessments, updating technical file content (PEA, PEC, Stability, GSPr, PRD, Traceability Matrix, etc.), product performance (analytical and clinical) and post-market surveillance.
- Served as subject matter expert for all related processes design verification activities of reanalysis of existing Precision data to IVDR Reproducibility requirements and mentored/trained other group members. Worked closely with the Statistics team to develop a process to analyze data and create protocols.
- Engage in CFTs and maintain contact with TPMs and other global ADD sites in their implementation of IVDR.
- Utilize PEAR (admin access), APLM (approver/author), ALMS, ePAS (author/initiator), EDMS, IRIS (approver/author), Trackwise, eNovator.
Scientist - Contractor, Abbott Diagnostics Division
ABBOTT LABORATORIES
Abbott Park, IL
07.2018 - 08.2019
- Authored and initiated Change Requests (CR) for Change Management Group to enhance document control processes.
- Completed Design Plans (DP) in collaboration with cross-functional teams to implement improvements on site test methods and manufacturing processes, ensuring compliance with regulatory standards.
- Created and maintained PSCPs for Architect to Alinity conversion, coordinating global and US-only releases.
- Utilized ePAS, DMS, SAP, APLM, ALMS, Lotus Notes, and GS1 for document management and data tracking.
Chemist - Contractor, NBE
ABBVIE
North Chicago, IL
06.2017 - 07.2018
- Conducted formulation and analytical development for antibody drug conjugates (ADC), monoclonal antibodies, and small molecules using HPLC techniques (SEC, HIC, RP, DR, linker toxin; iCE; SoloVPE).
- Developed HPLC and GC methods for laboratory assays.
- Established stability studies for chemical and physical properties under various manufacturing conditions, including freeze/thaw, mixing, filtration, filling, and lyophilization.
Senior Protein Chemist, Health & Nutrition
SGS LIFE SCIENCES
Lincolnshire, IL
04.2016 - 06.2017
- GMP small/large molecule method development using HPLC, GC and CE/cIEF (SEC, HIC, RP, RI)
- Conducted stability and routine testing of proteins, small molecules, sugars, and amino acids per USP/EP monographs using HPLC, CE, and other wet chemistry methods to ensure compliance and quality.
- Mentored junior chemists in CE, HPLC, and Empower software, enhancing their technical skills and knowledge.
- Performed dissolution testing of pharmaceutical products, ensuring release specifications and batch-to-batch consistency.
Scientist - Contractor, Abbott Diagnostics Division
ABBOTT LABORATORIES
Abbott Park, IL
09.2015 - 04.2016
- Conducted assay development for Abbott Laboratories diagnostic research programs.
- Developed and validated methods for large molecules and in-vivo produced antibodies/serum using HPLC (GPC, RP, Affinity-based), SDS-PAGE, Western Blot, and BCA methods to enhance QC processes.
- Collaborated with Manufacturing and Quality Assurance teams to ensure compliance and quality for IA/CC products.
Research Scientist Contractor, Renal Solutions Product Support
BAXTER HEALTHCARE
Round Lake, IL
07.2014 - 09.2015
- Planned, executed, and managed cross-disciplinary projects/programs, coordinating efforts to achieve project objectives and deliverables.
- Authored and initiated change requests in Trackwise8, collaborating with project management teams to ensure compliance and project alignment.
Scientist Contractor, Global Biologics R&D
HOSPIRA
Lake Forest, IL
04.2013 - 07.2014
- Conducted tests on impurity and reference standards, performed gap analysis for analytical methods, and executed drug product release and stability testing (SEC, peptide mapping, potency/impurity, oxidized species, and other standard techniques), documenting results using LIMS.
- Executed UPLC and HPLC analysis for glycan and glycoprotein characterization, including HILIC, WAX, double digest, and SDS-PAGE.
- Conducted method development and validation of HPLC/UPLC methods for biosimilar product (Epogen) analysis.
Scientist Contractor, Marketed Product Support
HOSPIRA
Lake Forest, IL
10.2012 - 04.2013
- Developed and validated methods for new and existing small molecule products, ensuring reliability through stability studies.
- Performed HPLC, titration, KF, and other wet chemistry methods, maintaining compliance with GMP standards.
- Maintained accurate records of experimental protocols and results in accordance with regulatory requirements.
Scientist Contractor, R&D and QA
WELLNESS INDICATORS
Wauconda, IL
01.2012 - 10.2012
- Developed and validated methods, performed laboratory work, wrote SOPs, and prepared Excel templates and linear/non-linear curve data for clinical trials and FDA submission of Class 1 medical device for start-up company.
- Led development of urine lateral flow test to analyze several analytes, aiding in determining if patients are within normal ranges or require further diagnostics.
- Maintained laboratory protocols, documentation, and quality control records.
Research Associate Contractor, Technology - Physical and Chemical
BAXTER HEALTHCARE
Round Lake, IL
06.2011 - 01.2012
- Developed and validated small molecule analytical methods, ensuring compliance with regulatory standards for new pharmaceutical products.
- Supported product maintenance and quality assurance through HPLC, UPLC, amino acid derivatization, TLC, and other wet chemistry methods.
- Participated in the publication of an article in the Journal of Pharmaceutical and Biomedical Analysis.
Scientist - Abbott Diagnostics Division
ABBOTT LABORATORIES
Abbott Park, IL
11.2003 - 01.2011
- Developed and validated the IgG quantitation method on Waters HPLC that was transferred for use in Quality Assurance, Manufacturing, Biological Process Development, R&D, Abbott global sites, and cross-divisionally in Global Pharmaceutical R&D.
- Developed and validated methods, authored and amended documents for cell- or in-vivo-produced antibodies and serum, enhancing product quality and regulatory adherence.
- Trained global teams on Waters HPLC operation and protocols, fostering cross-divisional knowledge sharing.
- Operated various laboratory techniques including HPLC (Affinity-based, GPC), SDS-PAGE, and ELISA to support biochemical analyses.
- Supported manufacturing and quality assurance for IACC division products, ensuring compliance and reliability for infectious disease diagnostics.
Associate Scientist, Abbott Diagnostics Division
ABBOTT LABORATORIES
Abbott Park, IL
01.2005 - 01.2007
- Developed cell culture processes for manufacturing groups using WAVE, perfusion, and flask bioreactors on CHO and other cell lines, enhancing production capabilities.
- Executed cell line qualification testing of master cell banks to ensure compliance with regulatory standards.
- Performed Affinity-based HPLC IgG assay to support analytical development and quality control efforts.
Product Specialist, Abbott Molecular Division
ABBOTT LABORATORIES
Abbott Park, IL
01.2003 - 01.2005
- Manufactured bulk reagents for diagnostic kits, enabling accurate disease detection.
- Maintained accurate records in Abbott Laboratories systems.
- Performed manufacturing in a sterile positive laboratory suite.
Research Technician - Permanent, Biochemistry Department
MIDWESTERN UNIVERSITY
Downers Grove, IL
03.2001 - 11.2003
- Analyzed data on estrogen's effects in breast cancer and bone degeneration across mammalian and cancer cell lines to support publications, grants, and poster presentations.
- Investigated apoptosis and impacts of testosterone, DDE, and DHT using in-vivo and in-vitro mouse models and cancer cell lines.
- Utilized following techniques: PCR, western, southern, northern blot, RNA, DNA, protein isolation, RNase Protection Assay, mammalian and cancer cell culture, fluorescence microscopy, gene array, E. coli transformation, immunoprecipitation, live animal handling, 3 HTdR cell proliferation, P32 labeling.
Education
Bachelor of Science - Biology
Northern Illinois University
DeKalb, ILSkills
- IVDR compliance
- Technical documentation
- Analytical development and validation
- Change control
- Statistical analysis
- Chromatography techniques
- Biochemical, molecular, cellular techniques
- Cross functional collaboration
- APLM, TrackWise, EDMS, IRIS
- Quality systems
Timeline
Senior Scientist Operations II, Technical Operations
ABBOTT LABORATORIES
08.2019 - Current
Scientist - Contractor, Abbott Diagnostics Division
ABBOTT LABORATORIES
07.2018 - 08.2019
Chemist - Contractor, NBE
ABBVIE
06.2017 - 07.2018
Senior Protein Chemist, Health & Nutrition
SGS LIFE SCIENCES
04.2016 - 06.2017
Scientist - Contractor, Abbott Diagnostics Division
ABBOTT LABORATORIES
09.2015 - 04.2016
Research Scientist Contractor, Renal Solutions Product Support
BAXTER HEALTHCARE
07.2014 - 09.2015
Scientist Contractor, Global Biologics R&D
HOSPIRA
04.2013 - 07.2014
Scientist Contractor, Marketed Product Support
HOSPIRA
10.2012 - 04.2013
Scientist Contractor, R&D and QA
WELLNESS INDICATORS
01.2012 - 10.2012
Research Associate Contractor, Technology - Physical and Chemical
BAXTER HEALTHCARE
06.2011 - 01.2012
Associate Scientist, Abbott Diagnostics Division
ABBOTT LABORATORIES
01.2005 - 01.2007
Scientist - Abbott Diagnostics Division
ABBOTT LABORATORIES
11.2003 - 01.2011
Product Specialist, Abbott Molecular Division
ABBOTT LABORATORIES
01.2003 - 01.2005
Research Technician - Permanent, Biochemistry Department
MIDWESTERN UNIVERSITY
03.2001 - 11.2003
Bachelor of Science - Biology
Northern Illinois University