Bioassay Scientist

Takeda • Lexington, MA

1d

About The Position

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 the development of methods supporting biological therapeutic product release and characterization in a compliance-based environment. He/she 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 SoftMax, GraphPad, 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.

Requirements

• 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)

Nice To Haves

• 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 SoftMax, GraphPad, 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.

Responsibilities

• Prepares, executes and documents complex laboratory experiments per established company guidelines and SOPs.
• Designs and implement scientifically sound and creative solutions to a variety of problems of moderate to complex scope
• Understands and applies advanced scientific principles, theories, concepts, practices and standards to method development
• Author and review technical documents such as protocols, reports, internal presentations
• Ability to manage externalized activities such as: method development, method qualification, method validation
• Ability and willingness to gain in-depth understanding of new technologies, method platforms, and scientific concepts.
• Experience automating plate-based potency methods.
• Experience with aseptic technique, tissue culture, and execution of potency methods, including cell-based, binding, and ELISA platforms.
• Effective communication skills, oral and written
• Proficient with standard computer applications
• Ability to work effectively both independently and in a collaborative environment with cross-functional partners.

Benefits

• U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
• U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level