Renu Goel
Director | Analytical Methods Development | Biopharmaceuticals | Drug Substance & Product Characterization | Leadership | Mentoring | Quality Control | Mass Spectrometry| Biologics| ADC| CDMO
- Role
- Associate Director of Analytical Development at Abzena
- Location
- Philadelphia, PA, US
- LinkedIn followers
- 500 followers
About Renu Goel
As the Director of Analytical Development and Mass-Spectrometry at CuriRx and…
Experience
Associate Director of Analytical Development
Sep 2024 — Present · Bristol, PA, US
Leads and manages technical team within analytical method development (AMD) GMP and non-GMP for ADC’s, oligonucleotide with drug payloads to meet deadlines for phase-appropriate project deliverables ensuring client expectations are met.• Leads method development and pre-qualification efforts within the AMD team to support process development, product pre-formulation studies, in-process monitoring, drug substance and drug product testing.• Leads method pre-qualification and method transfer for applicable team methods to the quality• control laboratory.• Reviews analytical test methods, qualification/validations, protocols/reports, and stability protocol/reports.• Oversees and troubleshoots methods run within analytical team.• Provides data interpretation and statistical analysis.• Serves as a leadership and mentoring model for AMD team members.• Communicates effectively with clients, supervisors, colleagues, and staff.• Develops individual AMD employee goals.• Operates to the highest ethical and moral standards.• Complies with Abzena\'s policies and procedures.• Participates effectively as a team player in all aspects of Abzena\'s business.• Adheres to quality standards set by regulations and Abzena policies, procedures, and mission.
Education
IASE Deemed University
Master's degree, Biotechnology
2004 — 2006
Kuvempu University, Shankaraghatta, Shimoga
Doctor of Philosophy - PhD
Skills
- Data Analysis
- Molecular Biology
- Pcr
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