Nayan R. Bhalodiya
Ahmedabad
Summary
Dynamic analytical professional with extensive experience at Amneal Pharmaceuticals, excelling in method development and validation. Proven expertise in HPLC and regulatory compliance, complemented by strong problem-solving and team leadership skills. Successfully led projects in OSD and inhalation dosage forms, ensuring adherence to stringent quality standards and regulatory guidelines.
Overview
25
25
years of professional experience
Work History
Assistant Manager, ADL (US)
Amneal Pharmaceuticals
Ahmedabad
01.2023 - Current
- Review of MDI and DPI products (i.e. Inhalation products) method development, release, stability, method validation/verification/equivalencies/transfers and other related raw data/COA/reports and drug characterization data.
- Prepared and reviewed analytical method development reports, stability summary reports, draft methods, control methods, change control documents, SOPs, OOS and OOAL reports, conclusion reports, audit trail annexures, justification reports, and investigation reports to ensure compliance and accuracy.
- Review of analytical raw data / reports / COA for sample analysis, verification/validation studies and other analysis / studies related to OSD, Extractable Leachable and Inhalation dosage forms by various instruments like HPLC, GC, LC-MS, GC-MS, HR-MS, ICP-MS, ICP-OES as well as by other instrument techniques if any.
- To review electronic records and audit trails of Empower and non-Empower software used in respective instruments.
- Performed data integrity audits and random compliance audits in laboratory to uphold regulatory standards and ensure data reliability.
- Managed ARD documents archival room and performed activities for compliance with the SOP.
- Coordinated regulatory audits, internal audits, and other audits while responding to related queries to facilitate compliance and address concerns.
Sr. Research Associate - Assistant Manager, ADL (US)
Amneal Pharmaceuticals
Ahmedabad
02.2015 - 03.2022
- Analytical method development, stability, method validation and routine analytical activities for OSD projects by sophisticated instruments like HPLC, GC, LCMS, GCMS, UPLC, ICP-MS, particle size analyzer, XRF, XRPD and UV etc.
- Working on a projects of OSD (IR,DR,ER, Capsules, Tablets, and Pellets) study of dissolution profiling, assay, force degradation, solubility, related substances, related compound, particle size analysis, water content, content uniformity and blend uniformity etc. by various methods and instruments like Dissolution apparatus (USP,I,II,III,IV), UV, HPLC (Waters, Shimadzu) etc.
- Analytical method development, stability, method validation, scale up support, DPC activity and routine analytical activities for MDI DPI Dosage forms by sophisticated instruments like NGI, ADSA, PSD, DUSA, Spray View and HPLC etc.
- Working on a projects of Inhalation (MDI and DPI) by various tests like APSD by ACI & NGI, DDU, drug content, related compounds, particulate matter, spray pattern and plum geometry etc.
- Experience of Extractable and Leachable studies are also carried out for method development, stability and method validation.
Research Associate, ADL (Europe)
Zydus Cadila Healthcare
Ahmedabad
06.2011 - 02.2015
- Analytical method development and Validation for OSD projects by HPLC, UPLC and UV.
- Preparation and review of test procedure, development reports, method validation protocol and LNBs.
- Preparation and review of SOPs, STPs, and regulatory submissions.
Analytical Scientific Officer, ADL (US)
Zydus Cadila Healthcare
Ahmedabad
03.2007 - 04.2009
- Analysis of raw materials, finished products, and stability testing.
- Method development and validation for Dissolution, Assay & RS.
- Hands-on with HPLC (Waters, Shimadzu, Agilent), UPLC, RRLC.
- Dissolution profiling, impurity profiling, and degradation studies.
Q.C. Officer
Sparsh Bio Tech
Jamnagar
06.2006 - 02.2007
- Analysis of raw materials, finished products, and stability testing.
Analytical Chemist
Reliance Petrochemicals
Jamnagar
04.2004 - 09.2004
- Analysis of raw materials and finished products testing.
Project Trainee
Tata Chemicals & Ambuja Cement
10.2001 - 04.2002
- Three month training in both companies.
Education
Ph.D. - Natural Product Chemistry (Phytochemistry)
G.A.U
JamnagarM.Sc. - Analytical and Pharmaceutical Chemistry
Saurashtra University
RajkotDiploma - Chemical Eng.
Govt. Polytechnic
RajkotB.Sc. - Chemistry
D.K.V. Science College
JamnagarHSC -
GSEB
GandhinagarSkills
- 15 years of pharmaceutical industry experience with Zydus Cadila and Amneal Pharmaceuticals
- Proficient in method development, validation, documentation, and regulatory compliance
- Hands-on experience with HPLC, HPTLC, UV, IR, XRPD, XRF DSC, TGA, Particle Size Analyzer and Dissolution for Solid Oral Dosage (OSD)
- Hands-on experience with ACI, NGI, ADSA, DUSA, Spray View, Spray Tech, MDI ACS, Microscope (Particulate Matter) and Dissolution for Inhalation (MDI-DPI, Inhalation)
- Expertise in dosage forms: tablets, capsules, ointments, suspensions, sachets, Inhalation and natural products
- Familiar with SOPs, GLP, cGMP, NDA/ANDA data, and regulatory guidelines (ICH, OECD)
- Strong analytical and problem-solving skills; team leadership experience
Accomplishments
- Awards in Drawing, Elocution, and Management Tests.
- Consistently met project deadlines with dedication and integrity.
Audits Faced
Successfully prepared documentation and participated in audits by: FDA, WHO-GENEVA, MHRA
Research Publications
More than 18 + research papers published in National and International journals.
Father's Name
Rameshbhai R. Bhalodiya
Personal Information
- Date of Birth: 20/05/1982
- Gender: Male
- Nationality: Indian
Languages
- Hindi
- Gujarati
- English
Research Special Projects
- Led NG tube studies for US projects; developed and validated methods for in-vitro comparison.
- Coordinated team of 10-15 people from method development to CMC activity and submission.
Fields Of Interest
- Analytical Chemistry
- Medicinal Chemistry
- Spectroscopy & Chromatography
- Natural Product Chemistry
Hobbies and Interests
- Cricket
- Music
- Reading
Training
- Chromatography and Stereochemistry - Saurashtra University, Rajkot
- Nanotechnology - Saurashtra University, Rajkot
- Regulatory Affairs in Pharma Industry - Saurashtra University, Rajkot
Disclaimer
I hereby declare that the information provided is true to the best of my knowledge and belief. I am committed to contributing my best to your esteemed organization.
Timeline
Assistant Manager, ADL (US)
Amneal Pharmaceuticals
01.2023 - Current
Sr. Research Associate - Assistant Manager, ADL (US)
Amneal Pharmaceuticals
02.2015 - 03.2022
Research Associate, ADL (Europe)
Zydus Cadila Healthcare
06.2011 - 02.2015
Analytical Scientific Officer, ADL (US)
Zydus Cadila Healthcare
03.2007 - 04.2009
Q.C. Officer
Sparsh Bio Tech
06.2006 - 02.2007
Analytical Chemist
Reliance Petrochemicals
04.2004 - 09.2004
Project Trainee
Tata Chemicals & Ambuja Cement
10.2001 - 04.2002
Ph.D. - Natural Product Chemistry (Phytochemistry)
G.A.U
M.Sc. - Analytical and Pharmaceutical Chemistry
Saurashtra University
Diploma - Chemical Eng.
Govt. Polytechnic
B.Sc. - Chemistry
D.K.V. Science College
HSC -
GSEB