Research Scientist II specializing in analytical method development, validation, and method transfer for solid oral dosage forms. Supports related substances, assay, dissolution, and in vitro study work while coordinating documentation, specifications, STPs, SOPs, and instrument upkeep. Partners with Formulation, QA, QC, Regulatory, and PMO teams to keep projects on timeline and audit-ready.
Hi, I’m
SANDEEP PATIL
Analytical Researcher II
Dombivli,Maharashtra
Summary
Overview
1
Language
19
years of professional experience
Work History
TEVA pharma Pvt. Ltd.
Research Scientist II
05.2011 - Current
Job overview
- Analytical method development and Validation of multi and single component for Related Substances method, Assay and Dissolution.
- Work for Invitro study and preparation for USFDA audits.
- Work for Reverse engineering of product.
- Worked cross-functionally with Formulation, Regulatory, Quality, PMO departments to facilitate project deliveries.
- Planning and execution of work for analytical activities for a given product to achieve project timelines.
- Execution of analytical method transfer.
- Ensure execution with compliance of analytical activities in the laboratory on time.
- Preparation and Review of method development, validation, method transfer and other analytical related documents.
- Troubleshooting of analytical issues.
- Preparation and finalization of specifications, STPs and SOPs.
- Operation, Maintenance and Calibration of analytical instruments/equipment'.
- Ambernath Maharashtra, India
ADL, Getz Pharma Pvt. Ltd.
Jr. Analyst
09.2009 - 05.2011
Job overview
- Analytical method development of multi and single component for Related Substances method, Assay and Dissolution for various pharmaceutical dosage forms.
- Troubleshooting of analytical issues/problems, handling queries related to product from market/regulatory authority.
- Ensuring Compliance to quality standard of cGMP also GLP.
- Operation & Calibration of analytical instruments/equipment's.
- Ambernath Maharashtra, India
Cipla Ltd.
Trainee Analyst
01.2008 - 12.2009
Job overview
- Analytical method development and analysis of routine samples (product development batches, stability study samples, etc.).
- Ensuring Compliance to quality standard of cGMP also GLP.
- Analysis of various dosage forms like Solid Orals & Injectables.
- Operation and Calibration of analytical instruments/equipment's
- Mumbai, India
Education
Somani College Under University of Mumbai
M. Sc.
10-2007
University Overview
K.V. Pendharkar College Under University of MumbaiMumbai
B. Sc.
03-2005
University Overview
Skills
Expertise in analytical method development, validation and In vitro release study
Experience on handling and characterization of Solid dosage forms
Polymorphic identification
Reverse engineering of product
Preparation and review of assessment report
Data-driven decision-making
Continuous improvements
Imparting training and teaching analytical skills to trainees
Analytical problem-solving
Environmental Health and safety compliance
Expertise in dissolution profile and impurities profile study
Fully participate in project execution from product introduction to exhibit/commercial batches
Knowledge of different regulatory bodies, providing analytical documents as per regulatory requirements and deficiencies management
Coordination and continuous communication with cross functional teams such as QA, QC and RA for timely delivery of projects
Actively participate in project meetings, familiar with ELN, Studium, Trackwise, Gloria
Review and finalization of Specification, STPs, SOPs, method development reports and method validation reports
Experience on new analytical laboratory set up with cGLP compliance
Hands-on experience of instruments such as HPLC, p-XRD, IC, UPLC, GC, IR, Dissolution apparatus, UV Visible spectrophotometer, etc
Interests
Hobbies:-Listening to Music, Playing cricket
Timeline
Research Scientist II
TEVA pharma Pvt. Ltd.
05.2011 - Current
Jr. Analyst
ADL, Getz Pharma Pvt. Ltd.
09.2009 - 05.2011
Trainee Analyst
Cipla Ltd.
01.2008 - 12.2009
Somani College Under University of Mumbai
M. Sc.
K.V. Pendharkar College Under University of Mumbai
B. Sc.