Ana Kvesic

• SME for purification of lentiviral vector material using TFF, AEX chromatography (AKTA FPLC systems) and depth filtration – RSM and manufacturing scale
• Actively working on process improvements and investigation of non-conformances in Manufacturing
• Authoring and reviewing protocols, reports, and procedures for the purpose of regulatory filings, RSM qualifications, and tech transfer.
• Interpreting and contextualizing data sets generated by various analytical techniques, including PCR and ELISA assays.
• Leading projects for the evaluation of new technologies – review literature, communicating with vendors, planning and executing experiments, as well as presenting the data and technology to the group.
• Leading accurate and timely data capture into the ELN.
• Basic skills in process data analysis using statistical models and statistical software, JMP.
• Training other team members.

• Process engineer of final form production of the small molecules.
• Leading day-to-day production activities.
• Leading tech transfer as a manufacturing representative, which includes preparation of batch records, validation records, and collaboration with cross-functional teams throughout the organization to ensure successful implementation of projects (project management, process validation, Quality and RA)
• Analyzed operational data to determine the root causes of manufacturing deviations. Conducted deviation investigations and CAPAs in TrackWise.
• Authored and refined site SOPs and batch records (BRs).
• Lead process optimization initiatives, driving continuous improvement in production methodologies, and resource utilization.

• SME for HPLC and GC techniques for small-molecule APIs.
• Lead day-to-day activities in the chromatography lab.
• Lead investigation and nonconformance activities (Trackwise).
• Lead of analytical tech transfers.
• Authoring and editing SOPs, as well as analytical, validation protocols, and reports.
• Troubleshooting
• Led the analytical tech transfer and implementation of the production of the first synthetic peptide API to the site.

- New instruments and methodologies for evaluation and implementation in the QC lab.

- Providing support to the production with manufacturing-scale preparative chromatography.

- Won an award for Best Project in TEVA Croatia in 2018 for the project “Extraordinary Transfer” as the analytical department lead.

• Participated in internal assessments and audits.
• I was a member of the EH&S site team, serving as the safety champion.
• LC-MS Basics