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Manufacturing Supervisor Purification - Nights

Brooklyn Park, Minnesota

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Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.

Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.

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  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

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  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2020.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

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Manufacturing Supervisor Purification - Nights

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Job ID R0022215 Date posted 08/19/2020 Location Brooklyn Park, Minnesota

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Manufacturing Supervisor in our Brooklyn Park, Minnesota office.Here, everyone matters and you will be a vital contributor to our inspiring, bold mission.

As a Manufacturing Supervisor working on the Biologics Manufacturing team, you will be empowered to use your cGMP knowledge while overseeing production processes. The Manufacturing Supervisor is also responsible for the direct oversight of a cGMP Biologics manufacturing operation assuring compliance with safety and cGMP requirements while adhering to the manufacturing schedule. He/she coordinates training and development of Manufacturing Associates, leads/ supports deviation investigations and safety incident investigations. Analyze staffing needs and make appropriate staffing adjustments

SHIFT: 12 Hour shifts, 5:45 pm to 6:00 am, 3 or 4 day work weeks, and a shift stipend included.

ACCOUNTABILITIES: 

  • 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, log books 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
  • 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
  • Other duties as assigned

REQUIRED QUALIFICATIONS:

  • 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 team and detail-oriented and able to work 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.
  • Must have excellent planning and organizational skills.

EDUCATION:

  • Bachelor’s Degree in science or Engineering and 4 or more years of experience in a GMP environment; or
  • Associate’s Degree in Science or Engineering 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

LICENSES/CERTIFICATIONS:

  • N/A

PHYSICAL DEMANDS: 

  • 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

Locations

Brooklyn Park, MN

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0022215

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