Engineer II, Process Development

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Job Description
Objective / Purpose:
The individual will be a member within a group responsible for performing upstream and downstream related process development activities, including timely completion of small-scale experiments, scale-up, technology transfer and GMP floor support for programs that bring new biopharmaceutical products to pre-clinical, clinical and process validation manufacturing phases. Under supervision, the scope of work includes cell banking, cell expansion, bioreactor process, harvest clarification, chromatography, filtration process development activities, including optimization, characterization, scale-up, and technology transfer to CMO's and/or internal manufacturing facilities. The individual applies basic knowledge from various technical areas, industry standards and practices, provides quality and productive output that is consistently timely, reliable and reproducible.
Accountabilities:

• Works with departmental and/or cross functional peers to execute on assignments, under limited supervision.
• Prepares experimental protocols.
• Contributes significantly to project work which may include multiple projects within functional area.
• Interprets data independently, and contributes to technical reports.
• Identifies complex technical issues related to cell culture and protein purification process development, and implements solutions under supervision.
• Contributes to the design of new applications/experiments/unit operations in consultation with supervisor.
• Supports technology transfer through writing and consolidating technical documents.
• Coordinates within department as well as cross functionally with peers on projects.
• Maintains laboratory facilities in accordance with procedure.
• Present issues and discusses results in group and team settings as needed.
• Apply fundamental engineering and/or biological principles to practical technical challenges

Education & Competencies (Technical and Behavioral):

• Associate degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science and 2+ years relevant industry experience
• Bachelor's degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science and some relevant experience
• Previous experience working in biologics laboratory or GMP manufacturing environment.
• Experience in equipment maintenance.
• Experience following written or standard operating procedures/work practices.
• Experience using certain documentation practices for data capture (batch records and/or laboratory notebooks).
• Excellent communication skills, both oral and written.
• Ability to learn new techniques, and perform multiple tasks simultaneously.
• Knowledge or prior experience with aseptic technique, solution chemistry, and laboratory equipment operation (i.e. bench-top bioreactors, AKTA Systems with UNICORN software, normal and tangential flow filtration and depth filtration).
• Experience in preparation of cell culture medium and solution.
• Experience in preparation of necessary materials (buffers, packed columns).

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, MA
U.S. Base Salary Range:
$70,000.00 - $110,000.00
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.
Locations
Lexington, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Job Exempt
Yes
It 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.