Developing mass spectrometry-based targeted and untargeted metabolomic platform. Improved analytical capabilities by increasing sample throughput Identifying alternative technologies: expanding to proteomics with skyline. Established role of point person for method development and validation, serving on multiple cross-functional teams bridging engineering, bioprocessing, biology, DSP, and production departments in both small molecule and oligonucleotide analysis
- Analytical Scientist at GreenLight Biosciences
- Research Associate II at UMass Medical School
- Postdoctoral Researcher at UT Southwestern Medical Center
- Research Assistant at UT ARLINGTON
3 years, 6 months at this Job
- Ph.D. - Analytical Chemistry
- M.Sc. - Analytical Chemistry
- M.Sc. - Environmental Technology
- B.E. - Chemical Technology and Petroleum
Implements analytical methodologies under minimum supervision by employing various analytical techniques and instrumentation (HPLC, GC, IC, LC etc...) Records, reports and reviews test results; prepares documentation in compliance with regulatory requirements. Performs all testing in compliance with cGMP. Performs all testing in compliance with current safety regulations. Conducts QC laboratory investigations. Performs calibration and maintenance of analytical instruments as required. Performs training and provides technical support to analysts as required. Writes, revises and implements procedures, protocols and validation reports. Completes any other duties assigned by QC management
- Analytical Scientist at Noven Pharmaceutical
- LCMS Technologist & Certifying Scientist at Testing Matters Toxicology
- QC Chemist, LCMS Technologist and Method Optimization at Toxicology Lab Solutions
- LCMS Technologist & Certifying Scientist and Health & Safety Officer at Calloway Labs
1 year, 1 month at this Job
- Certificate - Data Analytics
- Bachelor of Science in Chemistry - Mathematics
• Performing validation experiments as per approved method validation protocols, company SOP and ICH guidelines.
• Performing in-process, finished products/release and stability testing of dosage forms as per the approved methods.
• Performing analytical method transfer from R&D and QC laboratory for newly validated methods, method validation protocols, method development and validation reports.
• Independently developing analytical method for drug substances, drug product, preservatives and degradants / impurities in the drug products.
• Perform Out of specification and Out of Trend investigations.
• Responsible for chemistry, Manufacturing and Controls (CMC) documentation required for NDA/ANDA submissions.
• Performing analytical method transfer from R&D to QC laboratory for newly validated methods.
• Independently Writing/Revising analytical methods, method validation protocols, method development and validation reports, method transfer protocols/reports, in-vitro comparison reports.
• Performing identification studies for unknown's/ knowns impurities in drug products using LC/MS, GC/MS, UPLC, Raman Spectroscopy, FTIR.
• Documenting all activities in the appropriate laboratory notebooks, including maintenance of SOP's, training and equipment validation or maintenance.
• Execute all functions in accordance with current FDA regulations, ICH guidelines, USP methodologies, cGLPs and Company SOPs.
• Thorough Knowledge of Compliance wire, CDMS, Track wise, TotalChrom, Chemstation, iStability LIMS
- Analytical Scientist at Akorn Pharmaceuticals
- Associate Analytical Scientist at Catalent Pharma Solution LLC
- Quality Control Chemist at Appco Pharma LLC
1 year, 10 months at this Job
- Master - Pharmaceutics
- Bachelor - Pharmacy
• Schedule analytical testing of GMP drug Product and Process Development activities
• Implement and manage Environmental Monitoring program
• Lot release testing of CAR-T and Stem Cell therapies (PCR, Flow Cytometry, Mycoplasma, Sterility)
• Authoring and Implementing Lab Guidance policies
• Train analytical staff on QC assays
• Optimize analytical assays and revise them accordingly
• Lead all QC investigations for deviations, excursions, and OOS
- Quality Control Analytical Scientist at Stanford University, Laboratory for Cell and Gene Medicine
- Quality Control Analyst III at Revance Therapeutics, Inc
- Cell Therapy Specialist III at Progenitor Cell Therapy
- Quality Control Associate at Cognate Bioservices
2 years at this Job
- Bachelor of Science - Biology
- Master of Science - Microbiology
Analytics: Subject matter expert for cell-based and biochemical assays in CMC
• Project leader for a cell-based potency assay optimization and method transfer to CMO.
• Developed and validated titer analysis SOP for Tox and GMP production.
• Developed methods for charge and size analysis of biosimilars by cIEF and CE-SDS
• Developed and transferred a sucrose assay for in-process control testing.
• SOPs method development, qualification, assay transfer and approval.
• Characterized biosimilars' concentrations by OctetQK384 system and Protein A-HPLC.
• Characterized biosimilars' sizes by RP-HPLC and SEC-HPLC. Upstream process development
• Adapted a suspension cell line to eight different commercial media.
• Carried out stable cell line stability studies by FACS and growth studies.
• Developed a high-yield cell culture platform for fed-batch cultures.
• Established and characterized a therapeutic target in three bacterial hosts.
• Generated research cell banks for upstream process development.
• carried out titer determination for samples from bioreactor runs. Formulation development
• Completed pH and buffer screen for 5 different buffers with pH ranging from 4-7.5.
• Completed 18 excipients screen in 2 different pH buffers.
• Characterized pH, buffer and excipient screens by nanoDSF, DSC and DLS.
• Carried out viscosity measurement for high concentration biosimilar samples.
• Completed sub-visible particle analysis of UF/DF DS samples by Micro Flow Imaging. Business development lead for selecting CRO/CMOs for CMC outsourcing services.
• Initiated and established three research and one commercial licenses agreements. CMC QA and document control
• Document review on batch production records, scale-up reports and manufacturing reports.
• Generated development reports, assay protocol and method SOPs
• Quality assurance review on executed batch production records. Lab set-up
• Established an upstream process development lab.
• Maintenance of Nova Bioanalyzer, Beckman ViCell and Infors Shaker Incubators.
- Analytical Scientist at NGM Biopharmaceuticals, Inc
- Private Tutor at AP Biology
- Contract Scientist at Applied Viromics
- Managed a research associate at
2 years at this Job
- - Postdoctoral Fellow
- Ph.D. in Biochemistry - Biochemistry
- M.S. in Cell Biology - Cell Biology
- B.S. in Biochemistry - Biochemistry
- Certificate of Achievement
• Developed, Validated, and Performed analytical methods
• Participating OOS (Out of Spec) project: including investigation, data organization and reporting
• Writing, reviewing, and issuing SOP
• Peer review documentation of other chemist to ensure cGMP compliance
• Inventory tracking for control and non-control materials
- Senior Analytical Scientist at PHARMEDIUM PHARMACEUTICAL
- Analytical Scientist at UPM PHARMACEUTICAL
- QC Analytical Scientist at BERG PHARMACEUTICAL
- CONTRACTOR at AVECIA BIOTECH
2 years, 3 months at this Job
- Masters in Analytical Chemistry - Analytical Chemistry
- Masters in Bio-Chemistry - Bio-Chemistry
Dept.: Pharma Polymers
Duties & Responsibilities:
• To perform assigned sampling, physical, chemical tests and assay on raw materials, active pharmaceutical ingredients, in process, finished and stability products, using various wet chemicals, physical and various sophisticated laboratory analytical Instruments like HPLC (Such as Agilant 1100, Shimandzu Prominance-I LC 2030C 3D Empower 3 & Waters Allience 2695 PDA2998 with Empower 2 Software ), UV-Visible Spectroscopy System, FTIR with Microscope, pH meter, Distek Fiber Optic Dissolution with Autosampler, DSC and other routine Analytical instruments as per USP monograph / In-house / any other Compendial monographs.
• Independently plan and make adequate inventory of test reagents and solutions to perform work, assure supplies are ordered as needed to perform assigned work.
• Independently plan and execute testing to meet established time lines. Perform more complicated testing with supervisory direction.
• Perform routine and non-routine testing of raw materials, in process, finished products and stability samples.
• Provide analytical support to R & D departments.
• To record data and results as specified in documentation procedures.
• To develop and validates analytical method.
• Controlling and maintaining the laboratory inventory.
• Experimental design, data interpretation, accurate record keeping, documentation for each activity and laboratory audit.
• Preparation, handling, storage, stock maintain and inventory of various chemical reagents and solution.
• Work efficiently in a team setting as well as independently
• To comply with all regulatory/in-house (DEA, ICH, OSHA, ACGIH etc.) requirements when performing the assigned activity.
• To perform troubleshooting and investigation under the direction of a supervisor/senior Analytical chemist.
• Manually Cleaning Laboratory Glassware and Disposal of Laboratory Waste
• Responsible for performing industrial hygiene activities for handling of potent compounds.
- Analytical Scientist & IH Technician at Evonik Corporation
- Research Associate -A at
- Lab Analyst at Raritan Pharmaceuticals
- Assistant Chemist - Quality Control at Lupin Pharmaceuticals Ltd
4 years, 10 months at this Job
- - Industrial Hygiene Technician
- Master in Science - Pharmaceutical Chemistry
- Bachelor in Science - Pharmaceutical Science
- Associate in Science - Pharmaceutical Science
Analytical Project Lead for five GMP product programs
○ Coordinate analytical needs between customer, AMPAC integrated project team, and AMPAC
Analytical Method Development (AMD) group
○ Direct and oversee analytical and review workflow of junior scientists
○ Oversee transfer of customer analytical methods, develop and validate requisite analytical methods
○ Draft and review SOPs, specifications, and transfer/validation protocols and reports
● AMD coordinator for Mettler Toledo LabX implementation (21 CFR 11 compliant MT instrument control and data handling software)
● GC, GC-MS, HPLC, LC-MS, UPLC, and ICP-MS analytical method development and validation
● Chromeleon, Qtegra, and Chemstation instrument control and data analysis experience
● Instrumentation troubleshooting and maintenance
● Thermo Fisher Scientific iCAP Q/RQ instrumentation operation and maintenance course
- Analytical Scientist II at AMPAC Fine Chemicals
- Graduate Student Researcher at Zink Lab at UCLA
- Research Fellow -Tobacco Analysis Group and VOC and Perchlorate Group at ORISE Fellowship at United States Center for Disease Control and Prevention
2 years, 9 months at this Job
- M.S. - Materials Chemistry
Method transfer and method validation Specialist. Responsible for executing protocols and reporting for new products. Gap assessment, risk assessment and residual solvent for new raw materials.
- Analytical Scientist at Catalent Pharma Solutions
- Method Transfer and Validation Specialist - Analytical Service Department at Patheon Pharmaceutical
- QA Compliance Specialist - QA Department at Patheon Pharmaceutical
- Senior Analyst III - Raw Materials Qc Deparment at Patheon Pharmaceutical
1 year, 4 months at this Job
- Bachelor - Chemistry
• Provided analytical support to pharmaceutical product development in cGMP/GLP environment
• Developed methods using HPLC, and ion chromatography (IC) to analyze different dosages form
• Validated the methods as per ICH guidelines for submission to regulatory agency and method transfer
• Developed and optimized IVRT method for various dosages form including cream, suspensions, emulsions
• Working as a subject matter expert (SME) (chemistry and analytical chemistry) to draft response to FDA deficiencies; complete response Letter (CRL) and Information request (IR) for various projects
• Reviewed CMC section to prepare response and planned additional studies to address various queries/questions from regulatory agencies and drafted response for FDA deficiency
• Prepared analytical method development report, various protocols and method validation report
• Wrote and Reviewed the CMC section for submission to regulatory agency (FDA)
• Worked as subject matter expert (SME) with CROs for various projects and review test results
• Maintained through and complete documentation in laboratory note book and log books
- Analytical Scientist II, R&D at Akorn, Inc
- Scientist-Analytical R&D at Teva Pharmaceuticals
- Adjunct Lecturer & Graduate Teaching Assistant at College of Staten Island
- Graduate Research Assistant at City University of New York
2 years, 1 month at this Job
- Ph.D. in Chemistry - Chemistry, The Graduate Center
- M.Tech. in Pharmaceutical & Fine Chemical Technology - Pharmaceutical & Fine Chemical Technology