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Senior Scientist/Tech Lead

2 months ago

Durham North Carolina, United States Fujifilm Full time
About the Role

We are seeking a highly skilled and experienced Senior Scientist/Tech Lead to join our team at Fujifilm Diosynth Biotechnologies. As a key member of our Analytical Development group, you will be responsible for managing the team-based execution of assay establishment and qualification activities for client programs.

Key Responsibilities
  • Evaluate client methods to ensure adherence to Fujifilm best practices
  • Identify equipment or procedural gaps and generate qualification protocols
  • Manage qualification execution and generate qualification summary reports
  • Oversee individuals executing protocols, review data, and ensure a seamless transition to the QC group
  • Troubleshoot issues, spearhead investigations, and work closely with the QA group and client SMEs
  • Follow cGMP documentation practices and initiate deviations, lab investigations, method revisions, and other related activities within the quality system
Requirements
  • PhD and 1+ year experience, MS and 6+ years' experience, or BS and 10+ years' experience in the biopharmaceutical industry
  • Project management expertise for analytical activities, including planning, timeline creation, team management, effective escalation, and drive for success
  • Technical expertise in several fields, including the analysis of proteins, plate-based assays, mass spectrometry, H/UPLC, and electrophoresis
  • Designing, managing, and executing protocols for the qualification of recombinant biopharmaceutical protein analytical methods
  • Managing a team of scientists in a direct or matrix environment with an eye towards team development
  • Regulated GMP experience, knowledge of ICH guidelines for methods, and positive working relationships with Quality groups
  • Strong oral and written communication skills, with experience working in a contract manufacturing or testing organization
  • Continuous improvement initiatives, excellent interpersonal skills, and the ability to work individually or as part of a team
About Fujifilm Diosynth Biotechnologies

Fujifilm Diosynth Biotechnologies is a leading contract development and manufacturing organization (CDMO) that provides a comprehensive range of services to support the development and manufacture of biopharmaceuticals. We are committed to delivering high-quality products and services to our clients, while also fostering a culture of innovation and collaboration.