Job Title
Biochemist I – GMP
Location(s)
San Diego - BioLegend
About Us
Revvity is a developer and provider of end-to-end solutions designed to help scientists, researchers, and clinicians solve the world’s greatest health challenges. We pair the enthusiasm of an industry disruptor with the experience of a longtime leader. Our team of 11,000+ colleagues from around the globe are vital to our success and the reason we’re able to push boundaries in pursuit of better human health.
Find your future at Revvity
Job Summary
The Biochemist I – GMP position will be responsible for the different stages of manufacturing various BioLegend’s regulated product produced in our US FDA registered cGMP manufacturing facility.
This role will be responsible for formulating and vialing, completing batch records, putting away finished good inventory (FGI), data entry, equipment maintenance and supply inspections & storage. Other responsibilities include buffer preparation and inspection of incoming buffers into the GMP suite, as well as material preparation for Lyophilization and post lyophilization processes.
This role will prepare product/project related documentation and maintain the device history records for all the regulated products and will work closely with product development on new products in order to establish a smooth transition into manufacturing.
The Biochemist I – GMP will work independently and as a team player. The ideal candidate will be organized and detail oriented, have strong communication skills, and is able to work in a very fast paced environment.
Essential Functions
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Prepare various buffers for manufacturing activities.
Perform incoming inspection of raw materials.
Perform formulation and vialing of regulated products, which includes filling, capping, and labeling.
Assist in troubleshooting the manufacturing process.
Maintain batch records and other documentations in compliance with ISO13485:2016 and cGMP.
Maintain/troubleshoot laboratory equipment and manage supplies.
Perform data entry tasks, including processing production orders.
Work as a team to advance multiple projects simultaneously
Other projects or responsibilities may be required.
Minimum Qualifications – Education and Experience
Bachelor’s degree with 1-year biotechnology industry experience.
1 year of working experience with Good Documentation Practices (GDP)
Preferred Qualifications – Education and Experience
Bachelor’s degree in biology, biochemistry, chemistry, or other related areas
Working experience in the Biotechnology industry with quality system knowledge including ISO 13485 or cGMP regulation is a plus.
1 year of experience in a laboratory and/or biotech manufacturing environment, performing filling, bottling, and packaging.
Advanced pipetting skill is highly preferred.
Familiarity with raw material supply receiving and inspection processes.
Excellent verbal and written communication skills
Demonstrated knowledge of aseptic techniques in biosafety cabinet
Demonstrated ability to work well in small groups and adhere to timelines.
Excellent attention to detail and organizational skills
Applicants must be currently authorized to work in the United States on a full-time basis for any employer.
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.
Compensation
The base…