Manager/Group Leader- E&L

Key Responsibilities

• Lead and manage a scientific team of 10+ scientists (Ph.D. and M.Sc.), overseeing their performance, development, and scientific output.
• Provide technical and scientific direction in Extractables and Leachables (E&L) studies for Container Closure Systems (CCS) as per USP guidelines and medical devices as per ISO standards.
• Oversee and manage advanced analytical instrumentation including LC-MS/MS, GC-MS/MS, ICP-MS, IC.
• Lead method development and validation on LC-MS/MS, GC-MS/MS, and ICP-MS platforms.
• Prepare, implement, and ensure compliance with SOPs related to E&L, laboratory workflows, and regulatory guidelines.
• Ensure adherence to 21 CFR Part 11, data integrity principles, cGMP, and good documentation practices.
• Supervise daily lab operations, ensuring efficiency, quality, and compliance.
• Review and approve SOPs, COAs, and scientific documentation in line with regulatory expectations.
• Provide expert-level structural elucidation and interpretation using analytical techniques like NMR, IR, HPLC, GC, LC-MS.
• Act as a conflict resolver and mentor, fostering a positive and empowering work environment.
• Promote a culture of safety (SHE) in the laboratory through training, compliance, and proactive initiatives.
• Serve as a scientific liaison for internal and external stakeholders, presenting data and project progress confidently.