Biotechnician II - GMP

Job Summary

BioLegend is seeking a highly motivated GMP Biotechnician to support our FDA-registered cGMP manufacturing operations. In this role, you’ll work cross-functionally with teams like Quality Assurance and Inventory Control to ensure smooth and compliant production workflows. Your hands-on responsibilities will include filling, capping, labeling products, inspecting supplies, maintaining equipment, and accurately documenting each step of the manufacturing process. You'll also manage finished goods inventory and support lab operations that adhere to strict regulatory standards.

Beyond the lab, you’ll contribute to critical administrative functions such as data entry, scanning and uploading records, processing work orders in our ERP system, and generating Certificates of Analysis (CoAs). You'll also be responsible for label creation, verification, and ensuring accurate device history records are maintained for all regulated products. With 60% of your time focused on lab work and 40% on documentation and administrative tasks, this role offers the perfect balance of technical execution and organizational impact—ideal for candidates who thrive in a detail-driven, regulated environment.

Essential Functions

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

• Perform vialing, and labeling of regulated products.
• Maintain batch records and other documentations that are essential to be in compliance with ISO13485:2016 and MDSAP regulations.
• Maintain laboratory equipment and manage laboratory supplies.
• Receiving materials (inspection, organizing/labeling, & updating logs).
• Printing labels for final product production.
• General buffer formulation.
• Washing lab glassware.
• Data entry responsibilities.
• Other projects or responsibilities may be required.

Minimum Qualifications – Education and Experience

• High school diploma/GED or some college.
• 2 years of relevant experience in a laboratory and/or biotech manufacturing and/or filling/bottling/packaging working environment.

Preferred Qualifications – Education and Experience

• Knowledge of Good Documentation Practices.
• Knowledge of aseptic techniques in biosafety cabinet.
• Ability to pipette small volumes.
• Ability to perform simple math calculations.
• Ability to communicate effectively both orally and in writing
• Working experience in Biotechnology industry with quality system knowledge including ISO 13485 or cGMP regulation is a plus.
• Associate's Degree in Biology, Biochemistry, Chemistry, or other related area.
• Advance pipetting skill is highly preferred.
• Familiar with raw material supply receiving and inspection process.

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.

Applicants must be currently authorized to work in the United States on a full-time basis for any employer.

The base salary range for this full-time position is $21 - $24.50/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 education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process. 

Please note that base pay is only one part of our total compensation package and is determined within a range. This range allows for the successful candidate to have an opportunity to progress within the position and develop at our company. This base pay range does not take into account bonuses, equity, or other benefits which may be applicable and are dependent on the level and position offered.