QCA Analytical Scientist II, Team Lead

Description:

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. On occasion, collaborate with Quality Control in performing method transfers as well as with troubleshooting existing qualified/validated assays. Support PD'in evaluating product stability and monitoring degradation pathways. Generate Experimental Plans'imd Project Summary reports as needed. Serve as in-lab leader and help direct day-to-day test planning activities.

Requirements:

• Perform Protein Characterization, Routine Testing or In-Process Support testing as required including ELISA, SOS PAGE, IEF, HPLC, Western Blot, BCA, Capillary Electrophoresis, cell-based assays, spectrophotometric, spectrotluorometric and other pertinent biological and biochemical assays as they pertain to GLP and GMP standards in support of tech transfer and process development activities.

• Evaluate emerging techniques in protein characterization for the production of biotherapeutics and develop assay as required.

• Assist PC teammates in troubleshooting assay optimization difficulties.

• Direct day-to-day PC-related laboratory activities and ensure that experimental plans are being followed.

• Be responsible for data review and data collaboration for assay projects.

• Work collaboratively and communicate data with depa11ment head as well as other involved parties.

• Communicate directly with Scientist II counterparts for various Clients during the project on boarding and initiation stage.

• Act as SME for commonly performed analytical methods.

• Create and/or Review of technical reports such as SOPs, experimental plans, interim project status reports and summary reports.

• Be prepared to optimize and troublesh"ot new assays using sound scientific judgement with approval of department head.

• 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 the Development groups (Cell Culture, Protein Purification, and Bio-Conjugation) and the Quality/Regulatory and Manufacturing groups on assay, and process related matters.

• Must be able to manage multiple projects.

• Demonstrate high attention to detail and proven track record of organizational excellence.

• Demonstrate strong problem-solving skills.

• Strong oral and written communication skills.

• Train on and become familiarized with all pertinent analytical techniques.

Education and Experience:

• BS or MSc in Biological or Biochemical sciences, and 5+ years relevant laboratory experience in antibody/protein characterization or quality control - particularly in the areas of immunology, molecular and cell biology, and protein chemistry.

• 2+ years' experience in Technical Writing.

• Previous CRO/CDMO experience is a plus.

• Leadership skills