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Job Description

About the role:

As a supervisor of the Cell Culture team, you will coordinate the daily operations of your team, setting clear goals to ensure the completion of tasks. Your role involves applying your expertise to guide team members, addressing challenges that may arise, and ensuring adherence to established practices. You will coach your team, provide performance evaluations, and contribute to resource planning and policy recommendations. While you may occasionally participate in the work being supervised, your primary focus will be on driving your team's success and maintaining a collaborative, productive environment. You will report to the Manufacturing Manager.

This is a night shift role. The shift for this position is 5:45PM - 6:15AM on a 2-2-3 schedule.

How you will contribute:

• Oversee Manufacturing Associates to assure they are working in a cGMP compliant and safe manner. Ensures adherence to the (daily) manufacturing schedule.

• Performs/assists with Processing Steps and/or manufacturing support activities by monitoring process parameters in batch records and control systems.

• Documents/Records cGMP data and information for processing steps and/or equipment activities while following standard operating procedures. Key documentation includes batch records, SAP data entry, and equipment logbooks.
• Coordinate and actively participate in the training and development of Manufacturing Associates.
• Reviews Manufacturing documentation daily (BPR's, logbooks etc.)
• Coordinate Facilities, Metrology, Validation, Product Development, and other non-routine activities with the manufacturing schedule.
• Provide oversight of support groups when working with manufacturing systems. • Provide leadership support during trouble shooting of equipment, operation, and processes.
• May revise and/or create new procedures/documents.
• May support and/or complete deviation investigations. • Conduct annual performance reviews of direct reports.
• Develop goals for direct reports on an annual basis and routinely monitor progress against those objectives.
• Lead / support deviation initiation, investigations, and closure. Participate in cross functional project teams, supports technical transfers with relevant teams/ individuals.
• Analyze staffing needs and make appropriate staffing adjustments/recommendations.
• Complete mandatory training within required timeframe.
• Complete other duties as assigned
• Oversee Manufacturing Associates to assure they are working in a cGMP compliant and safe manner. Ensures adherence to the (daily) manufacturing schedule

What you bring to Takeda:

• Bachelor's Degree (scientific or engineering degree preferred) and 4 or more years of experience in a GMP environment; or Associate degree (scientific or engineering degree preferred) and 6 or more years of experience in a GMP environment; or • High School Diploma or GED and 8 or more years of experience in a GMP environment.
• Previous supervisory experience would be ideal.
• Biotech or Pharmaceutical experience would be ideal.
• Demonstrated application of current Good Manufacturing Practices (cGMP's) and Good Documentation Practices (GDP).
• Advanced understanding of cGMP Biotech or Pharmaceutical operations would be ideal.
• Proficient and knowledgeable in the operation and complex troubleshooting of multiple manufacturing areas (i.e., downstream, upstream and/or media buffer).
• Has some knowledge of non-manufacturing functions such as QC, Regulatory, QA, and/or Materials Management.
• Advanced understanding of the scientific theory of biologics manufacturing and of biotechnology processing.
• Possesses manufacturing equipment understanding, including equipment function and application.
• Ability to analyze department performance and proactively identify and implement strategies to improve.
• Ability to train direct reports and proficient in MS Office and related PC skills.
• Must have passion to innovate and drive for solutions.

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 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.
• May be required to stand and walk frequently and/or for extended periods while overseeing production activities.
• May be required occasionally to lift, push, or pull up to 50 pounds during handling of production equipment and/or materials.
• May be required to climb occasionally (use of stepladders/stairs in production areas, or stairwells in work campus).
• May be required to bend, kneel, or crawl rarely when troubleshooting production equipment.
• Occasional movement of head/neck while using computer applications and handling of production equipment and materials.
• May be required to perform occasional overhead reaching during handling of production materials/files/supplies. Other / Travel Requirements:
• Must have the ability to work on assigned shift (Day or Night).
• Will be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.
• On rare occasions, travel may be required to offsite meetings or training event.

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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#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:

Brooklyn Park, MN

U.S. Base Salary Range:

$86,500.00 - $135,960.00

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

Brooklyn Park, MN

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes