Analyst, QC Bioassay

The QC Analyst, Bioassay, with direction from manager, executes QC cell- and plate-based analytical methods including protein binding assays, cell-based potency assays, cell culture routine maintenance, and residual testing for DNA, Host Cell Protein (HCP), Protein A/G. The QC Analyst, Bioassay adheres to GMP compliant laboratory operations in accordance with regulatory guidelines. This role generates analytical results and identifies laboratory exceptions, invalid assays, deviations, change controls and corrective and preventative actions (CAPAs). The QC Analyst, Bioassay is primarily responsible for executing routine analytical methods in support of manufacturing, and as needed supporting laboratory execution of analytical method transfers and validations.

What You’ll Do

• Executes cell- and plate-based analytical methods including protein binding assays (e.g. ELISA, Dot Blot, etc.), cell-based potency assays, cell culture maintenance, and residual testing for DNA, Host Cell Protein (HCP), Protein A/G.
• Ensures analytical testing of in process, drug substance (DS), drug product (DP) and stability samples are performed according to appropriate GMP regulations.
• Ensures analytical testing data is captured in LIMS software and data integrity is maintained.
• Reports assay performance and assists with implementing improvements that ensure quality and efficiency within QC Bioassay Identifies and follows-up on excursions and deviations and initiate corrective and preventative actions (CAPAs).
• Coordinates and supports QC Bioassay lab activities, as needed.
• Supports laboratory execution of analytical method transfers and validations Assists with authoring and reviewing QC SOPs.
• Works cross functionally with other QC departments, Manufacturing, Process Science, and Quality Assurance stakeholders to achieve customer and FUJIFILM Biotechnologies objectives.
• Performs other duties, as assigned.

Knowledge, Skills, and Abilities

• Ability to effectively communicate and function in a fast-paced, highly technical environment is essential to success.
• Knowledge and experience growing and maintaining mammalian cell lines.
• Knowledge of cGMPs, ICH, USP, EP, JP and FDA requirements as it relates to Bioassay analytical methods. Working knowledge and experience in Microsoft Office products (Outlook, Word, Excel, and Power Point). Ability to work with moderate supervision.
• Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships. Excellent verbal and written communication skills and attention to detail.
• Thorough understanding of pharmaceutical/biotech testing.
• Proven ability to assist with conducting investigations, writing deviations and CAPAs.
• Basic technical writing and problem-solving skills required.
• Must be flexible to support 24/7 manufacturing facility.

Minimum Qualifications

• Bachelor’s degree in life sciences, Virology, Biology, Chemistry, Biochemistry or related science field with 0-1 years of experience.
• Basic understanding of GMP, GLP, GDP requirements.
• Experience with cellular and molecular analytical testing methods.
• Experience performing QC testing involving cell culture, PCR, ELISA, Dot Blots, etc.