Manufacturing Specialist

3 weeks ago


San Diego, United States Wondfo USA Full time
Job DescriptionJob DescriptionSalary: $22-$40

Job Description:

Wondfo USA is seeking a Manufacturing Supervisor to fill a role in our San Diego facility. The position will support the development and production of novel diagnostic reagents and materials to support R&D throughout all phases of the product development cycle. Additional areas of responsibility will include generating materials for pre-clinical studies, managing raw material inventories, and supporting pilot/scale-up production activities. Join us to be a part of our diverse, multi-disciplinary team.


Key Responsibilities:

  • Manufacture lateral flow devices (both hands-on and supervising others)
  • Support tech transfer activities from R&D.
  • Support on-site pilot production of immunoassay reagents
  • Assist in optimization and scale-up of early-stage reagent development, manufacturing, and QC
  • Prepare for manufacturing by reviewing the production schedule, calculating raw material requirements, maintaining sufficient buffer and raw material stocks, and assembling materials and supplies
  • Work with Quality to execute and maintain batch records
  • Conduct investigations into pilot line issues related to yield, quality, and throughput
  • Develop and optimize SOPs, forms, batch records, and product reports
  • Provide written and verbal updates to supervisors or department managers
  • Operate and maintain laboratory equipment
  • Manage reagent inventories, order supplies, and track material usage
  • Maintain a safe, clean, and organized laboratory environment

 

Requirements/Qualifications:

  • A bachelor’s degree in life sciences or chemistry
  • 3+ years experiences of hands-on in production facility for lateral flow devices.
  • Familiarity with GMP and GLP
  • 1+ year of supervisory/managing experience
  • Ability to follow instructions precisely and document details
  • Ability to work in fast-paced environment
  • Working knowledge of clean room methods, reagent formulations, and aseptic techniques
  • Mechanical aptitude to operate laboratory equipment, perform basic preventative maintenance, and execute calibration procedures
  • Strong inclination towards safety and quality
  • Ability to learn and develop new technical skills in the laboratory
  • Ability to work in a team and independently
  • Ability to organize and prioritize multiple tasks
  • Enjoys laboratory-based research work and collaboration with other scientists and engineers
  • Experience with process development or manufacturing of diagnostics-based products, in manufacturing scale-up and formulation, or with QC testing is a plus


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