Job Description & Scope
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 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. If you're a fit, send your resume to . Please share only relevant profiles. Qualifications M.Sc -Analytical Chemistry/Organic Chemistry/General Chemistry/Industrial Chemistry Role: Research & Development - Other Industry Type: Software Product Department: Research & Development Employment Type: Full Time, Permanent Role Category: Research & Development - Other Education UG: Any Graduate PG: Any Postgraduate Key Skills Skills highlighted with ‘‘ are preferred keyskills crohplcqcnmrgc chemistrypsdmethod validationuvcssquality controlanalytical method developmentdissolutiondata integrityglpanalytical chemistrylablcmsanalytical method validationorganic chemistrymethod developmenthtml
