Manufacturing Specialist Job at Wondfo USA in San Diego

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