Posted to MedZilla on 11/14/2019


Takeda Pharmaceuticals

US-MN, Manufacturing Supervisor - Cell Culture R0013244-MZ


 
 

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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


Please visit our website at takedajobs.com

 
 


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