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Job Description

Job Title: Drug Substance Supervisor

Location: Thousand Oaks, CA

About the role:

The Drub Substance (DS) Supervisor oversees manufacturing operations while maintaining compliance with environmental, health and safety (EHS) guidelines, current good manufacturing practices (CGMPs) and any other regulation that could apply. Additionally, you will manage DS personnel with their training, development, performance, and other areas. You will report to the Drug Substance Manager.

How you will contribute:

• Manage on the floor operations of your designated responsibilities including oversight of daily production and scheduling.
• Build a team, provide training and ongoing coaching, discipline, and recognition of staff, including annual performance reviews
• Lead technical reviews, investigation, and process improvement projects.
• Contribute to integration and validation of new equipment and process.
• Resolve technical, material, and CGMP issues.
• Approve, and manage documentation for batch and system records for production.
• Communicate with other departments and external vendors to help resolve issues related to equipment, process, and compliance.
• Assess impact of new regulatory guidelines on current practice, initiate document change proposals, prepare/review protocols to justify process changes, assist with training and auditing.
• Owner for implementation of new equipment, system and procedures.
• Participate in internal or external audits as SME for department.
• Knowledge of Cell Culture, Purification, and Buffer/Media manufacturing operations.
• General knowledge of Utility Systems and its impact to manufacturing departments.
• Knowledge of manufacturing equipment operation, including set up and changeover, and commissioning, validation, and troubleshooting.
• Basic scientific understanding of biology (cell culture, microbiology) and chemistry/ biochemistry as it applies to the manufacturing process.
• May have more specific skills in areas depending on need/ opportunity: Aseptic technique, column packing, inoculum operations, chromatography operations.
• Knowledge of clean room management.

What you bring to Takeda:

• Bachelor's Degree preferred (scientific or engineering discipline) plus 3+ years of experience, or AA Degree with 5+ years of experience, or HS Diploma with 7+ years of experience.
• Minimum of 2+ years of experience.

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:

• In general, it's a combination of sedentary work, going into the manufacturing area and supporting the daily activities as needed.
• 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/or 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.
• Must be able to work 4 days a week, 10 hours a day.
• Requires weekend and possibly holiday work
• May be required to more than a 40-hour work week.
• May be required to be available after hours and/or on call.
• May be required to work or be assigned to a different shift.

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.

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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:

U.S. Base Salary Range:

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.

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