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If you believe you have been contacted by an unauthorized person, please contact your local law enforcement agency immediately.
QC Analytical Scientist (Method Introduction & Site Support)
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a QC Analytical Scientist in our Thousand Oaks, CA office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do.
We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
The Quality Control (QC) department at Takeda Thousand Oaks is looking for a motivated QC Validation Scientist to join the Method Introduction and Service (MI&S) Team. This role will lead the transfer and validation of new test methods as well as lifecycle management of existing methods and instruments for GMP lot release of biologic and cell therapy products.
Essential Duties and Responsibilities
- This role will be responsible to drive analytical method validation of laboratory methodologies and instrumentation, the ideal candidate will have a background in method validation and will be familiar with GMP manufacturing requirements.
- Ensure all laboratory equipment is maintained in a validated state and that all analytical methods transferred are in compliance with company and regulatory requirements. This role will be responsible for lifecycle management and new instrument qualification for a variety of analytical instruments, including HPLCs, PCR, plate readers, container closure testers and rapid microbial detection technology, for new and existing products within the quality control laboratory at Takeda, Thousand Oaks
- The role will be responsible for protocol and report generation as well as authoring CMC submission and other technical documents as required.
- Supports local QC process monitoring and process improvement through application of descriptive statistics and visualization and statistical process control using out-of-the-box-tools
- Support development of best demonstrated validation practices within the QC validation department, based on current industry practices and guidelines
- 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 as needed to provide scientific justification for initial Out of Specification (iOOS), Out of Trend (OOT), and atypical result investigations
- Upgrading of analytical technologies within an established licensed technology platform
- Manage and perform assay control and critical reagent qualifications, including monitoring and trending of method performance.
- Support the analysis of QC data using statistical tools to identify trends and set limits for results, including data transcription/entry
- Use sound scientific principles and statistical techniques to solve problems and make recommendations.
- Lead small teams as needed to accomplish tasks.
- Ensure Right First Time (RFT) in the method introduction and instrument qualification process
- Complete all tasks in a timely and appropriate manner.
- Support continuous improvement activities.
- The applicant must have excellent technical writing skills and be able to write generate technical documents and reports that meet company and regulatory requirements
- In depth knowledge of analytical methods and operations with strong emphasis in problem-solving.
- Knowledge about analytical method validation and critical reagent qualification.
- Experience in problem solving (facilitation and application of tools)
- Intermediate statistical knowledge and experience with data analysis.
- Knowledge of Statistical Process Control and ANOVA
- 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
- Has substantial knowledge and understanding in terms of regulatory standards requirements e.g. cGMP, QSR, USP, 21CFR, ICH etc.
- Ability to 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
- Good organization and time management skills to meet deadlines.
- Proficient in Microsoft Office.
- Strategically and business-oriented thinking
- Fluent in English
Education and/or experience
- Bachelor’s Degree in biotechnology, Microbiology, Pharmacy or equivalent
- At least 3 years of analytical development or validation experience in Pharmaceutical, Biopharmaceutical or related manufacturing environment, or an advanced degree.
- The overall physical exertion of this position is sedentary work.
- Normal office environment.
- Position requires frequent usage of a personal computer
- May be required to work or be assigned to a different shift as needed.
- Must be able to work more than 8 hours a day or 40 hours a workweek as required.
- May be required to travel for business reasons, e.g. training and meetings.
- May need to work in controlled or clean room environments requiring special gowning. May be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body. No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in these work environments.
- May be exposed to dust, gases, and fumes.
- Possible exposure to cool/hot storage conditions.
- May be around moving equipment and machinery.
- May be working in a loud area that requires hearing protection and other protective equipment to be worn.
- May work around chemicals such as alcohol, acids, and buffers that may require respiratory protection.
- Inside working conditions.
- Will interact with other people (cross functional).
- Pace may be fast and job completion demands may be high.
- This job posting excludes CO applicants.
EEO Verbiage for US Reqs
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.