Scientist - Bioassay GMP

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Scientist - Bioassay GMP

BioLegend

icon San Diego, CA, US, 92121

iconFull Time

icon19 April 2024

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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. Our product expertise covers a diverse set of research areas including Immunology, Neuroscience, Cancer, Stem cells, and Cell Biology. 

Job Summary

The primary role of a Bioassay GMP scientist will be to release GMP products through the management of design and development process under current GMP guidelines.  Bioassay GMP scientist will interact with other departments to maintain continuous project flow while complying with GLP/GMP standards.

Essential Functions

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

  • Follow design and development process under current GMP guidelines
  • Prepare documents required for design and development process in a regulatory compliant manner
  • Optimize and trouble shoot existing assays for testing GMP products
  • Write SOP and Work Instructions in support of new GMP product release
  • Work across functional groups to facilitate new GMP product development
  • Maintain scientific knowledge and critically evaluate scientific literature and industry trends in order to contribute to new GMP product development

 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

  • M.S. in Biology, or a related field with at least 5+ years of relevant laboratory experience
  • Experience in design and development process under current GMP guidelines
  • Experience in cell based assay using primary cells and cell lines
  • 3+ years of experience in tissue/cell culture

 Preferred Qualifications – Education and Experience

  • M.S. in Biology, or a related field with at least 5+ years of relevant laboratory experience in ISO environment
  • Experience in managing project design and development process under current GMP guidelines
  • Expertise in cell based assay using primary cells and cell lines
  • 5+ years of experience in tissue/cell culture

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.