Ruth Frenkel work email
- Valid
- Valid
- Valid
Ruth Frenkel personal email
Ruth Frenkel phone numbers
Experienced Scientist with a demonstrated history of developing analytical methods for Biologics (mAbs, Fc-Fusion & pegylated proteins) and Gene Therapy (AAV) characterization and QC release methods . Skilled in Mass Spectrometry, Capillary Electrophoresis, Method Qualification & Validation, GMP, High-Performance Liquid Chromatography (HPLC), and CMC program management and analytical control strategy.
-
Senior Scientist - Gene TherapyBiogen Nov 2022 - Nov 2023Cambridge, Ma, Us•Analytical program lead for 3 gene therapy programs, ensuring method readiness for separations and biophysical characterization methods for AAV capsid purity and residual impurities.• Established cross-functional collaborations to enhance process efficiency and accelerate product development.• Implemented mass photometry and a cost-effective TEM quantitation model for AAV empty capsids, driving a 400% increase in sample testing capacity. -
Scientist Ii - Gene TherapyBiogen Feb 2021 - Nov 2022Cambridge, Ma, Us• Analytical program lead on a cross-functional CMC team for a Ph III AAV gene therapy program, managing method development and qualification to strengthen the analytical control strategy for impurity assessments.• Authored BLA Module 3 sections S.2.3 and S.2.4, and contributed to impurity characterization section, ensuring FDA compliance, and meeting submission timelines.• Designed and managed the execution of experiments internally and at external CRO and CDMO partners to generate robust analytical data to support OOS and OOT investigations, Drug Product development objectives, and manufacturing timelines.
-
Scientist I - Gene TherapyBiogen Jan 2020 - Feb 2021Cambridge, Ma, Us• Developed a QC-friendly platform approach for measuring AAV empty capsids in multiple serotypes, suitable for process characterization and release testing, enabling an end-to-end control strategy.• Led investigations and designed analytical studies to elucidate root cause of OOT assay results and implement effective mitigation strategies, leading to improvement in upstream processes.
-
Scientist I (Manager) - Protein ChemistryBiogen Feb 2016 - Jan 2020Cambridge, Ma, Us• Managed a team of 4 scientists and associates, resulting in streamlined chromatography and physicochemical method development, qualification, and method transfer processes for biologics.• Analytical program lead on cross-functional product development teams for early-stage complex biologics, including Fc-fusion and conjugated hemophilia therapies.• Led cross-functional initiative to streamline platform method qualification, resulting in 300% shorter timelines, faster on-boarding of in-licensed and R-to-D programs, and expedited method transfers to QC.
-
Senior Associate Scientist - Protein ChemistryBiogen Jul 2012 - Feb 2016Cambridge, Ma, Us• Developed release and characterization methods for early- and late-stage biologics programs including HPLC, UPLC, LC-MS/MS, and GC-MS based methods.• Qualified analytical methods used to monitor product quality attributes for in-process samples, drug substance, and drug product; supported analytical investigations for clinical and commercial stage programs, and authored SOPs and technical reports.
-
Associate Scientist Iii - Protein ChemistryBiogen Feb 2010 - Jun 2012Cambridge, Ma, Us• Characterized early and late-stage clinical candidates using LC-MS/MS methods for protein posttranslational modifications, N-glycan identification, sequence confirmation, disulfide connectivity, and structure-activity relationship studies.• Developed novel LC-MS/MS and GC-MS metabolomics approaches for characterizing raw materials and cell culture processes contributing to enhanced upstream process understanding and control.
-
Associate Scientist Ii - Protein ChemistryBiogen Mar 2007 - Feb 2010Cambridge, Ma, Us• Developed platform methods and optimized method qualification protocols for SEC, icIEF, CE-SDS, and N-glycans assays, leading to more consistent method qualifications and enhancing overall data quality and compliance.
-
Associate Scientist I - Protein ChemistryBiogen Jul 2004 - Mar 2007Cambridge, Ma, Us•Product quality and compendial testing for mAbs •Enhanced company-wide data integrity by establishing uniform nomenclature for N-glycans and standardized appearance color and clarity terminology, ensuring regulatory compliance and improved product quality. Engaged with key stakeholders in quality and regulatory to develop a change management plan for legacy commercial products.
Ruth Frenkel Skills
Ruth Frenkel Education Details
-
The College Of Liberal Arts And Sciences At Arizona State UniversityBiotechnology And Molecular Biology
Frequently Asked Questions about Ruth Frenkel
What is Ruth Frenkel's role at the current company?
Ruth Frenkel's current role is Analytical Chemist | Gene Therapy & Biologics | Phase-Appropriate Method Development & Qualification | Quality-by-Design | Lifecycle Management.
What is Ruth Frenkel's email address?
Ruth Frenkel's email address is fr****@****neu.edu
What is Ruth Frenkel's direct phone number?
Ruth Frenkel's direct phone number is +161791*****
What schools did Ruth Frenkel attend?
Ruth Frenkel attended The College Of Liberal Arts And Sciences At Arizona State University.
What skills is Ruth Frenkel known for?
Ruth Frenkel has skills like Assay Development, Protein Characterization, Analytical Chemistry, Program Management, Mass Spectrometry, High Performance Liquid Chromatography, Biotechnology, Pharmaceutical Industry, Gmp, Validation, Standard Operating Procedure, Liquid Chromatography Mass Spectrometry.
Free Chrome Extension
Find emails, phones & company data instantly
Aero Online
Your AI prospecting assistant
Select data to include:
0 records × $0.02 per record
Download 750 million emails and 100 million phone numbers
Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.
Start your free trial