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Manufacturing Specialist
3 weeks ago
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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