Senior Analyst 1, Quality Control Bioassay

Fujifilm•Holly Springs, NC

3d•Onsite

About The Position

The Senior Analyst 1, Quality Control Bioassay works with limited direction to execute 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 Bioassay Sr. Analyst 1 adheres to GMP compliant laboratory operations in accordance with regulatory guidelines. This role generates analytical results and identify laboratory exceptions, invalid assays, deviations, change controls and corrective and preventative actions (CAPAs). The Sr. Analyst 1, QC Bioassay is primarily responsible for executing routine analytical methods in support of manufacturing, supporting laboratory execution of analytical method transfers and validations, and training other QC Bioassay laboratory associates.

Requirements

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 minimal supervision
Ability to effectively communicate and function in a fast-paced, highly technical environment is essential to success
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 conduct investigations, writing deviations and CAPA’s
Superior technical writing and problem-solving skills required
Must be flexible to support 24/7 manufacturing facility

Nice To Haves

M.S. in Virology, Microbiology, Biology, Chemistry, Biochemistry, Biological Sciences, or related science field with 1+ years of experience
Experience with LIMS software

Responsibilities

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
Provides training for QC Bioassay lab associates
Supports laboratory execution of analytical method transfers and validations
Assists with authoring and reviewing SOPs and technical reports
Works cross functionally with other QC departments, Manufacturing, Process Science, and Quality Assurance stakeholders to achieve customer and FUJIFILM Diosynth Biotechnologies objectives
Performs other duties, as assigned