Prativa Sharma
Associate Manager, Qc @Adverum Biotechnologies
Signup · Get unlimited contacts
WORK HISTORY
Associate Manager, Qc @Adverum Biotechnologies
Collaborate with CMO counterparts to review quality documents including sample plans,qualification plans, test methods, etc- Collaborate with supply chain team and CMO counterparts to coordinate shipment of thesamples manufactured at CMO to Adverum, various Contract testing, and storage locations toensure the required release testing are performed in a timely manner- Review test results, deviations, OOE, and OOS investigations generated by Adverum QC and theCMOs- Review executed test results generated by various Contract Testing Labs for various DrugProducts, Drug Substance and the intermediates- Generate Certificate of analysis for various Drug Products, Drug Substance and intermediates- Perform routine QC testing as needed- Serve as a QC subject matter expert on various methods including complex QC methods suchcell-based assays including Potency assays, TCID50 and BacPak- Plan, organize and direct the activities related to Drug Product release, characterization andStability testing to ensure timely completion of tasks- Lead the qualification, validation, and transfer of analytical methods for drug product, drugsubstance- Participate in continuous improvements of quality systems (procedures and systems) to improveorganization effectiveness, quality assurance compliance, and regulatory and other requirements(cGMP, ICH)- Assist in Quality Metric review processes, assess data for adverse trends, develop solutions andoversee implementation. Routine monitoring of control trends to ensure proactive action plans ifa trend is found- Provide technical review, stability data and trend analysis review, including statistical analysis- Coaching, mentoring, engagement and development of the team, including training of newemployees. Routinely met with a direct report to discuss feedback, development opportunitiesand general support for team members.
EDUCATION
Kathmandu University (KU)
Bachelor of technology, Biotechnology
Siddhartha Vanasthali Institute
High School
The University of Alabama in Huntsville
Master's degree, Biology/Biological Sciences, General
SKILLS
ABOUT PRATIVA SHARMA
Experienced Scientist with a demonstrated history of working in the pharmaceuticals industry. Skilled in developing and executing various Molecular and Cell based assays. Strong research professional with a Master\'s degree focused in Biology/Biological Sciences, General from University of Alabama in Huntsville.
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.