Experience

Vericel Corporation

• United States
• Biotechnology Research
• 200 - 300 Employee

• Quality Assurance Specialist

  • Nov 2021 - Present

  Cambridge, Massachusetts, United States • Review Endotoxin, Mycoplasma, Sterility, and cell Viability result from QC and release COAs of the Final product. • Perform Final product packaging for patients • Media review and release media in EBR and paper batch record to Manufacturing. • Receiving all Product events and documents for investigation

• Cell therapy manufacturing Associate

  • May 2013 - Nov 2021

  Cambridge, Massachusetts, United States • Qualified in cleanroom gowning • Prepare samples and documentation and submit them to Quality Control • Perform Cell culture production: Autologous cultured Chondrocytes on Porcine Collagen membrane and Epidermal grafts in Bio-safety cabinet • Area clearance and sanitization in BSC, cleanroom, and other lab equipment to release the final product • Communicate, and work with Quality Assurance, Quality control, R&D department

• Patient Coordinator/ Qualified Trainer

  • May 2013 - Nov 2021

  Cambridge, Massachusetts, United States • Collect, and prepare slow/no growth cell data to submit to QC, and QA. • Estimate the maturity of culture by observing the confluency under a microscope. • Prepare/Schedule Trypsinization process for matured culture • Train new hire employees to perform manufacturing procedures in aseptic cleanroom according to established cGMPs, safety regulations, and SOPs.



Cambridge Biomedical Career School

• Biotechnician Trainee

  • Sep 2012 - May 2013

  Cambridge, MA Performed laboratory experiments using molecular and cellular biology and biomedical techniques o Maintained daily log of experiments documenting procedures, material and results o Collected and analyzed data and prepared written reports of findings o Organized and maintained cleanliness of lab space * Knowledge of cGMP, SOP and proper documentation techniques * Balances, pipets, micropipetters, spectrophotometer, centrifuge, PH meter. * Protein Quantitation – Lowry and… Show more Performed laboratory experiments using molecular and cellular biology and biomedical techniques o Maintained daily log of experiments documenting procedures, material and results o Collected and analyzed data and prepared written reports of findings o Organized and maintained cleanliness of lab space * Knowledge of cGMP, SOP and proper documentation techniques * Balances, pipets, micropipetters, spectrophotometer, centrifuge, PH meter. * Protein Quantitation – Lowry and Bradford methods * Buffer (Molarity and percent) and Media Preparation (cell culture and insect) * Column Chromatography – gel filtration and reverse – phase methods. * ELISA (Direct and Indirect) – performed simulated HIV ELISA to detect anti - HIV antibodies. * DNA fingerprinting – restriction enzyme digestion and separation by gel electrophoresis * Bacterial Transformation – transformed E. coli with ampicillin – resistant plasmid and evaluated growth. * Cell culture methods – prepared media using sterile technique, cell counting by using hemocytometer Show less