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Manufacturing Supervisor - Cell Culture

Brooklyn Park, Minnesota

Overview

Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.

As one of the world’s leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; oncology, gastroenterology, neuroscience, rare diseases, plasma-derived therapies, and vaccines.

Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business units are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Join us and discover a career that is life-changing for you – and life-changing patients all over the world.

Takeda’s Brooklyn Park manufacturing facility provides long-term strategic benefits by enhancing Takeda’s capacity to manufacture additional commercial products and investigational drugs under clinical development. This plant allows Takeda to establish and develop direct commercial bio-manufacturing expertise, and is poised to be a world-class biologics drug substance production facility. When fully constructed, it will be a 215,000 square-foot facility manufacturing multiple antibody products, including Entyvio.

We are a passionate team doing important work that impacts patients’ lives. If you are driven to create better health and a brighter future, join us!

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Success

What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Collaborative
  • Agile
  • Ambitious
  • Analytical
  • Enthusiastic
  • Entrepreneurial

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Opportunity

  • Here, you will feel welcomed, respected, and valued as a vital contributor our global team.

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

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

  • Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2018.

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Manufacturing Supervisor - Cell Culture

Apply Now
Job ID R0013244 Date posted 10/16/2019 Location Brooklyn Park, Minnesota

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Job Description

OBJECTIVES:

  • Responsible for the direct oversight of personnel and daily manufacturing activities of assigned area in a cGMP Biologics manufacturing facility
  • Ensure employees are performing all tasks according to SOP’s, applying cGMP practices and are working in a safe manner
  • Actively participate in the coaching, training and development of employees

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

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Preferred combination of education and experience:

  • 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

Knowledge, competencies and skills:

  • 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.

LICENSES/CERTIFICATIONS:

  • N/A

PHYSICAL DEMANDS: (Identify any physical demands required in the performance of the primary responsibilities of the position).

  • 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

ADDITIONAL US SPECIFIC INFORMATION (FOR US RECRUITMENT ONLY): E.g. Number of years experience, ADA

  • N/A

ADDITIONAL EUROPE SPECIFIC INFORMATION (FOR EUROPEAN RECRUITMENT ONLY): This section should reiterate minimum/essential requirements for role

  • N/A

Locations

Brooklyn Park, MN

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0013244

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