Hira Mazhar Email & Phone Number

Seattle, Washington, United States

• Handled the review and approval of client-based project documents for in-process, stability sample, and finished product studies conducted for Drug Substance and Drug Product lot disposition following SOP. • Issued test forms for the Quality Control department for performing routine testing in a timely manner. • Ensured that stability study reviews are executed in a timely manner ensuring continuous Smartsheet tracking. • Successfully reviewed and approved client stability study… Show more • Handled the review and approval of client-based project documents for in-process, stability sample, and finished product studies conducted for Drug Substance and Drug Product lot disposition following SOP. • Issued test forms for the Quality Control department for performing routine testing in a timely manner. • Ensured that stability study reviews are executed in a timely manner ensuring continuous Smartsheet tracking. • Successfully reviewed and approved client stability study packets from initial review, to approval, scan, verification, and archival process for assigned client products. • Assisted in monthly Compliance walkthroughs of all GMP areas ensuring regulatory adherence, risk management and continual improvement. • Interacted with analysts/associates/scientists/managers in QC and PD in routine work and problem identification and resolution. Show less

Bothell, Washington, United States

• Directed the hiring management activities to expand team support by successfully onboarding two new team members. • Supervised a team of four QC associates by managing performance activities, including weekly meetings and follow-up with the team to improve performance and duties. • Managed client specific project studies utilizing Smartsheet to ensure all product lot release ensues in a timely manner. • Maintained training and procedures of current standardized assays, performing… Show more • Directed the hiring management activities to expand team support by successfully onboarding two new team members. • Supervised a team of four QC associates by managing performance activities, including weekly meetings and follow-up with the team to improve performance and duties. • Managed client specific project studies utilizing Smartsheet to ensure all product lot release ensues in a timely manner. • Maintained training and procedures of current standardized assays, performing sample testing for the lot release on all assigned tasks per GMP requirements. • Reported unexpected data trends, OOS events and risks accordingly, driving support from management. • Successfully obtained all training Qualifications for essential work performance and review of client specific assays including Microbiology Assays (TOC/Conductivity, Bioburden, Cell Culture), Chemistry Assays (HPLC titers, UV-VIS Spectroscopy, pH, Osmolarity) Bioassays (Elisa), and Sample Management activities (LIMS). Show less

Houston, Texas, United States

• Executed analytical studies to optimize procedures for the Flow Cytometry (Cytek NL-3000) instrument (inclusive of immunophenotyping, titration studies, and panel design processes). • Effectuated aseptic techniques for sample handling and cryopreservation.• Perfected successful revision and approval of Guide to Pipetting SOP and Test Method (TM) with adherence to GDP and ICH guidelines. • Performed monthly and quarterly lab upkeep cleaning activities and logbook reviews ensuring… Show more • Executed analytical studies to optimize procedures for the Flow Cytometry (Cytek NL-3000) instrument (inclusive of immunophenotyping, titration studies, and panel design processes). • Effectuated aseptic techniques for sample handling and cryopreservation.• Perfected successful revision and approval of Guide to Pipetting SOP and Test Method (TM) with adherence to GDP and ICH guidelines. • Performed monthly and quarterly lab upkeep cleaning activities and logbook reviews ensuring audit compliance. • Organized project-specific requirements (maintenance, timely sample shipment preparation). Show less

Texas, United States

• Spearheaded two client projects by training team members on various project-based assays (inclusive of mycoplasma, endotoxin, Elisa, and Flow Cytometry assay) while leading GMP run-throughs before final product release. • Managed the review and approval process of all QC testing (inclusive of SOPs, and TMs) pertaining to the two client projects managed. • Ensured timely maintenance, calibration, and release of newly onboarded equipment (2 new Flow Cytometers). This entailed… Show more • Spearheaded two client projects by training team members on various project-based assays (inclusive of mycoplasma, endotoxin, Elisa, and Flow Cytometry assay) while leading GMP run-throughs before final product release. • Managed the review and approval process of all QC testing (inclusive of SOPs, and TMs) pertaining to the two client projects managed. • Ensured timely maintenance, calibration, and release of newly onboarded equipment (2 new Flow Cytometers). This entailed interfacing with multiple departments including Calibration, Validation, Process Development and Quality Assurance team to get approval of all equipment related QC documents including user requirement specifications (URS) and operation, maintenance, and calibration (OMC) documentation establishment, review, and approval processes. • Successfully developed a logbook for the flow cytometer daily use. • Drafted all master item Specifications (MIS) of newly incorporated project supplies for the two client projects managed ensuring contractual obligations. Show less

1901 East Road

• Managed multiple successful projects pertaining to studies relevant to selective PROTACs targeting lung cancer. • Improved upon techniques while establishing project specific testing including stable cell line generation, cancer cell line maintenance, cloning plasmid vector and plasmid transformation, western blotting, Incucyte proliferation assays, qPCR and PCR, transfection, transduction, and cryopreserving of lung cancer cells.

Houston, Texas Area

• Successfully Co-authored publication referenced by running various project-specific assays utilizing techniques including protein isolation and quantification, histology image analysis, immunoprecipitation, SDS-PAGE, DNA and RNA isolation / quantification, DNA transfection, agarose gel electrophoresis, plasmid isolation, HUVEC isolation, tissue and cell culture, and cell count (hemocytometer).

Lowell, Massachusetts

Evaluated oxidative stress markers within the body fluids of patients who work with photocopiers. Measured lipids present in livers and plasma of mice fed diet containing oxidized linoleic acid to confirm dietary consumption in lowering triglyceride levels. Leveraged techniques such as: HPLC, GC-MS, UV-VIS/IR spectrophotometry, and lipid extraction.Further Investigated post-mortem and quantitative distribution of lipids in the Liver and Plasma of Mice fed diet containing oxidized Lineloic… Show more Evaluated oxidative stress markers within the body fluids of patients who work with photocopiers. Measured lipids present in livers and plasma of mice fed diet containing oxidized linoleic acid to confirm dietary consumption in lowering triglyceride levels. Leveraged techniques such as: HPLC, GC-MS, UV-VIS/IR spectrophotometry, and lipid extraction.Further Investigated post-mortem and quantitative distribution of lipids in the Liver and Plasma of Mice fed diet containing oxidized Lineloic acid. This approach was used to confirm dietary consumption of Linoleic acid in lowering triglyceride levels and thus working towards the improvement of atherosclerotic disease. Utilized techniques such as GC-MS and lipid extraction. Show less

Lowell, Massachusetts, United States

Lowell, Massachusetts, United States

Lowell, Massachusetts, United States

Master'S Degree, Pharmaceutical Sciences, 3.85

Activities and Societies: Graduate Student Ambassador Lowell, MA Summa cum laude

Pre-Medicine, Biology

Lowell, MA Completed Coursework: Cell Culture Organic Chemistry, Good Manufacturing Practices (GMP), Drug Metabolism, Biostatistics.

H.S Diploma, 3.8 Gpa

National Honor Society.