Associate Director/Assistant Director - Analytical R&D

Job description:

• Leadership role to manage team size of 20+ scientists (Ph.D. and M.Sc.)
• Extensive knowledge in E&L  
• Planning and exécution 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 SOP’s 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.

If you're a fit, send your resume to Sekhar.Sompalli@advinus.eurofinsasia.com. Please share only relevant profiles.