Associate Director/Assistant Director - Analytical R&D

Eurofins Advinus is a premier preclinical and early development CRO offering drug discovery, preclinical and development stage contract research services in the areas of discovery services, regulatory Toxicology (Safety Assessment), DMPK, Analytical R&D Services and API CDMO. Eurofins Advinus manufactures drug substances to support Toxicology and early clinical studies.

With over 30 years of GLP compliance and certification, Eurofins Advinus serves diverse industries such as Biotech, Pharmaceutical, Biological, Agrochemical, Nutraceutical and Cosmetic. Eurofins Advinus is the only contract research organization (CRO) in India to have developed data in support of 90+ end-to-end IND enabling packages to be submitted to global regulators such as USFDA, EMA, MHRA, Health Canada and others.

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 [email protected]. Please share only relevant profiles.

M.Sc - Analytical Chemistry /Organic Chemistry/General Chemistry/Industrial Chemistry