Our large pharmaceutical client is seeking a Lab Scientist to join their growing Bioanalytical Discovery & Development Sciences team in Spring House, PA. This Scientist will work as part of the immunogenicity assessment team to support all validation and life cycle activities of Anti-Drug Antibody (ADA) and Neutralizing Antibody (NAb) assays for the development of biological drugs. This group is responsible for developing, validating, and conducting bioanalytical methods related to large molecule biotherapeutic drug development across all therapeutic areas of their spanning nonclinical studies to post-market clinical development.
Responsibilities include:
-Coordinate, plan, and execute ADA and NAb assay validations by actively collaborating with team members from method development group to deliver validated methods for bioanalysis support.
-Support immunoassay and cell-based assay platforms with laboratory skills to execute experiments when needed.
-Provide input and identify problems with scientific experiments, analyses/tasks in related areas.
-Produce documents to support ADA and NAb assay validations
-Take data generated in the lab and compose SOP, validation plans, and validation reports
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to
HR@insightglobal.com.
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-M.S. with 2+ years of experience or a B.S./B.A. with 3+ years of experience in Biology or related field
-Prior experience in Anti-Drug Antibody (ADA) and/or Neutralizing Antibody (NAb) assay method development and validation
-Experience with immunoassays and cell-based assays used in the ADA and NAb bioanalysis of biologic drugs
-Experience with composing SOP, validation plan, and validation reports
-Excellent communication skills and the ability to perform effectively in a fast-paced environment
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.