Biochemist - Immunoassay - ELISA

BioLegend develops world-class, cutting-edge antibodies and reagents for biomedical research, manufactured in our state-of-the-art facility in San Diego, CA. Our mission is to accelerate research and discovery by providing the highest quality products at an outstanding value, along with superior customer service and technical support.

Job Summary

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

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 in planning raw materials, managing inventory, planning, and schedule kit production.
• Work closely with Product Development to ensure proper transfer of new product from Product Development to Manufacturing.

iACT Competencies

• innovate – Be better, keep improving, be more efficient, creative, and be in the forefront of development.
• Aspire – Have desire, purpose, and ambition challenging ourselves to push the limits and reach new heights.
• Collaborate – Foster teamwork, common goals, selflessness, communication and mutual support
• Transform - Adapt, learn, re-invent and change for future development and growth.

Minimum Qualifications - Education and Experience

• BS/BA in Biology, Chemistry, or other life science-related field.
• Good understanding and some experience with immunoassays such as ELISA or other functional assays.
• 1 year of Good laboratory and Good documentation experience.

Preferred Qualifications – Education and Experience

• 1 year or more working experience in manufacturing under ISO13485 compliance
• 1 year or more hands-on experience with immunoassays such as ELISA
• 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.

Condition of Employment

Concerns regarding COVID-19 continue as positive cases are experienced in the communities in which we operate. Please be aware that, as a condition of employment, BioLegend requires proof of COVID vaccination for all U.S.-based employees (subject to limited exceptions) beginning January 18, 2022.