Manufacturing Scientist I - Drug Substance

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Job Description About the role:

The Manufacturing Scientist I will support the Manufacturing Sciences (MS) Department specifically in Cell Culture and Purification (Drug Substance) manufacturing processes. This role is responsible for MS day to day manufacturing support, inter-facility, and global process alignments/improvements initiatives of commercial and clinical manufacturing operations of a multi-product manufacturing plant. This position directly supports manufacturing operation process improvements and technical transfers.

How you will contribute:

• Provide support to technical and/or cross-functional teams to conduct technology transfer, process optimization, and investigations.
• Prepare, and execute risk assessments, manufacturing sciences studies and/or validation protocols and reports, such as Validation Master Plans, Process Validation Lifecycle (mixing validation, process/hold times, membrane/resin lifecycle) and Material qualification in support of capital projects, process improvement, technology transfer, and material changes activities.
• Support manufacturing investigations, monitoring of continuous process performance to meet quality, yield, capacity, and timelines, troubleshooting GMP equipment and processes, providing technical input for SOPs and production records.
• Provide support to audits, change controls, and regulatory submissions, as needed.
• May perform other duties as assigned.

What you bring to Takeda:

• Bachelors degree in a scientific discipline with at least 1 - 3 years of relevant experience
• Basic knowledge of Cell Culture, Purification, process scale-up, troubleshooting, process technical evaluations, statistical analysis, and experimental design.
• Basic knowledge of laboratory and pharmaceutical production equipment including but not limited to bioreactors, chromatography process, ultrafiltration, diafiltration, sterile filtration, process tanks, and CIP/SIP systems.
• Basic knowledge to prepare & executing study protocols to design & undertake quality scientific experimentation for purpose of troubleshooting, scale-up, or process optimization.
• Basic knowledge of lifecycle process validation such as mixing validation, process/hold times, resin/membrane lifecycle.
• Basic knowledge of interpreting results from experiments and validation activities.
• Basic knowledge to potentially recommend process improvements that reflect understanding of regulatory requirements, business objectives, and cost implications.

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. In this role, 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/or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet or hot storage environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• The overall physical exertion of this position is medium work.
• May be required to lift to 35 pounds when handling samples.
• May be required to work in controlled of clean room environments requiring special gowning
• Normal office environment.
• May require availability outside of business hours.
• May work in a loud area that requires hearing protection & other protective equipment to be worn.

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

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 - Thousand Oaks - Rancho Conejo

U.S. Base Salary Range:

$56,000.00 - $88,000.00

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 - Thousand Oaks - Rancho Conejo Worker Type Employee Worker Sub-Type Regular Time Type Full time

Job Exempt

Yes