Biochemist I – GMP
About The Position
The Biochemist I – GMP is responsible for stages of manufacturing BioLegend regulated products at a US FDA-registered cGMP manufacturing facility. The role includes buffer preparation and inspection, raw-material inspection, formulation and vialing, filling, capping, labeling, finished-goods inventory handling, data entry, equipment maintenance, and supply inspection and storage. It also involves preparing materials 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, assists with troubleshooting, and contributes to multiple projects as part of a team or independently. The ideal candidate is organized, detail-oriented, communicative, and comfortable in a fast-paced environment.
Requirements
- Bachelor’s degree.
- At least 1 year of biotechnology industry experience.
- At least 1 year of experience with Good Documentation Practices (GDP).
- Currently authorized to work in the United States on a full-time basis for any employer.
Nice To Haves
- Bachelor’s degree in biology, biochemistry, chemistry, or a related area.
- Biotechnology industry experience and quality-system knowledge, including ISO 13485 or cGMP regulations.
- At least 1 year of laboratory and/or biotechnology manufacturing experience performing filling, bottling, and packaging.
- Advanced pipetting skills.
- Familiarity with raw-material receiving and inspection processes.
- Excellent verbal and written communication skills.
- Knowledge of aseptic techniques in a biosafety cabinet.
- Ability to work well in small groups and adhere to timelines.
- Excellent attention to detail and organizational skills.
Responsibilities
- Prepare buffers for manufacturing activities.
- Perform incoming inspections of raw materials and buffers.
- Formulate and vial regulated products, including filling, capping, and labeling.
- Assist with 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 support the transition of new products into manufacturing.
- Work as part of a team to advance multiple projects simultaneously.
- Undertake 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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
