Bioassay Scientist

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The Bioassay Scientist will be responsible for designing and executing laboratory experiments to support the development, qualification, and automation of potency assays, including cell‑based methods. The group focuses on developing methods for biological therapeutic product release and characterization in a compliance‑based environment. The candidate must have experience with aseptic technique, tissue culture, multichannel pipetting, reagent preparation, method development and general laboratory upkeep.

• Experience performing potency assays, including cell‑based, binding, and ELISA platforms is required.
• Experience troubleshooting and optimizing cell‑based potency assays is desired.
• Experience overseeing outsourced analytical activities and collaborating with external partners is highly desirable.
• Familiarity with applicable regulatory guidelines (ICH, USP, EP), specifically as they pertain to potency assays is desired.
• Familiarity with software packages such as Soft Max, Graph Pad, PLA, and JMP is preferred but not required. Experience with automated liquid handling platforms such as the Hamilton Star or Vantage is desired.
• Familiarity with SPR, BLI, flow cytometry, and qPCR is desired.
• Experience developing stable analytical cell lines for reporter gene applications and/or elevated protein expression is desired.

Must have the ability to work in a collaborative team environment and communicate with cross‑functional partners effectively.

Minimum Degree

Required:

Bachelor of Science or equivalent.

• Ph.D. in Biology, Biochemistry or related discipline with 0–3 years of relevant postdoctoral or industry experience.
• MS in Biology, Biochemistry or related discipline with a minimum of 3 years relevant industry experience.
• BS in Biology, Biochemistry or related discipline with a minimum of 8 years relevant industry experience.
• In-depth understanding of relevant guidelines (ICH, USP 1032, 1033, 1034).
• In‑depth knowledge of theories/principles not limited to: performance of tissue culture, aseptic technique, potency methods (including cell‑based, binding, and ELISA platforms).

• Under general direction prepares, executes and documents complex laboratory experiments per established company guidelines and SOPs.
• Under general direction, designs and implements scientifically sound and creative solutions to problems of moderate to complex scope.
• Understands and applies advanced scientific principles, theories, concepts, practices and standards to method development.
• Authors and reviews technical documents such as protocols, reports, internal presentations.
• Manages externalized activities such as method development, method qualification, method validation.
• Is willing to gain in‑depth understanding of new technologies, method platforms, and scientific concepts.
• Automates plate‑based potency methods.