QCA Analytical Scientist II, Team Lead

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Under limited supervision, oversee execution of and review data analysis for client product tech transfers and assay verifications for the Protein Characterization team. Provide analytical support testing, as needed, to Upstream Processing, Downstream Processing, and Bioconjugation groups. Collaborate with Quality Control to perform method transfers and troubleshoot existing qualified/validated assays. Support PD in evaluating product stability and monitoring degradation pathways. Generate experimental plans and project summary reports as needed.

Serve as in‑lab leader and help direct day‑to‑day test planning activities.

• Perform Protein Characterization, Routine Testing or In‑Process Support testing, including ELISA, SOS PAGE, IEF, HPLC, Western Blot, BCA, Capillary Electrophoresis, cell‑based assays, spectrophotometric, and spectrofluorometric assays under GLP and GMP standards.
• Evaluate emerging techniques in protein characterization for biotherapeutics and develop assays as required.
• Assist PC teammates in troubleshooting assay optimization difficulties.
• Direct day‑to‑day PC‑related laboratory activities and ensure experimental plans are followed.
• Be responsible for data review and collaboration for assay projects.
• Work collaboratively and communicate data with department heads and other involved parties.
• Communicate directly with Scientist II counterparts for various clients during project onboarding and initiation.
• Act as SME for commonly performed analytical methods.
• Create and review technical reports such as SOPs, experimental plans, interim project status reports, and summary reports.
• Be prepared to optimize and troubleshoot new assays using sound scientific judgment with department head approval.
• Assist in onboarding and document creation for new instrumentation in the PD Lab.
• Perform PD Lab inventory checks; create and manage purchase order requests for new projects.
• Record laboratory activities and results in appropriate notebooks.
• Assist Quality Control group in troubleshooting assays, where appropriate.
• Effectively interact and assist other groups within Development (Cell Culture, Protein Purification, Bio‑Conjugation) and Quality/Regulatory and Manufacturing on assay and process‑related matters.
• Manage multiple concurrent projects.
• Demonstrate strong attention to detail and organizational excellence.
• Demonstrate strong problem‑solving skills and effective oral and written communication.
• Train on and become familiar with all pertinent analytical techniques.

• BS or MSc in Biological or Biochemical sciences, and 5+ years of relevant laboratory experience in antibody/protein characterization or quality control—particularly in immunology, molecular and cell biology, and protein chemistry.
• 2+ years of experience in technical writing.
• Previous CRO/CDMO experience is a plus.
• Leadership skills.

• Mid‑Senior level

• Full‑time

• Research, Analyst, and Information Technology