Manager/Group Leader- E&L

16 - 18 years

4 - 6 Lacs

bengaluru karnataka india

Posted:2 days ago| Platform: Foundit logo

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Skills Required

project management data analysis process improvement team leadership risk assessment quality control

Work Mode

On-site

Job Type

Full Time

Job Description

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.

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