Neelam Suthar
Kendall Park,NJ
Summary
Energetic and responsible pharmaceutical professional with experience working in FDA and cGMP regulated pharmaceutical industry. Well organized, easily trainable, quick learner and self-motivated individual with excellent verbal and written communication skills. Personable Quality Analyst with excellent computer system quality analysis experience. Talented at interpreting complex data, analyzing test procedure improvements and investigating product and service failures. Skilled critical thinker with expansive mathematical abilities.
Overview
11
11
years of professional experience
Work History
QC Analyst
JANSSEN PHARMACEUTICALS
08.2022 - Current
- Performed high complexity testing by preparing samples for analysis and maintaining assay quality.
- Prioritized work assigned, maintained accurate records of work performed and initiated corrective action in case of defective records or inadequate care plans.
- Provided technical guidance and training to laboratory staff.
- Investigated and resolved issues related to laboratory processes and procedures.
- Recorded and interpreted laboratory results to present to senior colleagues.
- Adhered to laboratory safety procedures to maintain compliance with quality control standards.
- Participated in lab meetings and project presentations.
- Troubleshot and resolved equipment and process issues.
- Coordinated and managed laboratory projects and experiments.
- Provided support and guidance to junior lab staff.
- Trained and supervised junior technicians in laboratory protocols.
- Analyzed results using analytical software and created reports.
- Comply with all regulatory/in house requirements (cGMP, cGLP, GDP)
- Involved in data review.
Analyst- Contract
JANSSEN PHARMACEUTICALS- KELLY SERVICES
07.2019 - 05.2021
- Performed analytical testing on stability samples
- Independently planned and executed testing to meet established timelines
- Recorded data and results as specified in documentation procedures in LIMs and in notebooks following GDP
- Complied with all regulatory/in house requirements (cGMP, cGLP, GDP)
- Communicated Out of Specification and Out of Alert Limit results.
Chemist/Metrologist
AUROLIFE PHARMACEUTICALS, NJ
10.2018 - 07.2019
- Performed physical and chemical tests on raw materials, for release using various wet chemicals, physical and instrumental techniques (HPLC, UV-Vis, IR, KF auto titrator, Bulk Density and other routine QC instruments) using USP, in-house test methods and other compendia monographs
- Independently planned and made adequate inventory of test reagents, and solutions to perform work, assure supplies are ordered as needed to perform assigned work
- Daily calibration of pH meter and analytical balances
- Calibration of HPLC
- Independently planned and executed testing to meet established timelines
- Recorded data and results as specified in documentation procedures in LIMs and in notebooks following GDP
- Complied with all regulatory/in house requirements (cGMP, cGLP, GDP)
- Review Test Procedures, SOPs and Protocols as assigned.
Scientist 1
AMNEAL PHARMACEUTICALS, NJ
07.2017 - 08.2018
- Performed analytical testing on stability samples of marketed products, raw materials, In Process and Finished Products for release using USP and in-house test methods
- Provided analytical support to process validation and analytical development group
- Communicated and involved in investigation of Out of Specification and Out of Alert Limit results
- Daily calibration of pH meter and analytical balances
- Executed online documentation and good documentation practices for each activity
- Prepared swabs for cleaning validation and performed analysis of the same.
Research Scientist-Contract
INNOVERA PHARMACEUTICALS INC.LLC, NJ
03.2017 - 07.2017
- Designed experimental plans, performed pre-formulation studies, formulation development work and optimized formulation and process
- Involved in development of product/raw material specifications including evaluation of physicochemical properties and compatibility of raw materials
- Reviewed analytical data to support product development
- Performed reverse engineering on innovator products and designed similar generic product by formula optimization
- Performed analytical testing of formulated R and D batches and associated stability studies on the same using HPLC and other analytical techniques
- Wrote protocols and batch records/lab notebook to carry out process development and evaluation work.
- Streamlined research processes to meet tight deadlines for multiple projects.
- Documented and reported test results after making graphical solutions and representations.
Clinical Pharmacist
Ministry Of Health
04.2013 - 12.2016
Education
No Degree - Advanced Drug Safety And Phamacovigilance
Sollers College
New Jersey10.2019
Masters in Pharmaceutics -
Manipal University
India01.2012
Bachelor of Pharmacy -
Manipal University
India01.2010
Skills
- Well versed with cGMP and GDP Knowledge of FDA, ICH guidelines, ALCOA practice
- Expertise on extensive scientific literature search, critical data analysis and report creation
- Problem Resolution
- SOP Development
- Training Implementation
- Correction Action Planning
- Safety Requirements
- Operational Procedures
- Pharmaceutical Development
- LabWare LIMS
Timeline
QC Analyst
JANSSEN PHARMACEUTICALS
08.2022 - Current
Analyst- Contract
JANSSEN PHARMACEUTICALS- KELLY SERVICES
07.2019 - 05.2021
Chemist/Metrologist
AUROLIFE PHARMACEUTICALS, NJ
10.2018 - 07.2019
Scientist 1
AMNEAL PHARMACEUTICALS, NJ
07.2017 - 08.2018
Research Scientist-Contract
INNOVERA PHARMACEUTICALS INC.LLC, NJ
03.2017 - 07.2017
Clinical Pharmacist
Ministry Of Health
04.2013 - 12.2016
No Degree - Advanced Drug Safety And Phamacovigilance
Sollers College
Masters in Pharmaceutics -
Manipal University
Bachelor of Pharmacy -
Manipal University
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