Description

Scope of Function: 

Under limited supervision, execute and provide data analysis of Client product tech transfers and assay verifications for the Analytical team. Provide analytical support testing, as needed, to GMP manufacturing, Upstream Processing, Downstream Processing and Bioconjugation groups. On occasion, collaborate with QC in performing method transfers as well as with troubleshooting existing qualified/validated assays. Support QC/PC in evaluating product stability and monitoring degradation pathways. Generate Experimental Plans and Project Summary reports as needed.

Specific Duties:

· Perform Protein Characterization, Routine Testing or In-Process Support testing as required including ELISA, SDS PAGE, IEF, HPLC, Western Blot, BCA, Capillary Electrophoresis, cell-based assays, spectrophotometric, spectrofluorometric 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.

· Work collaboratively and communicate data with department head as well as other involved parties.

· 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 troubleshoot new assays using sound scientific judgement with approval of department head.

· Assist in on-boarding and document creation for new instrumentation in the Analytical Lab.

· Perform Analytical 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.

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

Requirements

Education and  Experience:

 · BS or MSc in Biological or Biochemical sciences, and 3-5 years relevant laboratory experience in antibody/protein characterization or quality control – particularly in the areas of immunology, molecular and cell biology, and protein chemistry.

 · Previous CRO/CDMO experience is a plus.