Top 3 Must Have Skill Sets:
Evaluating biological assays to query diverse biology, particularly in the fields of immunology and/or oncology (such as cell-based reporter assays, flow-cytometry and kinetic measurement, Surface Plasmon Resonance) (1+ years of experience)
Research experience (scientific literature) (1+ years of experience)
Plan/Execute Experimental Design (1+ years of experience)
technical writing experience (1+ year of experience)
Excellent oral and written communication skills
Excellent interpersonal skills and problem-solving skills
Day to Day Responsibilities:
Read and research scientific topics to understand the mechanism of actions of biosimilar molecules being developed.
Support the biosimilar drug development that can aid the senior scientists in creating strategies to support the assessment of function across multiple biosimilar programs.
Communicate, and summarize the experimental plans with internal and external partners or CRO.
Review study protocols and reports
Ensure and qualify the quality of data included in the regulatory documents.
Co-author regulatory documents or responses in supporting multiple programs through the regulatory approval process in numerous jurisdictions through authoring of filing documents
Additional responsibilities may include generation of abstracts, posters and publications and participating in domestic and international scientific meetings.
The Scientist will be responsible for supporting in generation of high-quality functional similarity packages that meet the expectations of global regulators and balance feedback from current Amgen programs as well as competitor biosimilars across multiple therapeutic areas.
Education and Qualification:
Doctorate degree in life science (PhD in Immunology, Immuno-oncology or Pharmacology) and/or 2 years of postdoctoral degree
Master’s degree in life science and 2 years of scientific experience in drug development
Strong organizational skills
"This posting is for Contingent Worker, not an FTE"