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Position Summary
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.
Education and Experience
Minimum Degree Required: Bachelor of Science or Equivalent
Experience:
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)
Knowledge, Skills, and Ability (Minimum required to perform the essential functions of the position):
Under general direction prepares, executes and documents complex laboratory experiments per established company guidelines and SOPs.
Under general direction, 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.
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Lexington, MAU.S. Base Salary Range:
$111,800.00 - $175,670.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. 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.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Job Exempt
YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.