Associate Director​/Assistant Director - Analytical R&D

Location: Bengaluru

Leadership role to manage team size of 20+ scientists (Ph.D. and M.Sc.)
Extensive knowledge in E&L
Planning and excution of projets in Analytical services
Extractable and Leachable experience in CCS as per USP monograph and medical devices as per ISO guidelines
Ensuring the compliance related to all the activities
Method development/Validation experience in LC-MSMS, GC-MSMS and ICPMS instrument
Preparation and Implementation of SOPs related to E& L,Stability studies, general laboratory processes and best guidance.
Good knowledge of 21 CFR part 11, Data Integrity principals, good documentation practices in cGMP lab
Monitor and management of day-to-day laboratory activities
Subject Matter Expert for guiding extractables and leachable studies, Stability studies, Nitrosamine studies, PSD, PXRD, HPLC, GC-MS/MS, LC-MS/MS, ICP-MS, IC, Dissolution, UV-Vis, etc., including designing the preparation of protocols and report
Extensive knowledge of preparation, reviewing and approval capability for standard operating procedure (SOP) and COA
Sound knowledge of structural elucidation and interpretation using analytical techniques such as NMR, IR, HPLC, GC, LC-MS etc.
Resolving the team conflicts and provide training to the team for development and empowers team members
Provide scientific and leadership direction to team members
Knowledge on LIMS
Supporting in setting up lab facility and instrument distribution
Good knowledge of laboratory safety and be a strong promoter of SHE activities in the lab.

Skills Required:

For M.Sc, 20-25 years of Analytical R&D/QC experience in CRO environment
Excellent technical, problem-solving, writing, influencing and communication skills
Strong leadership with excellent interpersonal skills, proven success of analytical projects and managing cross functional teams
Demonstrative communication skills and confident in conveying information to internal/ external customers
Skill for resolving the team conflicts and provide training to the team for development and empowers team members
Behavioral

Competencies:

Excellent oral / written communication skills and flexibility to work in a dynamic environment
Excellent in Knowledge sharing at all levels.
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Qualifications
M.Sc
-Analytical Chemistry/Organic Chemistry/General Chemistry/Industrial Chemistry