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Scientist -Biosimilar (JP7648)

Thousand Oaks, ca · Biotech/Pharmaceutical
Job Title: Scientist -Biosimilar (JP7648)
Location: Thousand Oaks, CA    
Employment Type: Contract
Business Unit: Biosimilars Operations
Duration: 18 months with likely extensions
Job posting date: 3 September 2020
Note: Remote until COVID-19 restrictions are lifted.
3 Key Consulting is hiring a Scientist for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
Basic Requirements:
  • Doctorate degree in life science (PhD in Immunology, Immuno-oncology or Pharmacology) and/or 2 years of postdoctoral degree OR Master’s degree in life science and 2 years of scientific experience in drug development.
  • Strong organizational skills.
  • 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 programs as well as competitor biosimilars across multiple therapeutic areas.

Top 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).
  • Soft Skills- 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.
Employee Value Proposition:
Review and gather the current landscape and scientific information critical for biosimilar development in the area of CMC, animal and clinical studies conducted in current biosimilar development.
Red Flags: Degree without life science.
Interview Process: Virtual and references
We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.
3KC Talent Acquisition Team

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