Shreya Sathe
Bloomington,IN
Summary
Highly talented individual with expertise in vaccines and biologic's and seeking full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills.
Overview
6
6
years of professional experience
1
1
Certification
Work History
QC Scientist
Catalent Pharma Solutions
09.2021 - Current
- Provide support for lab safety and safe use and storage of chemicals in compliance to regulatory rules.
- Performing Routine testing on parenteral product such as Particulate Matter, physical test, total acidity.
- Performing Client specific test for in process and finished products such as total acidity needle length, delivery volume and specialized identification tests.
- Conducting Monthly Reference Standards Audits and concluding observations and providing inputs for continuous improvement and periodic requalification of Reference Standards provided by the Client testing for cGMP use.
- Measuring impact assessment for the QC lab and providing technical support for continuous improvement.
- Trained new employees on areas of technical expertise and compliance issues relevant to lab setting.
- Working with development and tech services team to deliver goals related to product release.
- Performing routine testing by using HPLC (Reverse Phase, SEC, IEX, polysorbates, Glycans,Lipids, Assay & Degradations, ID testing) along with performing complex troubleshooting and assist with solving scientific problems with assays.
- Experience with Electronic Notebooks (ELN).
- Assisting and reviewing the batch record calculations or related documents.
- Writing Laboratory Events and Investigating the Root Cause
- Owner of Change Controls for Methods that are needed to be effective for cGMP use.
- Updating and Revising Analytical Methods and SOP
- Managing several clients related projects simultaneously.
- Ability to work Independently under minimum supervision and work collaboratively in team.
- Acting as a Client Representative to work on Client based projects (Method Feasibility and Method Transfer).
- Review of technical documents and assist laboratory with turnaround goals.
QC Chemist
InvaGen Pharmaceuticals
06.2021 - 08.2021
- Daily calibrations of equipments (Analytical Balances, pH, Osmometer) and documented readings and adjustments to improve equipment accuracy.
- Performed standard and proprietary physical testing and chemical analysis of raw chemical materials and finished products.
- Advised training interns and laboratory technicians on existing and emerging quality control methods to enhance testing and research capabilities.
- Developed Empower (HPLC) reports based on testing observations.
- Cleaned and organized laboratory-keeping the lab Audit ready.
- Performed standardized tests on organic and inorganic compounds to observe fundamental differences in properties.
- Calibration and troubleshooting of Laboratory instruments
- Modify and authorize Standard Operating Procedure (SOP) and Analytical Methods(AM) for cGMP use.
- Assisted with Technical Transfer and Method Transfer as per standards and specifications.
QC Intern
InvaGen Pharmaceuticals
01.2021 - 05.2021
- Hands on experience in testing of finished products for organoleptic properties, moisture content by KF and identification by FTIR, UV spectrophotometry, HPLC
- Performing other physical test on oral tablets and capsules.
- Documenting incoming finished and stability products in Laboratory Information Management system (LIMS)software.
- Preparing Buffers and Lab solutions and performing Dissolution Test on tablets and capsules along with time points profiling using Dissolution autosampler.
- Reporting data in the Lab notebook as per GDP.
- Investigating OOS and OOT observations under the supervision of the QC Manager and preparing reports for the same.
- Documenting Product Specifications Release Report in Log Notebooks and assisting in SOP updates and modifications.
- Revising and following the SOPs as per the cGMP requirements.
- Prepared project presentations and reports to assist senior staff.
- Generated reports detailing findings and recommendations.
Chemistry Lab Assistant
New Jersey Institute Of Technology, NJIT
02.2020 - 11.2020
- Prepared lab for experiments using chemistry knowledge and instructional information.
- Created and updated record of all supplies and equipment to monitor inventory.
- Organized instructional materials, facilities and solutions for experiments.
- Restocked laboratory areas and sterilized surfaces to maintain readiness or experiments.
- Assisted Professors with conducting lab experiments for undergraduate students. (Remote Laboratory)
- Grading examination papers and assignments for undergraduate students.
- Proctoring Examinations (Online and Offline) for University Examinations
Technical Intern
VAB Pharma Private Limited
12.2018 - 06.2019
- Shadowed personnel to learn appropriate methods for solving customer issues and troubleshooting technical problems.
- Providing strategic advice to management for the entire drug development cycle.
- Providing aid in presenting registration documents to maintain marketing authorization for the product.
- To ensure that the pharmaceutical processes are complying with the regulations.
- Helping the company to maintain Good Documentation Practices(GDP).
- Worked with vendors to resolve problems with services, equipment, or inventory.
Summer Intern
Johnson & Johnson
05.2017 - 07.2017
- Completed research, compiled data, updated spreadsheets, and produced timely reports.
- Participated in workshops and presentations related to projects to gain knowledge.
- Sorted and organized files, spreadsheets, and reports.
- Interacted with customers by phone, email, or in-person to provide information.
- Explored new technologies and approaches to streamline processes.
- Opened, sorted and distributed incoming mail and packages.
Education
Master of Science - Medicinal And Pharmaceutical Chemistry
New Jersey Institute of Technology
Newark, NJ05.2021
Bachelor of Science - Pharmacy
MET Institute - College of Pharmacy
Mumbai, India06.2018
Skills
HPLC
Excellent Communication and Verbal Skills
mRNA handling, LNP (lipid Nanoparticles), Human Enzymes, Biologics, Vaccines
Subject Matter Expert (SME) for various standardize assays and specifications
Software: Empower 3 FR5 , Lab Solutions, Tiamo -Karl Fischer, LIMS V8, MES, Trackwise
Updating SOP's Owner and Authoring documents, Deviations and Laboratory Investigations, Change Controls,
Root Cause Analysis ; 5M, 5 Why's, Is /Is Not, Fishbone
White Belt- Six Sigma
Accomplishments
- Awarded the “Bayer Organic Award” with respect to holding excellent academic positions during the undergraduate course study.
- Treasurer, Secretary at MET - Selected for outstanding ability and interest in art - ran meetings, five gallery shows, art community service, and coordinated the field trips.
- Secured first prize for a Poster Presented on applications of pharmacokinetics at the One-day seminar on “Biopharmaceutics and Pharmacokinetics: Bench to Bedside” at MET Institute of Pharmacy.
- Presented a poster on “Management of lifestyle diseases”, in Annual Pharma Conference, INSIGHT2016 – Healthcare: prism of opportunities organized by Indian Education society
Certification
- Licensed Pharmacist - Council of Pharmacist (India)- 2018-2035
Languages
English
Full Professional
Hindi
Full Professional
Marathi
Native or Bilingual
french
Professional Working
Timeline
QC Scientist
Catalent Pharma Solutions
09.2021 - Current
QC Chemist
InvaGen Pharmaceuticals
06.2021 - 08.2021
QC Intern
InvaGen Pharmaceuticals
01.2021 - 05.2021
Chemistry Lab Assistant
New Jersey Institute Of Technology, NJIT
02.2020 - 11.2020
Technical Intern
VAB Pharma Private Limited
12.2018 - 06.2019
Summer Intern
Johnson & Johnson
05.2017 - 07.2017
Master of Science - Medicinal And Pharmaceutical Chemistry
New Jersey Institute of Technology
Bachelor of Science - Pharmacy
MET Institute - College of Pharmacy
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