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　　Job Description

　　About the role:

　　Plan, develop, evaluate improvement and compliance projects relating to lab instrument and assay method validation and remediation. Responsible for basic project management and documentation authoring (e.g. protocols, reports, lab procedures). Provide technical knowledge and support investigation teams in troubleshooting activities as applicable. Support recommendations for decisions of test systems and results of moderate complexity. Self-led individual that works under only very general supervision to meet goals.

　　How you will contribute:

　　Co-lead ongoing lab instrument or assay remediation activities across all shifts for the Biochemistry and Microbiology Laboratory including guiding assigned personnel in instrument and assay performance., also assist other Quality areas in the successful performance of these activities.

　　Develop or revise lab procedures and generate protocols, reports and other documentation to support instrument and method revisions and validation.

　　Lead or co-lead Analytical Instrument Lifecycle projects including qualification, relocation, decommissioning, risk assessments, and periodic reviews.

　　Manage quality processes, investigations, and actions for change controls, deviation events, and CAPAs

　　Develop systems that focus on main indicators of assay performance including laboratory control trends and data mining.

　　Be directly involved in and lead multiple process/product improvement projects. These projects may be performed through CAPA, QWT, Kaizen, or other locus groups, design of experiments, studies, data generation and analysis, report preparation, presentations, and change control.

　　Assist in laboratory audit ready status efforts in understanding FDA, Takeda, and other regulatory and quality requirements. Maintain a level of expertise in current regulatory requirements and serve as a laboratory resource for compliance to these requirements.

　　Co-lead in the development of customer awareness and support activities for Biochemistry and assist and drive such activities throughout the shifts.

　　Operational liaison with multiple customers including Manufacturing, Quality Assurance and Process Development, and Technical Services.

　　Interface with other Takeda sites for development, improvement, and understanding of analytical methods, instruments, and technology.

　　Review methods and SOPs. Write memos, reports, protocols, capital justification, and other documentation as they pertain to lab operations and procedures.

　　Drive Lean principles such as 5S throughout daily work activities.

　　May perform removal of hazardous waste.

　　What you bring to Takeda:

　　Qualifications

　　Understanding of critical laboratory, manufacturing and facility processes

　　Understand scientific strategies and be able to recommend different technical strategies and analyses during investigations.

　　Perform advanced data analysis through multiple applications software.

　　Represent the laboratory through technical presentations and presentations.

　　Can understand and apply cGMP/GDP, follow methods/SOPs, and meet EHS requirements.

　　General knowledge of statistical techniques. Working knowledge of CFR, USP, and other applicable compendia.

　　Proficient with wide variety lab application software.

　　Education and/or experience

　　Typically requires bachelors' degree in science, engineering, or other related technical field. Bachelor's Degree in Chemistry or Biological Science.Physical Demand

　　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.

　　In general, you will have a combination of sedentary work, standing work, and walking around observing conditions in the facility.

　　Work Environment

　　Will work in controlled environments requiring special gowning. Will follow gowning requirements and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.

　　No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.

　　May work in a cold, wet environment.

　　May work in a confined area.

　　Some Clean Room and cool/hot storage conditions.

　　Will work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

　　Will work supplemental hours to complete work commitments.

　　Inside working conditions.

　　5% travel as applicable.

　　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 and development 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:

　　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.

　　Need to remove all make-up, jewelry, contact lenses, nail polish and artificial fingernails while in the manufacturing environment.

　　Work in a cold, wet environment.

　　Work multiple shifts, including weekends, or be asked to work supplemental hours,.

　　Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

　　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-MA1

　　Base Salary Range: $56,000 - $80,000 . 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 & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.

　　The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

　　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