Scientist, Biopharmaceutical Development, Cell-Based Assay

About this Opportunity

In this role you will support the daily operations of the Biopharmaceutical Development Department by performing assigned large molecule, often cell-based assay, method development, validation and characterization studies in accordance with cGMP requirements, company policies and procedures as directed by laboratory management.

Responsibilities:

• Perform method feasibility, development, verification, transfer, qualification, validation and/or characterization testing of biopharmaceutical raw materials, intermediates, API, and/or drug product samples in accordance with cGMP requirements, company policies and procedures as directed by laboratory management.
• Read and understand test methodologies, study protocols, and Standard Operating Procedures in order to review or execute testing in compliance with necessary policies and procedures. Record/review data in controlled notebooks, data sheets, and electronic systems (i.e. LIMS, etc.) in accordance with cGMP requirements.
• Work on routine tasks where analysis of situations or data requires review and evaluation of limited factors, limited judgment is required in resolving problems and making routine recommendations. Exercise judgment within defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
• Notify Supervisor of any discrepancy in laboratory testing or general laboratory operations. In case of any observed discrepancies, initiate and follow through with the required quality exception documentation as needed.
• Assume ownership of assigned quality documentation, such as exceptions, change controls, and CAPAs, ensuring that documentation is initiated and closed on time, required actions are thorough and meet procedural requirements as well as customer needs.
• Recommend equipment, facility and process improvements to your supervisor.
• Maintain clear, accurate and traceable documentation records to ensure compliance with Good Documentation Practices (GDP).

Qualifications - Experience and Education:

• Bachelor's degree in Biochemistry or equivalent in scientific discipline required. Advanced degree preferred.
• A minimum of 4 to 6+ years cGMP pharma work experience required.
• Experience with of cell-based assay development, protein and peptide chemistry, binding assays, and tissue culture using techniques such as ELISA and gel electrophoresis.

The starting annual salary range for this position is based on job level: Associate Scientist starting range: $70,000 - $77,000 and Scientist starting range: $80,000 - 90,000.