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Job Description

About the Role:

As a QC Analytical Scientist, you will support multiple Quality Control activities within the AQC department. Main responsibilities are to transfer and implement analytical methods. These methods include raw materials, which are used in a CGMP environment in Quality control. Specifically, they involve both analytical quality control methods (AQC) and Quality Control Microbiology methods (QCM).

How you will contribute:

• Guide special projects that require AQC attention/leadership.
• Improve analytical method development and validation of laboratory methodologies and instrumentation.
• Support investigations and manufacturing investigations requiring analytical method support.
• Support the installation, operational qualification (IOQ), maintenance and troubleshooting of instrumentation in the AQC group.
• Serve on project teams, which will require substantial interaction and communication with other group functions.
• Upgrading of analytical technologies within an established licensed technology platform.
• Support the execution and issue resolution (e.g., discrepancies) and completion approval of test plans/protocols
• Support troubleshooting of analytical methods and instruments and support laboratory investigations to provide scientific justification for Out of Specification (OOS), Out of Trend (OOT), and atypical result investigations
• Create laboratory investigations, deviations, CAPAs, and periodic reviews, and other documentation that requires advanced analytical knowledge.
• Ensure all laboratory equipment is maintained in a validated state and that all analytical methods transferred follow company and regulatory requirements.
• Responsible for protocol and report generation and other technical documents. This includes supporting raw material qualification for new products
• Manage and perform assay control and critical reagent qualifications, including monitoring and trending of method performance.
• Help analyze QC data using statistical tools to identify trends and set limits for results, including data transcription/entry
• Use sound scientific principles and statistical techniques and make recommendations.
• Responsible for deliverables to ensure timelines and milestones are met.
• Support scheduling of AQC and QCM testing (release, execution of protocols).
• May lead small teams to accomplish tasks.
• Ensure Right First Time (RFT) in the method introduction and instrument qualification process.

What you bring to Takeda:

• Bachelor's degree in biotechnology, Microbiology, Pharmacy, Chemistry or equivalent is ideal.
• Minimum of 1 year of analytical development or validation experience in Pharmaceutical, Biopharmaceutical or related manufacturing environment, or an advanced degree.
• Write technical documents and reports that meet company and regulatory requirements
• Knowledge of analytical methods and operations with emphasis in problem-solving.
• Knowledge about analytical method validation and critical reagent qualification.
• Intermediate statistical knowledge and experience with data analysis.
• Knowledge concerning cGMP, especially lab related topics such as method validation and unexpected results investigation.
• Basic knowledge about regulatory requirements concerning analytical instrumentation, test methods and licenses
• Substantial understanding concerning regulatory standards requirements e.g., CGMP, QSR, USP, 21CFR, ICH
• Complete tasks with minimal direction, demonstration of basic project management skills.
• Ability to multi‐task in a highly dynamic and diverse environment.
• Attention to detail, able to meet deadlines.

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:

• Normal office and laboratory environment.
• May need to work in controlled or clean room environments requiring special gowning.
• May work around chemicals such as alcohol, acids, and buffers that may require respiratory protection.
• Able to work more than 8 hours a day or 40 hours a work week.
• The overall physical exertion of this position requires light to medium work.

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.

#GMSGQ #ZR1 #LI-Onsite

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:

U.S. Base Salary Range:

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.

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Job Exempt