Experience

ImmunoGen, Inc.

• United States
• Biotechnology Research
• 200 - 300 Employee

• Senior Manager Quality Product Testing

  • Apr 2022 - Present

  Reviewed and approved method transfer, qualification, validation protocols, reports and test methods to ensure compliance with applicable compendia, ICH guidelines and regulatory requirements. Collaborated with the Quality team to qualify CMOs/CTLs and monitor their performance Reviewed and approved batch records. Collaborated with CMC, Analytical Development and Regulatory Affairs departments for product release, expiry date assignments and risk assessments. Audited Product Test Data Packages from CTL/CMO (Release, Stability, Reference Standard Qualification). Verifed/authorized stability data in SLIM (Stability Lab Information Manager) Prepared/reviewed stability data trend analysis and present it to the Stability Review Committee. Documented QC data review metrics for assigned to CMO/CTL (e.g. GDP, data integrity issues observed, untimely data package deliveries). Supported initial INDs, IND amendments, product registrations and Annual Product Reviews. Reviewed and approved Lab Event, Deviation or OOS related to Product Test Data Packages from CTL/CMO Reviewed and approved stability study protocols and associated sampling plans, including plans for sample shipment, if required. Owned change controls, quality events and CAPAs related to product testing events per company procedures Authored, reviewed and approved SOP’s and product specification documents. Show less



Revance

• United States
• Biotechnology Research
• 400 - 500 Employee

• Sr. Manager QC Analytical

  • Mar 2021 - Jul 2021

  • Planned, organized and directed the activities related to QC Analytical and Stability Groups to ensure timely completion of tasks • Oversaw the performance of the QC group to ensure that products and processes meet company, regulatory and CDC requirements • Managed staffing, training and development of subordinates • Provided technical assistance and direction to the other CMC functional groups • Provided quality control oversight to contract testing laboratories • Directed the investigation of OOS and aberrant results in product and raw material testing. Resolved nature of the cause, impact, disposition, and corrective actions • Ensured the efficient use of resources to achieve department quality and operation plan objectives • Represented QC on cross-functional teams which address analytical issues and process improvements Show less



Stevanato Group

• Italy
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Scientist

  • Aug 2020 - Mar 2021



Takeda

• Japan
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Analytical Chemist

  • Jul 2018 - Mar 2020

  • Developed analytical methods for vaccine projects. • Troubleshot and optimized existing methods for QC use. • Executed method validation and qualification protocols. • Managed/Monitored CMO’s, CRO's, and vendors for reference materials and instrument qualification needs. • Initiated/led root cause analysis, OOS/OOT investigations. • Authored/reviewed SOP’s, reports, and protocols. • Performed protein and VLP characterization tests by using HPLC, SDS-PAGE, Western Blot, Particle size, UHPLC/MS, and DLS techniques. • Carried out quantification tests of drug substances and products with HPLC(Agilent/ChemStation) RP, CEX, and SEC (single/dual column) techniques with DAD, RI, and MALS detectors. • Troubleshot and maintained laboratory instruments and equipment. • Trained/Supervised junior/senior scientists in different analytical techniques and methods. • Entered results in Electronic notebook (ELN), LIMS, and Sharepoint software and presented the data (JMP) at Analytical Development group meetings. Show less



AbbVie

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• QC Chemist III

  • May 2017 - May 2018

  • Analyzed raw materials using the United States, European, and Japanese pharmacopeias. • Performed FTIR analysis for compendial, non-compendial materials, media, resins, and bottle samples. • Carried out TruScan, osmolality, and optical rotation tests for raw materials. • Completed identification tests with various wet chemistry techniques. • Tested gas and water samples, according to SOPs. • Sampled raw materials in a sterile environment. • Performed calibration of FTIR and ATR instruments. • Established the LIMS system for the QC Raw Materials group. • Leaded OOS/ OOT investigations, CAPA, deviations, and provided technical/theoretical support. • Managed CTL’s and CMO’s for outside testing and reviewed data. • Contacted the vendors for material specifications. Show less



Long Island University

• United States
• Higher Education
• 700 & Above Employee

• Teaching Assistant at department of Pharmaceutical sciences

  • Jan 2016 - Jan 2017



Bristol Myers Squibb

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Associate QC Scientist

  • Jul 2015 - Jan 2016

  • Analyzed in-process, finished products, and stability samples using U.S Pharmacopoeia (USP), SOPs, and in-house testing methods. • Utilized HPLC (Waters-Empower 2-3) with a variety of detectors and chromatographic techniques including size exclusion, cation exchange, and affinity chromatography. • Worked with databases and laboratory applications, including LIMS, Smartlab, Trackwise. • Troubleshoot and calibrated instruments. • Enabled an adequate supply of standards and reagents as needed through the BMS global network. • Performed routine data review and verification. • Participated and presented in team meetings to provide support and troubleshooting for protocols. Show less



Contract Pharmacal Corp

• United States
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• QC Chemist

  • Sep 2013 - Feb 2015

  • Performed analysis of in-process, finished product stability, and R&D samples using Pharmacopoeia (USP), SOPs, and in-house testing methods. Utilized HPLC (Waters&Hitachi-Empower 2), UPLC, Dissolution, UV-Vis spectrophotometer, TLC, KF titrator, and wet chemical techniques. • Tested drug substance and product impurity characterization and stability testing. • Conducted raw materials analysis by using HPLC, FT-IR, and wet chemistry techniques. • Multi-element analysis with ICP-OES. • Performed analytical method transfer, method validation, process validation, and cleaning validation testing using HPLC and other instruments. • Qualified controlled substances and in-house standards. • Troubleshoot and calibrated laboratory instruments. • Provided analytical support for formulation development. Reviewed laboratory data and reports as needed. • Demonstrated solid knowledge of GMP and FDA guidance. Show less



Long Island University

• United States
• Higher Education
• 700 & Above Employee

• Research Assistant

  • Sep 2009 - Aug 2012

  • Developed 4 HPLC methods for formaldehyde analysis by using HPLC (Agilent 1200) with DAD and FLD detectors, UV-VIS, and fluorescence spectrophotometer.• Conducted extensive research on fructose degradation products and antioxidant properties of fruits.

• Teaching Assistant

  • Sep 2009 - Aug 2012



Cimtas Steel Processing Co.

• Quality Control Analyst

  • Sep 2001 - May 2003

  • Performed elemental (carbon, sulfur, oxygen, nitrogen, and hydrogen) analysis by using spectroscopy methods.• Carried out corrosion tests, re-melting, conductivity, and alloy analysis.• Analyzed raw materials and finished product analysis with titrator, pH meter, and other wet chemistry techniques under ISO 9000 conditions.• Documented all quality control analysis and instrument calibrations.

• Intern

  • Jun 2001 - Aug 2001

  • Mastery of basic element analysis, corrosion, conductivity, re-melting, spectroscopy and wet chemistry techniques. • Internship resulted in job offer as quality control analyst.



Novartis

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Intern

  • Jun 2000 - Jul 2000

  • UV-Vis and HPLC analysis of agricultural implements(pesticides, herbicides, and fungicides), had been learned. • Performed raw materials and finished product analysis. • UV-Vis and HPLC analysis of agricultural implements(pesticides, herbicides, and fungicides), had been learned. • Performed raw materials and finished product analysis.



Türk Tuborg

• Türkiye
• Food and Beverage Services
• 700 & Above Employee

• Quality Control Analyst

  • Jun 1997 - Mar 1998

  • Performed high complexity tests (Oxygen, carbon dioxide, nitrogen tests, protein analysis, viscosity tests, acid-base tests) by using HPLC, Uv-Vis spectrophotometer, titrator, pH meter, and other wet chemistry techniques.• Carried out microbiology tests, such as yeast analysis, microscopic cell counting.• Analyzed raw materials and finished products under ISO 9000 regulations.• Documented and quality control activities.

• Intern

  • Sep 1996 - May 1997

  • A mandotorial vocational high school internship during the last year of the school, 3 days in a week.• UV-Vis, HPLC, wet chemistry, microbiology and quality control analysis of raw materials and finished products under ISO standards had been learnt.• This internship ended up with a job offer as quality control analyst.