Manufacturing Supervisor

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Job Description

Manufacturing Supervisor for Upstream/Cell Culture

The Manufacturing Supervisor is responsible for the direct oversight of personnel and daily manufacturing activities within an assigned area of a cGMP Biologics manufacturing facility. You will ensure employees perform all tasks in accordance with approved SOPs, maintain compliance with cGMP requirements, and follow established safety practices. The Manufacturing Supervisor also plays a key role in coaching, training, and developing employees to support a highly capable, compliant, and safety-focused manufacturing team.

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.

• Revise and create new procedures/documents.

• Support and 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 and support deviation initiation, investigations, and closure. Participate in cross functional project teams, supports technical transfers with relevant teams.

• Analyze staffing needs and make appropriate staffing adjustments/recommendations.

Skills and qualifications:

• 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 highly preferred.

• Demonstrated application of current Good Manufacturing Practices (cGMP’s) and Good Documentation Practices (GDP).

• Advanced understanding of cGMP Biotech or Pharmaceutical operations a plus.

• 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 and develop direct reports.

• Must be detail-oriented and able to work in a team in a fast-paced environment.

• Possess excellent written and oral communication skills.

• Proficient in MS Office and related PC skills.

• Must have passion to innovate and drive for solutions.

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:

U.S. Base Salary Range:

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. 

For information about our benefits, please click here.

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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Job Exempt