Walk in Interviews For ADL & Bio-Pharma @ Pune

Role & responsibilities

Analytical Development Laboratory (ADL)

Position: Executive

Experience: 03-08 Years

Qualification: M.Pharm / M.Sc

Job/ Skill Set

• HPLC/GC/IC method development, Validation and Transfer for API, complex OSD, complex

generics products like long acting injectables, nasal sprays, peptide injections, peptide OSUs,

oncology and Topical products etc using various analytical technique.

• Expertly in peptide characterization.
• Expertly in clinically relevant dissolution method evelopment and establishing IVIVC/IVIVR.
• Closely working with CRO/CDMO/CTL to develop and validate analytical method using

various technique.

• Having exposure to regulated, Semi Regulated & India markets.
• Hands on experience of analytical instruments ike HPLC, GC, lon hromatography, Particle

size analyzer etc.

• Hands on experience on NG/G Tube, IVRT/IVPT, Solid State characterization, Impurity

characterization, API Sameness study.

• Well versed with USPVEP/BP/IP and various current regulatory guideÑnes (IGH/EMEA/FDA)

Hands on experience on Nitrosamine and Genotoxic impurities method development,

Validation and Transfers by LCMS/GCMS.

• Expertise in routine analysis and FnD Support, Comparative evaluation of methods with

alternative vendor methods versus existing primary vendor and regulatory impact analysis.

• Experience in Dissolution method development, Comparative dissolution, Multimedia

dissolution and statistical evaluation, its report preparation and interpretation of data.

• Hands on experience on Preparation of STPs for API, Excipients, KSM, Intermediate,

In-process and Formulation for all tests.

• Well versed with instrument Calibrations and GLP Practices.
• Understanding of ICH guidance and Regulatory expectations is much appreciated.

Contact Details:

Email : nitinsingh@torrentpharma.com, devalmodi@torrentpharma.com