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 10+ scientists (Ph.D. and M.Sc.)
Extensive knowledge in E&L
Extractable and Leachable experience in CCS as per USP monograph and medical devices as per ISO guidelines
Managing multiple instruments (LC-MSMS, GC-MSMS, ICP-MS, IC etc.)
Method development experience in LC-MSMS, GC-MSMS and ICPMS instrument
Preparation and Implementation of SOP’s related to E& L , 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
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
Good knowledge of laboratory safety and be a strong promoter of SHE activities in the lab.
Skills Required:
For M.Sc, 16-18 years of Discovery Analytical R&D experience and for PhD, 14-16 years of 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
Manager/Group Leader- E&L