Summary

The Manufacturing Lead will lead and direct operators on day to day tasks as assigned. The lead will organize and drive assigned personnel to meet or exceed operational goals.

Essential Duties

  • Lead staff and resources to support manufacturing build demands.
  • Responsible for all assigned tasks for the shift's operations including safety, quality, company policies, and production.
  • Responsible for training and developing all team members to support the manufacturing plan.
  • Responsible for team members ongoing coaching, and disciplinary problems. 
  • Create and maintain manufacturing material flow, assembly Work Instruction (WI), Batch Record, Traveler in accordance with GMP/Company QMS.
  • Perform inventory check for lab supplies, reagents, and finished products.
  • Ensure lab equipment is within calibration date and all system is functioning correctly. 
  • Regularly communicate with supervisor on daily assignments.
  • Ensure assigned tasks are completed with high standard, and all required documents are filled correctly. 
  • Prepare line set-up for the following shift.  
  • Contribute to continuous improvement to manufacturing efficiency, product quality, and the team's morale. 
  • Escalate issue(s) to supervisor, technical staffs, management, and/or peers in a clear, effective and timely manner. 

Education and/or Experience

  • Degree or equivalent in Biology, Chemistry, Biochemistry, or related field preferred.
  • 1~3 year of laboratory experience including courses in the in Chemistry, Biochemistry, Biology, or Bioscience, or an equivalent combination of education/experience. 
  • Recent graduates are encouraged to apply.
  • 4 - 6yrs experience in an ISO environment and FDA regulated Medical Device industry is a plus.

Other Qualifications

  • Ability to lead a team, and possess leadership skills necessary to create a culture that delivers on commitments.
  • Ability to work with minimal supervision.
  • Excellent communication skills (written and verbal).
  • Detail-oriented with the ability to multitask.
  • Knowledge of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) is a plus.
  • Familiar with Pipettes, bulk reagent prep is a plus.
  • Microsoft Office (Word, Excel, etc). 
  • Contribute and grow in a culture that delivers on commitments.

Physical Demands

  • Comfortable performing repetitive tasks and/or motions.
  • Must be able to lift a minimum of 10 lbs.

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