Biochemist I - ELISA

Job Summary

BioLegend is seeking a highly motivated Manufacturing Associate to join the Biomarker Immunoassay team in San Diego. The Manufacturing Associate will be working closely with others in the team to ensure timely manufacturing of high-quality immunoassay products under ISO13485 standards.

This role will be responsible for all aspects of product manufacturing including planning/scheduling, making and testing immunoassay components and kits, troubleshooting issues associated with product quality, and documenting and reviewing production batch records to ensure accuracy and completeness.

Additional responsibilities include working with the Product Development team to ensure proper transfer of new products from Product Development to Manufacturing, filling daily immunoassay kit orders from inventoried components, and making and testing custom products in a timely manner.

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Manufacture kit and kit components including purification and biotinylation, bottling, and assembling according to standard operating protocols.  This includes catalog products and custom products.
• Perform in process testing to ensure the quality of components and kits
• Document, analyze, and review data
• Package kits and transfer with proper documentation.
• Assist planning raw materials, manage inventory, plan and schedule kit production.
• Work closely with Product Development to ensure proper transfer of new product from Product Development to Manufacturing.
• Other projects or responsibilities as may be required.

Minimum Qualifications – Education and Experience

• BS/BA in Biology, Chemistry, or other life science related field
• 1 or more years of hands on experience with immunoassays (i.e. ELISA)

Preferred Qualifications – Education and Experience

• 1 year of Good laboratory and Good documentation experience
• 1 year or more working experience in manufacturing under ISO13485 compliance
• Demonstrated leadership potential

Work Environment & Physical Demands

Lab

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.