Senior Scientist, Cell-Based BioAssay (CBBA)

Job Description

Located at our large molecule headquarters in RTP, North Carolina, the Senior Scientist position will be the Subject Matter Expert (SME) for CBBA team supporting CBBA and Enzyme Linked Immunosorbent Assays (ELISA). This position is a team member in the Large Molecule & Advance Therapy Medicinal Products Services in a Good Manufacturing Practices (GMP) laboratory environment.

Critical Performance Areas

• Supervise, participate in lab activities and act as SME for CBBA
• Collaborate with the team lead to train, develop and coordinate daily laboratory tasks for the team
• Develop, validate, and transfer analytical methods for the analysis of drugs using CBBA and ELISA according to GMP requirements
• Experience with the following platforms:
  • ELISA
  • MSD-ECL
  • Luminescent or Fluorescent Reporters (Plate Readers)
  • Flow Cytometry
• Generate, interpret data and troubleshoot assays as needed
• Handle multiple projects at the same time and ensure on-time testing and delivery of analytical results to clients
• Communicate effectively with clients providing scientific expertise to projects

Essential Job Functions

• Ensure compliance with GMP regulatory requirements and SOPs
• Review and approve lab notebooks, draft and review protocols and reports
• Investigate under GMP for deviation, non-conformity, OOS, change controls and other quality events
• Train scientists and analysts in the team as needed
• Contribute to process improvements for effective and efficient workflows in the lab
• Maintain inventory, ordering of laboratory supplies and instrument maintenance
• Work collaboratively with cross-functional teams and customers

Requirements

• M.S. or Ph.D. Life Sciences with 5+ years relevant experience or B.A/B.S. with 10+ years relevant experience
• Experience working in GMP or GLP environment
• Strong experience in method development, qualification and validation of CBBA, ELISA, and other emerging technologies
• Client management experience is preferred

Other Desired Skills/Abilities

• Excellent organizational skills, ability to work independently and collaboratively in a team environment
• Strong written and verbal communication skills

This job description is not intended to be all-inclusive. Individuals may perform other related duties to meet the ongoing needs of the organization.

Disclaimer: Solvias US does not currently offer relocation packages or sponsor work visas. All applicants must have the legal right to work in the location of the job posting.

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