- Work collaboratively with Research to transfer assays into Analytical Development.
- Independently perform assay development and optimization.
- Collaborate with Process Development and Quality to generate data to support formulation studies, stability studies, and characterization of drug substance and/or drug product.
- Perform analytical method technical transfer, including generating supportive documentation, training, and technical support to Quality Control or central testing laboratories, including providing technical support for assay qualification and validation efforts.
- Compile and present data to program teams.
- Participate in program teams.
- Lead technical sub-teams.
- Author and review test methods, technical reports, and supporting procedures.
- Document all experimental work, supporting information, and data in an electronic lab notebook or test methods in a timely manner.
- Manage and actively participate in, as required, the testing of reference standards, lead stability samples, forced stability samples, toxicology lots, engineering runs, and clinical manufacturing runs, as appropriate.
Requirements of the Scientist II:
- PhD in a life science discipline such as Immunology, Cell Biology, Biological Sciences, Biotechnology, Molecular Biology, or Biomedical Engineering with 2-5 years of relevant analytical development, technical transfer, and quality control experience; or Master’s in a life science discipline such as Immunology, Cell Biology, Biological Sciences, Biotechnology, Molecular Biology, or Biomedical Engineering with 8+ years, or Bachelor’s with 12+ years of relevant analytical development, technical transfer, and quality control experience.
- Experience with cell culture, flow cytometry, and cellular analytical methods. This includes biophysical, bioassay, and/or molecular assay methods.
Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.