QC Analytical Scientist

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Job Description

Job Title: QC Analytical Scientist

Location: Thousand Oaks, CA

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 build analytical methods, including raw materials, for use in a CGMP environment in Quality control, both analytical quality control methods (AQC) and Quality Control Microbiology methods (QCM).

How you will contribute:

• Guide special projects that require AQC attention/leadership.
• Guide analytical method development and validation of laboratory methodologies and instrumentation. This includes leading analytical/microbiology QC efforts to help introduce new product testing, modifying existing laboratory space, plan design new laboratory spaces and working with vendors to purchase new instruments, and the installation and qualification of new instruments.
• 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, in a leadership role, which will require substantial interaction and communication with other group functions.
• Upgrade 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 initial Out of Specification (iOOS), Out of Trend (OOT), and atypical result investigations.
• Review 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 authoring CMC submission and other technical documents. This includes supporting raw material qualification for new products.
• Manage and perform assay control and important 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).
• Lead small teams to accomplish tasks.
• Representative for Analytical projects with global and local site functions. Ensure Right First Time (RFT) in the method introduction and instrument qualification process.
• Excellent technical writing skills and able to write create technical documents and reports that meet company and regulatory requirements.
• In-depth knowledge of analytical methods and operations
• Knowledge about analytical method validation and important reagent qualification.
• Intermediate 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 knowledge regarding regulatory standards requirements e.g., CGMP, QSR, USP, 21CFR, ICH

What you bring to Takeda:

• Bachelor's Degree in biotechnology, Microbiology, Pharmacy, Chemistry or equivalent.
• At least 3 years of analytical development or validation experience in Pharmaceutical, Biopharmaceutical or related manufacturing environment, or an advanced degree.
• Background and knowledge concerning cell-based assays.

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision
• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
• Health & Wellness programs including onsite flu shots and health screenings
• Generous time off for vacation and the option to purchase additional vacation days
• Community Outreach Programs and company match of charitable contributions
• Family Planning Support
• Professional training opportunities
• Tuition reimbursement

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:

• The physical exertion of we ask that you have light to medium work.
• Normal office and laboratory environment.
• 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 around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• Work more than 8 hours a day or 40 hours a work week.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and the best patient support programs. Takeda is a patient-focused company to 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.

Base Salary Range: $64,400.00 - $92,000.00. Employees may also be eligible for Short-term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days and Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.

The final salary offered for this position may take into account many factors including location, skills, education, and experience

This posting excludes Colorado applicants.

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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 - Thousand Oaks - Rancho Conejo

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time