Job
Description
We are seeking an experienced and dynamic leader to manage a team of 10+ scientists (Ph.D. and M.Sc.) in our analytical R&D laboratory. This role requires extensive expertise in Extractables and Leachables (E&L) testing, method development, and strong leadership to drive scientific excellence and operational efficiency in a cGMP environment. Key Responsibilities Leadership role to manage a team size of 10+ scientists (Ph.D. and M.Sc.) . Extensive knowledge in E&L (Extractables and Leachables) . Expertise in Extractable and Leachable experience in CCS (Container Closure Systems) 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 instruments. Preparation and Implementation of SOPs related to E&L , general laboratory processes, and best guidance. Good knowledge of 21 CFR part 11, Data Integrity principles, good documentation practices in a cGMP lab . Monitor and management of day-to-day laboratory activities . Extensive knowledge of preparation, reviewing, and approval capability for Standard Operating Procedures (SOPs) and COAs . Sound knowledge of structural elucidation and interpretation using analytical techniques such as NMR, IR, HPLC, GC, LC-MS, etc. Resolving team conflicts and providing training to the team for development, empowering team members. Provide scientific and leadership direction to team members. Good knowledge of laboratory safety and be a strong promoter of SHE (Safety, Health, and Environment) activities in the lab. Skills Required For M.Sc. candidates, 16-18 years of Discovery Analytical R&D experience ; for PhD candidates, 14-16 years of experience in a CRO environment . Excellent technical, problem-solving, writing, influencing, and communication skills. Strong leadership with excellent interpersonal skills, proven success in analytical projects, and managing cross-functional teams. Demonstrative communication skills and confident in conveying information to internal/external customers. Skill for resolving team conflicts and providing training to the team for development, empowering team members. Behavioral Competencies Excellent oral/written communication skills and flexibility to work in a dynamic environment. Excellent in Knowledge sharing at all levels.
