Biotechnician - BMIA

Job Summary

Bio Legend is seeking a highly motivated Manufacturing Biotechnician to join the Biomarker Immunoassay team in San Diego. ELISA Manufacturing Biotechnician will be working closely with others in the team to ensure timely manufacturing of high-quality immunoassay products under ISO
13485 standards.

This role will be responsible for all aspects of product manufacturing including following production plans, product preparation, making and occasionally testing immunoassay components and kits, in addition to documenting and reviewing production batch records to ensure accuracy and completeness.

• Manufacture ELISA products, primarily responsible for the preparation and coating of ELISA plates, while following established SOPs, production schedules, and quality requirements.
• Accurately formulate buffers, reagents, and solutions to support manufacturing operations and occasionally perform in-process testing assays.
• Operate, maintain, clean, and document laboratory equipment; perform routine preventive maintenance and calibration activities as required.
• Support laboratory operations through inventory management, material handling, housekeeping, and maintaining a safe and organized work environment.
• Complete production records, batch documentation, data entry, and other controlled documentation accurately and in a timely manner.
• When assigned, fill, cap, label, package, and assemble immunoassay kit components and finished products.
• Collaborate with team members to meet production goals, support process improvements, and ensure compliance with ISO 13485, quality, and safety requirements.
• Other projects or responsibilities as may be required.

• High School Diploma or GED with 1+ year of manufacturing, laboratory, or related experience.

• Associate's or Bachelor's degree in Biology, Biotechnology, Biochemistry, or a related scientific discipline.
• Experience in a manufacturing, laboratory, life sciences, or related environment.
• Ability to follow written procedures, work instructions, and standard operating procedures (SOPs).
• Experience with ELISA techniques, immunoassays, or reagent preparation.
• Familiarity with ISO 13485, GMP, GLP, or other regulated quality systems.
• Strong attention to detail and documentation skills.
• Ability to perform repetitive tasks with a high degree of accuracy.
• Basic computer skills, including proficiency with Microsoft Office applications.
• Ability to work independently and collaboratively in a team environment.

While performing the duties of this job, the employee regularly works in a laboratory environment with occasional data entry on a computer. Occasional exposure to a warehouse environment.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to use hands and fingers to handle, feel, or operate objects, tools or controls, and reach with hands and arms. The employee is frequently required to stand, talk and hear.

While performing the duties of this job, the employee regularly works in a laboratory environment with occasional data entry on a computer. Occasional exposure to a warehouse environment.

The base salary range for this full-time position is $17.75 - $23.75/hour. This range reflects the minimum and maximum target for a new hire in this position. The base pay actually offered to the successful candidate will take into account internal equity, work location, and additional factors, including job-related skills, experience, and relevant…