Biochemist I – GMP
About The Position
The Biochemist I – GMP is responsible for manufacturing regulated BioLegend products at a US FDA-registered cGMP facility. The role includes preparing buffers, inspecting incoming materials, formulating and vialing products, completing batch records, entering data, maintaining equipment and supplies, and handling finished-goods inventory. It also supports material preparation for lyophilization and post-lyophilization processes. The position prepares product- and project-related documentation and maintains device history records for regulated products. The Biochemist works with product development to support smooth transitions of new products into manufacturing, troubleshoots manufacturing processes, and advances multiple projects independently and as part of a team. The ideal candidate is organized, detail-oriented, communicative, and comfortable working in a fast-paced environment.
Requirements
- Bachelor’s degree.
- At least 1 year of biotechnology industry experience.
- At least 1 year of working experience with Good Documentation Practices (GDP).
- Currently authorized to work in the United States on a full-time basis for any employer.
- Excellent verbal and written communication skills.
- Demonstrated ability to work well in small groups and adhere to timelines.
- Excellent attention to detail and organizational skills.
Nice To Haves
- Bachelor’s degree in biology, biochemistry, chemistry, or a related area.
- Biotechnology industry experience with quality-system knowledge, including ISO 13485 or cGMP regulations.
- At least 1 year of laboratory and/or biotech manufacturing experience performing filling, bottling, and packaging.
- Advanced pipetting skills.
- Familiarity with raw-material supply receiving and inspection processes.
- Demonstrated knowledge of aseptic techniques in a biosafety cabinet.
Responsibilities
- Prepare various buffers for manufacturing activities.
- Perform incoming inspection of raw materials and buffers entering the GMP suite.
- Formulate and vial regulated products, including filling, capping, and labeling.
- Assist in troubleshooting manufacturing processes.
- Maintain batch records and other documentation in compliance with ISO 13485:2016 and cGMP.
- Maintain and troubleshoot laboratory equipment and manage supplies.
- Perform data entry, including processing production orders.
- Put away finished-goods inventory.
- Prepare materials for lyophilization and post-lyophilization processes.
- Prepare product- and project-related documentation and maintain device history records for regulated products.
- Work with product development to establish smooth transitions of new products into manufacturing.
- Work with a team to advance multiple projects simultaneously.
- Perform other projects or responsibilities as required.
Benefits
- Medical, dental, and vision insurance options
- Life and disability insurance
- Paid time off
- Parental benefits
- Compassionate care leave
- 401(k) with company match
- Employee stock purchase plan
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Entry Level
