Sanket Shah
Charlottetown,Prince Edward Island
Summary
Experienced and resourceful Analytical Development Research Scientist with over 11 years of research experience in analytical method development, validation/verification, method transfer, troubleshooting and documentation in various leading R&D and CDMO. Strong leadership qualities of managing projects and personnel as well as training teams in research procedures and mentoring for achievement Proven skills in HPLC, UPLC, GC, Dissolution, ICP-OES, ICPMS, LCMS, Zetasizer, XRD, MALS, DSC, TGA, KF, UV-VIS, AFM, FT-IR, CZE, CAD, ELSD, Ribogreen Assay Highly experienced in handling OOT and OOS investigations, statistical data analysis, CTD documents for ANDA filing, preparing responses to FDA deficiencies. Familiar with various regulatory compliance guidelines, such as cGMP, GxP, US FDA, ICH, MHRA, ISO and TGA Demonstrated ability to work on multiple projects, overall laboratory functions in GMP environment, managing project activities in relation to availability of resources and timelines.
Overview
11
11
years of professional experience
Work History
Analytical Research Scientist
Complex Injectable/LNP, BioVectra INC
08.2019 - Current
- Developed and Validated stability indicative analytical methods for assay, RS, dissolution, residual solvent, LC-MS and XRD for raw material and finished products using various analytical techniques
- Analysis of in process and stability samples at predefined schedule of various dosage form
- Planning and execution of experiments as per DOE at various process step in collaboration with other departments to identify CPP and CMA
- Planned and Organized laboratory personnel, equipment and resources based on priorities, expertise, and timelines
- Played active role in deciding specification limits for various analytical methods inline with ICH and FDA guidelines
- Monitoring and review of trend plots, stability data and implementing continuous improvement plans during product life cycle management
- Continuously utilized expertise and chromatographic knowledge to trouble shoot issues relating to peak identification, resolution, dissolution, and XRD troubleshooting
- Preparation and review of method development report, validation report, justification report and protocol for drug analysis – assay, impurities, residual solvents, dissolution, chromatographic Purity and chiral analysis in line with ICH and FDA guideline
- Worked closely with quality and regulatory affairs to meet project technical document requirements that led to successful product submission
- Drafted and revised laboratory Standard Operating Procedures, RDWI, QCTPD
- Preparation of AQBD (Quality by Design) report for various products to identify CQA and defining strategies to mitigate risk
- Mentored and supervised junior scientist in development and troubleshooting various technical issues
- Frequently made presentations on technical issues, solutions, and new technology trends in group meetings
- Collaborated with clients, formulators, procurement, and quality team for successful and timely completion of projects
- Provided feedback on laboratory budget needs and lab associate development needs
- Recommended areas of training or literature that would enhance needed skill or information.
Senior Research Executive
Sun Pharma Advanced Research Centre, SPARC
02.2013 - 08.2019
- Developed, Validated, and transferred analytical methods for assay, RS, dissolution and ICP for various dosage forms and formulations – complex and sterile injectables, tablets, capsules, lyophilized powder, gels, creams, suspension with different analytical techniques
- Developed and validated analytical method for elemental impurities for different formulations using ICP MS
- Developed and validated analytical method for OVI for different formulations using GC
- Responded to FDA query by developing method for determination of Critical micelle concentration (CMC) determination for injectable formulation, Ultrafiltration method for determination of low molecular weight iron complexes
- Responded to FDA deficiency by developing the Polarographic method for determination of ferrous impurity in complex injectable formulation, Complex viscosity and rheological properties determination for ophthalmic gel, Dissolution method development for lyophilized product
- Performing admixture studies, photo-stability studies, compatibility studies and technology transfer
- Calibration and maintenance of various analytical instruments
- Preparation of quality analytical deviation report including root cause analysis, CAPA and risk assessment
- Authored white papers, reviewed technical documents, laboratory notebooks and data packets per cGMP, ICH, and good documentation guidelines
- Resolved conflicts between personnel on laboratory technical understanding, procedures, and priorities
- Served as Subject Matter Expert in responding FDA question and in internal audits
- Proposed use of vapor safe HPLC waste container, acid dispensing pipettes, special potent compound handling procedures and waste management and disposal strategies to enhance safety in laboratory.
QA QC officer
Troikaa Pharmaceuticals limited
04.2012 - 02.2013
- Perform regular audits of dispensing, production, and packaging area throughout every shift
- Monitoring testing procedures to ensure that all test are performed according to established item specification, standard test method or protocols
- Investigate or report questionable test result
- Identify quality problems and purpose solutions
- Participate in internal and external audits as required
- Review of BMR and BPR
- Issuance of controlled documents, change control, equipment logbooks and inventory forms
- Participate in OOT and OOS investigations and recommend corrective actions.
Education
Masters (MS) - Pharmaceutical Analysis
04.2012
Bachleor - Pharmacy
04.2012
Skills
- Proficient in various chromatographic data system and software
- Empower 3
- Rheocalc
- QTEGRA
- LIMS
- Minitab
- Tiamo,
- Syspro
- Unipoint
- Mastersizer 3000
- Miniflex
- 32 Karat
- Astra7
- WinSOTAXpluS
- Calibry
- Minitab
- Design Expert
- ACD labs
- Effective in written and oral communication
- Analytical Method Development and validation
- Method transfer
- Problem Solving and Troubleshooting
- Lean Six Sigma, Experimental Designs, DOE, FMEA
- Equipments IQ, OQ, PQ
- Audits, Data Integrity and lab Compliance
- Investigations, Deviations, Root Cause Analysis, CAPA, Risk Assessment
- GMP documentation, Protocol and report writing and review
- SOP Writing/Editing/Revision and Implementation
- Control Sample Management, document issuance and control
- Team Leadership and Collaboration
- Extensive Organization Skills, Time Management and Critical Thinking
- Skilled Technical Mentor
- Effective written and oral communication
- Handling of client presentations, project expectations and deliverables
Timeline
Analytical Research Scientist - Complex Injectable/LNP, BioVectra INC
08.2019 - Current
Senior Research Executive - Sun Pharma Advanced Research Centre, SPARC
02.2013 - 08.2019
QA QC officer - Troikaa Pharmaceuticals limited
04.2012 - 02.2013
Gujarat Forensic Science University - Masters (MS), Pharmaceutical Analysis
Gujarat University - Bachleor, Pharmacy
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