Takeda Pharmaceuticals in Brooklyn Park has an opening for a Night Manufacturing Supervisor
4 days on (12) hour shifts, from 5:45pm -6:15am, and only working 15 days a month
o Responsible for the direct oversight of personnel and daily manufacturing activities of assigned area in a cGMP Biologics manufacturing facility
o Ensure employees are performing all tasks according to SOP’s, applying cGMP practices and are working in a safe manner
o Actively participate in the coaching, training and development of employees
o Oversee Manufacturing Associates to assure they are working in a cGMP compliant and safe manner. Ensures adherence to the (daily) manufacturing schedule.
o Performs/assists with Processing Steps and/or manufacturing support activities by monitoring process parameters in batch records and control systems.
o 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.
o Coordinate and actively participate in the training and development of Manufacturing Associates.
o Reviews Manufacturing documentation daily (BPR’s, log books etc.)
o Coordinate Facilities, Metrology, Validation, Product Development and other non-routine activities with the manufacturing schedule.
o Provide oversight of support groups when working with manufacturing systems
o Provide leadership support during trouble shooting of equipment, operation and processes
o May revise and/or create new procedures/documents
o Conduct annual performance reviews of direct reports
o Develop goals for direct reports on an annual basis and routinely monitor progress against those objectives
o Lead / support deviation initiation, investigations and closure. Participate in cross functional project teams, supports technical transfers with relevant teams/ individuals.
o Analyze staffing needs and make appropriate staffing adjustments/recommendations
o Complete mandatory training within required timeframe
o Other duties as assigned
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Preferred combination of education and experience:
o Bachelor’s Degree in science or Engineering and 4 or more years of experience in a GMP environment; or
o Associate degree in Science or Engineering and 6 or more years of experience in a GMP environment; or
o High School Diploma or GED and 8 or more years of experience in a GMP environment
o Previous supervisory experience highly preferred
o Biotech or Pharmaceutical experience preferred
Knowledge, competencies and skills:
o Demonstrated application of current Good Manufacturing Practices (cGMP’s) and Good
Documentation Practices (GDP).
o Advanced understanding of cGMP Biotech or Pharmaceutical operations a plus
o Proficient and knowledgeable in the operation and complex troubleshooting of multiple
manufacturing areas (i.e. downstream, upstream and/or media buffer)
o Has some knowledge of non-manufacturing functions such as QC, Regulatory, QA, and/or
o Advanced understanding of the scientific theory of biologics manufacturing and of
o Possesses manufacturing equipment understanding, including equipment function and
o Ability to analyze department performance and proactively identify and implement strategies to
o Ability to train and develop direct reports.
o Must be team and detail-oriented and able to work in a fast-paced environment
o Possess excellent written and oral communication skills.
o Proficient in MS Office and related PC skills
o Must have passion to innovate and drive for solutions.
o Must have excellent planning and organizational skills.
PHYSICAL DEMANDS: (Identify any physical demands required in the performance of the
primary responsibilities of the position).
o May be required to stand and walk frequently and/or for extended periods while overseeing
o May be required occasionally to lift, push, or pull up to 50 pounds during handling of production
equipment and/or materials.
o May be required to climb occasionally (use of stepladders/stairs in production areas, or stairwells
in work campus).
o May be required to bend, kneel, or crawl rarely when troubleshooting production equipment.
o Occasional movement of head/neck while using computer applications and handling of
production equipment and materials.
o May be required to perform occasional overhead reaching during handling of production
OTHER / TRAVEL REQUIREMENTS:
o Must have the ability to work on assigned shift (Day or Night)
o 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.
o On rare occasions, travel may be required to offsite meetings or training event
Apply? Questions? Send Resume or Contact:
Senior Corporate Recruiter, Talent Acquisition Partner
Human Resources, Brooklyn Park
Takeda Pharmaceutical Company Limited
9450 Winnetka Avenue North
Brooklyn Park, MN 55445