Company Description

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

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 servicesExtractable and Leachable experience in CCS as per USP monograph and medical devices as per ISO guidelinesEnsuring the compliance related to all the activitiesMethod development/Validation experience in LC-MSMS, GC-MSMS and ICPMS instrumentPreparation 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 labMonitor and management of day-to-day laboratory activitiesSubject 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 reportExtensive knowledge of preparation, reviewing and approval capability for standard operating procedure (SOP) and COASound 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 membersProvide scientific and leadership direction to team membersKnowledge on LIMSSupporting in setting up lab facility and instrument distributionGood 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 environmentExcellent technical, problem-solving, writing, influencing and communication skillsStrong leadership with excellent interpersonal skills, proven success of analytical projects and managing cross functional teamsDemonstrative communication skills and confident in conveying information to internal/ external customersSkill 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 environmentExcellent in Knowledge sharing at all levels.

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Qualifications

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