Administration
 Ensuring Laboratory Safety as per OSHA regulations.
 Costing of projects, preparing annual budget and planning for timely and cost effective completion of the analytical development activities including allocation of resources and work among team members.
 Providing technical guidance to team members and coordinating with other departments (internal & external customers) on various aspects of development.
 Reviewing and monitoring the work periodically to ensure adherence to set timelines, plans, costs, cGLP, safety and regulatory requirements.

> M. Pharm with 10 to 16 yrs of experience.
> Ph.D. will be an added advantage.
> Extremely Good communication, interpersonal and leadership skills must.
> Person should have worked in a reputed & well established Pharma R&D
> Person should be Proactive with openness to analytical challenges.
> Capable to lead a team of 5-8 members and working on different projects for regulatory submission.

Instruments
 Proficient and working experience of Method Development & Method Validations using UPLC/HPLC
 Hands on experience of various analytical instruments viz. NMR, XRD, DSC, TGA, SEM, TEM, MS, FTIR, GC etc., preferred.
 Conducting reverse engineering of the marketed product to speed up development.
Regulatory
 Thorough knowledge of the requirements of ICH and CFR part 11 for establishing Stability Indicating analytical methods for intermediate drug product & finished drug product.
 Successful attendance of US FDA &/or EMEA audits by presenting the data related to Electronic backup of instrument data, Method Development and Analytical method validation will be an added advantage.
Stability Studies
 Should have handled Stability studies as per ICH and US FDA & EMEA norms.
 Prepared trend charts for stability profiles and impurity profiles
Qualification & Calibration
 Should have handled equipment installations and qualifications.
 Calibration of different analytical instruments like UPLC/HPLC & Dissolution apparatus etc.
 Validated Microsoft Excel calculation used for calculation of analytical results.
Documentation
 Prepared SOP’s, Specifications, GTP’s and STP’s for the analytical lab.
 Handled OOS investigation for stability studies.
 Establishing a fool proof mechanism for generation, archival and retrieval of electronic data.