Scientist, Immunoassays & Electrophoresis

8 - 10 years experience  •  Biotech/Pharma

Salary depends on experience
Posted on 10/16/17
Rockville, MD
8 - 10 years experience
Biotech/Pharma
Salary depends on experience
Posted on 10/16/17

Basic qualifications:
-Ph.D. or M.S. in Immunology, Virology, Biochemistry, or a related field
-Experience with a variety of immunoassays and/or electrophoresis methods (such as ELISA, Biacore, Luminex, IEF, CE, 1-D and 2-D gels and Blots, etc.)
-Experiences in assay development, qualification and tech transfer
-Exemplary leadership, communication, and problem solving skills
-Experience working in matrix environment with a good understanding of the cross-functional facets of development

Preferred qualifications:
None

Details:
Within the Analytical Development organization, the Scientist of Immunoassays & Electrophoresis will design and develop bioanalytical methods, support product and process development, develop and transfer release and stability assays for GMP testing for Phase 1 and Phase 2, according to Quality by Design principles in partnership with other Technical R&D functions, Quality and Regulatory.

KEY RESPONSIBILITIES

• Develop Immunoassays & Electrophoresis methods according to Analytical Target Profiles
-Support the ATP definition as part of a cross-functional effort
-Evaluate suitable methods/technologies for phase-appropriate analytical control
-Design, develop, optimize, qualify, and transfer of analytical methods for release, stability and in-process control
• Advance multiple, concurrent candidate vaccine development programs by providing analytical supports to other functional groups within the global TR&D organization
-Develop immunoassays for GMP release testing and transfer methods to GMP testing laboratories with compliance
-Provide analytical testing support for process development and serve as immunoassay and/or electrophoresis SME to project teams. Support process understanding
-Lead the characterization of clinical and commercial products using state-of-the-art immunological and electrophoresis technologies for analytics and data interpretation
-Serve as technical lead for platform technologies
• Serve as a SME and technical lead for Immunoassays or Electrophoresis-based assays. Proactively identify potential issues. Develop creative solutions to technical problems to meet project deliverables and milestones
• Write and review SOPs for analytical testing methods and development/qualification reports
• Present new findings at internal and external meetings. Collaborate with scientists from other functions.

  • Requisition ID: WD141640
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