Job Title: Manufacturing Scientist II - Drug Substance
Location: Thousand Oaks, CA About the role:
The Manufacturing Scientist II will support the Manufacturing Sciences (MS) Department specifically in Cell Culture and Purification (Drug Substance) manufacturing processes. You will oversee MS daily manufacturing support, inter-facility, and global process alignments/improvements plans of commercial and clinical manufacturing operations of a multi-product manufacturing plant. You will directly support manufacturing operation process improvements and technical transfers. You will report to the Head of Manufacturing Sciences. How you will contribute:
What you bring to Takeda:
- Provide support to technical and other teams to conduct technology transfer, process optimization, and investigations.
- Prepare, and implement study and validation protocols and reports.
- Support manufacturing investigations, monitoring of process performance to meet quality, yield, capacity, and timelines, troubleshooting GMP equipment and processes, providing technical input for SOPs and production records.
- Assist Validation Master Plans, Process Validation and Material qualification activities to support capital projects, process improvement, technology transfer, and material changes.
- Provide support to audits, change controls, and regulatory submissions.
- 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 bioreactors, chromatography process, ultrafiltration, diafiltration, sterile filtration, process tanks, and CIP/SIP systems.
- Experience preparing and implementing study protocols to design and undertake quality scientific experimentation for purpose of troubleshooting, scale-up, or process optimization.
- Experience interpreting results of experiments and making recommendations for process improvements that reflect understanding of regulatory requirements, our goals, and cost possible effects.
What Takeda can offer you:
- Bachelor's degree in a scientific discipline with 3 - 5 years of relevant experience, MS with 1 - 3 years, or PhD with at least 1 year of relevant experience.
- 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 development opportunities
- Tuition reimbursement
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:
More about us:
- The physical exertion of this position is medium work.
- May lift to 35 pounds when handling samples
- Normal office environment
- May require availability outside of business hours
- 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, wet environment.
- May work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
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 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.
This posting excludes Colorado applicants.
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.
USA - CA - Thousand Oaks - Rancho Conejo