SUMALATHA ANREDDY
Reference Standard program Lead at Purisys- Claim this Profile
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English Native or bilingual proficiency
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Telugu Native or bilingual proficiency
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Hindi Native or bilingual proficiency
Topline Score
Bio
Credentials
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C language programer
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Registered Pharmacist in India
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SAS Certified Base Programmer for SAS 9 (CBP)
Microsoft
Experience
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Purisys
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United States
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Reference Standard program Lead
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Jan 2023 - Present
• Co-ordinates management and routine analytical testing activities for the Reference Standards Program so to maintain a constant state of DEA (Drug Enforcement Administration) and cGMP (Good Manufacturing Practices) compliance. • Manages Research & Development Analytical Request database, logistics and material movement, documentation support, purchasing support, DEA coordinator duties, SAP (computer systems) support, and other duties as required by the Research & Development Department. • Interact with external and internal customers with regards to reference standards supply and qualification, material movement, and customer inquiries. • Oversee Program Operations to ensure timely analysis and release and other commitments are met. • Appropriately prioritize and delegate assignments and projects for self and team members. • Monitor and coach the performance of the team members. Assure program dedicated personnel are trained and qualified to perform job functions. • Reviews, summarizes, and releases analytical data and includes statistical packages. • Provides technical assessment of data and methodologies; analyzing and evaluating data and draws conclusions regarding material stability. • Interacts with affiliate companies and contract analytical laboratories to coordinate ongoing analytical testing for R&D department and reference Standard Program. • Serves as DEA coordinator for the R&D department. Identify, conduct, and lead opportunities to continuously improve quality, Cost, and efficiency of the processes. • Supports the program operations, tests, and analyzes materials, samples, and products to determine stability, purity, and chemical content etc. • Coordinates and oversights the Reference Standard Program which serves as a technical resource for Active pharmaceutical ingredients and chemical impurities of reference Standards. • Schedules and Co-ordinates the replenishment and qualification of the reference Standards. Show less
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AmbioPharm - A Global Peptide CDMO
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United States
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Pharmaceutical Manufacturing
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100 - 200 Employee
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QC Release Supervisor
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Sep 2021 - Jan 2023
• Reviews and Approves Final data for finished products, Crudes, and intermediate for QC data (Purity, Assay, Cleaning validation, Residual organic solvents, Qualification reports for reference Standards).• Provides QC reviewed data to QA within timeline.• Follow up with Release Finished product team for their daily tasks for execution and reviews.• Tests critical analysis when needed.• Performs Investigations and write ups for deviations, Out of specifications, Out of trends and CAPAs.• Helps release team in trouble shooting instrument issues and resolving daily challenges while testing.• Communicates in timely manner with QC Manager for updates. Show less
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QC Release Lead
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Jan 2019 - Sep 2021
• Final Approval and release of CV, raw materials, Crudes and Intermediate QC data.• Tested Critical Finished product and stability of Active Pharmaceutical ingredient for Purity, Assay by HPLC, UPLC (Waters – Empower 3.0) and %Water content by KF (Tiamo 2.2), ID by MS (Mass Lynx) and FTIR• Experienced in GC-HS for testing Residual Organic Solvents.• Followed up with quality team to execute daily tasks.• Updated Test methods, Specifications as per Customer request and FDA DMF deficiencies.• Performed reviews for validation, Change controls, Deviations, OOS, release testing and stability testing.• Created Purchase Orders for Release and Special testing for GMP and Non GMP materials.• Requested Quotes from Outside contract lab for validation and for regular testing.• Tested Bioassay for peptides.• Created sampling plan for special tests, GMP finished products and stability material.• Reporting initial to final stage updates to supervisor for finished product tests and change controls.• Follow up with fellow chemist for daily routine tasks and reporting Supervisor. Show less
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QC Chemist II
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Jan 2018 - Dec 2018
• Opening Change controls and Transferring methods from validation, customer documents and writing justification for it.• Experience in writing justification for DMF deficiency for FDA.• Working well in a cross functional team environment• Have proficient computer skills in Microsoft Word, Excel and Outlook.• Experience to read and execute methods from USP.• Experience in Creating sampling pan for APi finished product testing as well as stability tests.• Experience in writing Qualification reports for APi reference standards for commercial, NCE and Non GMP products.• Identify and solve problems with limited assistance.• Experience in writing and reviewing specifications, Test methods for stability, finished product and SOP, Lab notebook as necessary.• Experience in testing Amino acid analysis (AAA) using Agilent system and reviewing AAA data.• Skills in professional and technical writing and reviewing Standard operating procedures, standard test procedures, master batch records, final product and stability specifications.• Strong skills in reviewing finished product, stability, raw materials, crudes and intermediate data.• Experience in testing drug products and validation tests for precision, intermediate precision and linearity using HPLC, UPLC and KF.• Experience in testing raw materials, intermediate, crude and finished products and stability to analyze purity and Assay of the product.• Experience in Empower 3.0, Tiamo 2.2 software.• Performing Analytical Tests for GMP material using HPLC (Waters and Agilent), UPLC (Waters) and KF.• Maintaining QC lab standard orders for routine testing.• Experience in writing CAPA, Deviation reports and Out of Specification reports.• Supporting QC supervisor, QA in testing, reviewing and compiling data of finished product.• Responsible for finished product data, to send to QA after all Analytical tests done. Also responsible in sending Change control docs to QA, helping them in understanding it. Show less
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Q.C Chemist I
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Oct 2016 - Dec 2017
• Performing lab functions, and techniques to identify problems and support the completion of work assignments.• Peptide or protein manufacturing and purification by Crystallization, Chromatography and in process test methods outline. • Supervising in the transfer of relevant process procedures and technologies for routine utilization in the production of GMP material by following Standard operation procedures, standard test procedures.• Experience in writing SOPs, Test methods, Deviations, OOS and CAPAs and initiating document change requests. • Raw material sampling, testing them using HPLC, GC.• Performing and reviewing QC - stability, release, intermediate, Crude, cleaning verification tests.• Supporting routine analytical testing using GC, KF, and HPLC, UPLC, MS.• Experience in trouble shooting equipment for testing GMP material• Knowledge in Empower software.• Maintaining the QC lab by ordering standard supplies routinely used for testing.• Experience in testing raw materials, intermediate, crude and finished products to analyze purity and Assay of the product.• Performing method transfer and validation activities.• Supporting Quality assurance in reviewing Test methods, Tests, change controls etc. Show less
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PVR Technologies, Inc.
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King of Prussia, PA
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Clinical SAS Analyst
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Apr 2016 - Sep 2016
• Has clinical analyst experience, tested, analyzed and reported the clinical trial data by using various statistical procedures. • Performed, analysis of clinical trial data documentation and its validation process. • Involved in performing Quality Control in support of Clinical data analysis and final reporting • Experience in assisting statistical team in reviewing and preparing clinical data report. • Experience in Interpreting data, analyzing results using statistical techniques and providing ongoing reports. • Reviewing data specifications and preparing clinical summary reports. Show less
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Lamar University
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United States
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Higher Education
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700 & Above Employee
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Laboratory Student Assistant
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Oct 2014 - Dec 2015
• Created new laboratory processes and Organized Laboratory glassware and equipment. • Prepared chemical solutions used for lab classes that include reagents, acids, bases, stains and buffers. • Assisting with checkout of lab equipment to students and faculty. • Setting up the apparatus and assist in conducting classroom experiments and demonstration. • Keep records and effects the return of supplies and equipment checked out to students for laboratory use. • Using mathematical and scientific equations when appropriate for laboratory settings. • Trouble-shooting equipment for laboratory use. • Cleaning glassware, equipment, and the stockroom. • Cleaning and setting-up lab rooms. • Other laboratory duties were assigned depending on workload and laboratory needs. • Laboratory Housekeeping that involved maintain cleanliness in the laboratory and proper disposal of waste. Show less
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Dr. Reddy's Laboratories
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India
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Pharmaceutical Manufacturing
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700 & Above Employee
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Lab technician
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Feb 2012 - Apr 2013
• Employed chromatography, spectroscopy and spectrophotometry techniques. • Ability to learn the operation of laboratory equipment and instrumentation. • Instrumentation experience in HPLC, GC, IR, UV spectroscopy, TLC, DSC, TGA. • Working knowledge according to GMP, GLP guidelines. • Ability to learn and perform physical and instrumental analysis, as well as various wet chemistry techniques. • Evaluated and inspected incoming raw materials. • Conducted compounding and centrifugation operations. • Maintained up-to-date records of product technical data sheet and certificate of analysis. • Prepared chemical solutions and standards according to standard formulas. • Experience in Multi-step synthesis, Lab maintenance, Chemical reactions. • Responsible for the testing of lab samples (performance, stability, analytical, etc.) • Performed chemical and physical analyses on lab samples, raw samples and finished products. • Used wet chemistry techniques, stability studies pertaining to quality and quantity. Show less
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Education
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2014 - 2015
Lamar University
Master's degree, Chemistry -
2009 - 2013
Osmania University
Bachelor's degree, Pharmacy
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