Manufacturing Supervisor - Night Shift

Takeda • Brooklyn Park, MN

3d • Onsite

About The Position

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.

Requirements

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

Nice To Haves

• Previous supervisory experience highly preferred.
• Biotech or Pharmaceutical experience preferred.
• 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.

Responsibilities

• 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.

Benefits

• U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
• U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees