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Job Description

About the role:

As a Manufacturing Supervisor, you will have direct oversight of personnel and daily manufacturing activities of assigned area in a cGMP Biologics manufacturing facility. You will oversee Manufacturing Associates to assure they are working in a cGMP compliant and safe manner. Ensures adherence to the (daily) manufacturing schedule. You will report to the Manager, Manufacturing.

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

How you will contribute:

• Ensure employees are performing all tasks according to SOP’s
• Participate in the coaching, training, and development of employees.
• 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 invetigations.
• 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.

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 highly preferred.
• Biotech or Pharmaceutical experience 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.

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 len