- Act as the QC representative for New Product Introduction (NPI) activities, supporting product meetings and cross-functional project teams.
- Plan and perform routine and non-routine analytical testing using techniques including HPLC, rCE-SDS, Sub-Visible Particles and Protein Concentration/Content testing.
- Manage NPI sample activities across the site, including creation and ownership of sample plans, SOPs and associated GMP documentation.
- Coordinate LIMS data for NPI activities and report, evaluate, trend and approve analytical data.
- Support laboratory investigations, troubleshooting, controlled document changes, audits and continuous improvement initiatives.
- Ensure all activities are performed in compliance with cGMP, Data Integrity requirements and applicable regulatory standards.
- Bachelor's degree in a Science discipline with 2-3 years of biopharmaceutical QC, Quality Control or GMP laboratory experience within the pharmaceutical industry.
- Strong hands-on analytical laboratory experience, ideally including HPLC, rCE-SDS, Sub-Visible Particles and/or Protein Concentration/Content testing.
- Strong knowledge of cGMP, Data Integrity and GMP documentation, with excellent technical writing, problem-solving and communication skills.
