Scientist, Analytical R&d (2nd Shift Operations: Cleaning Verification)

Merck Merck · Pharma · NJ

Scientist role in Pharmaceutical Analytical Sciences focused on cleaning verification analysis, method development, and validation within cGMP manufacturing operations. Requires experience in analytical chemistry and GMP compliance, with a focus on second shift operations.

What you'd actually do

  1. Support execution of Good Manufacturing Practices (GMP) activities such cleaning verification, method development and method validation to support development of active pharmaceutical ingredients (APIs), pharmaceutical formulations, and manufacturing processes using both traditional and advanced analytical tools during second shift operations
  2. Document the execution, procedure, results, and conclusions of experiments in a detailed and organized manner following ALCOA+ principles.
  3. Troubleshoot any investigations associated with GMP testing through active collaboration with cross-functional project teams and/or Quality stakeholders and identify appropriate corrective and preventative actions.
  4. Perform data entry, data review, and author analytical reports or data summaries.
  5. Work collaboratively with internal stakeholders and partners such as Global Development Quality and Pharmaceutical Operations.

Skills

Required

  • Analytical Method Development
  • Collaborative Development
  • Data Entry
  • Deviation Investigations
  • GMP Compliance
  • Manufacturing Processes
  • Standard Operating Procedure (SOP) Writing
  • Troubleshooting
  • Excellent written and oral communication skills
  • Interpersonal skills
  • Work in a team environment with cross-functional interactions

Nice to have

  • Hands-on experience in GMP Operations
  • Advanced chromatographic separation science
  • Method development/method validation
  • Empower and lab investigations/deviations

What the JD emphasized

  • cGMP manufacturing operations
  • cleaning verification analysis
  • method development and method validation