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Job Description
About the role:
Plan, develop improvement and compliance projects relating to assay method validation/remediation, and Analytical Instrument Qualification. Responsible for basic project management and documentation authoring (e.g. protocols and reports). Provide technical expertise investigation teams in troubleshooting/problem solving activities as applicable. Provide recommendations for decisions of test systems and results of moderate complexity. Self-led individual that works toward goals.
How you will contribute:

• Lead ongoing assay validation/remediation activities for Biochemistry and Microbiology Laboratory, guiding personnel and ensuring smooth operation across all shifts.
• Develop test procedures, protocols, reports, and documentation to support method and equipment validation and revisions.
• Guide Analytical Instrument Lifecycle projects including qualification, relocation, decommissioning, and risk assessments.
• Manage quality processes for change controls, deviations, and CAPAs, ensuring compliance and resolution.
• Author complex technical assessments to support investigations and problem-solving initiatives.
• Develop systems focusing on assay performance indicators, including trend analysis and data analytics.
• Lead process and product improvement projects through CAPA, QWT, and other methodologies, from data generation to report preparation.
• Support laboratory audit readiness efforts, ensuring compliance with FDA, Takeda, and other regulatory requirements.

What you bring to Takeda:

• Typically requires bachelors' degree in science, engineering, or other related technical field. Bachelor's Degree in Chemistry or Biological Science. 2 years of related experienced. Leadership experience.

Important Considerations
At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. You may:

• In general, your work will be a combination of sedentary work, standing work, and walking around observing conditions in the facility.
• Must be able to lift, push, pull and carry up to 25 lbs.
• 20/20 near vision required (corrected as acceptable).
• Must be able to recognize and distinguish among the colors red, yellow, and blue.
• May work in a confined area.
• Some Clean Room and cool/hot storage conditions.
• May work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Will need to remove all make-up, jewelry, contact lenses, nail polish and artificial fingernails while in the manufacturing environment.
• May work in a cold, hot or wet environment.
• May work multiple shifts, including weekends, or be asked to work supplemental hours.
• May work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• Inside working conditions.
• 5% travel as applicable.

More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
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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:
USA - CA - Los Angeles
U.S. Base Salary Range:
$84,000.00 - $132,000.00
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 e mployee s may be eligible for s hort - t erm and/ or l ong- t erm incentive s . 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
USA - CA - Los Angeles
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.