Position Overview

The Quality Control Analytical technologies (QCAT) group is seeking a dynamic Senior Scientist to manage the team-based execution of assay protocol driven activities for client programs. The QCAT group is a technologically diverse group that primarily performs formal Tech Transfer, Qualification, Validation and Verification of test methods coming out of the development group and then transitions them into our Quality Control group. This high performing group is the interface between the development and quality groups and is responsible for ensuring long term success of the methods entering into QC.

The successful candidate will focus on creating analytical method protocols and summary reports (TT, qualification, validation and verification). The role will oversee individuals executing protocols, review data, ensure a seamless transition to the QC group in a manner that sets them up for right first time and prolonged execution success, troubleshoot issues/spearhead investigations, and work closely with the QA group and client SMEs throughout. The candidate will also be expected to follow cGMP documentation practices and initiate deviations, lab investigations, method revisions and other related activities within the quality system.

Company Overview

The work we do at FUJIFILM Diosynth Biotechnologies has never been more importantand we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in peoples lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy, and drive - what FUJIFILM Diosynth Biotechnologies call Genki.

College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.

Job Description

Essential Functions:

• Desirable candidate will have a strong QC mindset and bringing Quality-by-Design concept (QbD) into analytical activities to ensure robust methods entering the QC space.
• Project management expertise for analytical activities (planning, timeline creation, team management, effective escalation, drive for success and on-time completion of activities)
• Technical expertise in several of the following fields with focus on Chemistry, specifically in the analysis of proteins: H/UPLC (Empower), electrophoresis - reduced/non-reduced CE, spectroscopy, SoloVPE, plate-based assays (SoftMax Pro), Molecular assays (qPCR, ddPCR), SoloVPE. Additionally, desirable to have expertise in microbiology (bioburden, endotoxin), and Compendials including appearance, pH, osmolality. As a senior scientist, you must have demonstrated problem solving capabilities for standard biopharmaceutical laboratory techniques.
• Designing, managing, and executing protocols for the Qualification, Validation, Verification or assay Tech Transfer of recombinant biopharmaceutical protein analytical methods. Late-stage method validation experience is also highly desired.
• Managing a team of scientists in a direct or matrix environment with an eye towards team development with high performing scientists.
• Regulated GMP experience, with knowledge of ICH guidelines for methods, positive working relationships with Quality groups and experience with opening, executing and closing protocol events, investigati ns and change controls within Trackwise. Regulatory audit experience is a plus.

Required Skills and Abilities:

• Must have the cell culture experience and bioassay design experience.
• Strong mentorship skills.
• Excellent work ethic with a strong emphasis on data integrity.
• Strong oral and written communication skills.
• Demonstrated ability to engage with clients.
• The optimal candidate will have a keen eye for detail, excellent writing skills, and desire to engage in a positive manner with clients.
• Continuous improvement initiatives (initiating and completing).
• Excellent interpersonal skills, the ability to work individually or as part of a team; a person who highly values collaboration.
• Comfortable multi-tasking in a fast-paced environment with defined deliverables and deadlines.