Scientist, Analytical Development – Biologics

Grimaldi Staffing Services

Newark, CA

Newark, CA
30+ days ago



The Scientist, Analytical Development will be part of a team responsible for all aspects of, developing, qualifying and executing advanced technical methodologies within Analytical Development Department. The Associate Scientist will provide role appropriate class leading, current, science-driven, phase appropriate analytical development to support clinical programs to commercial registration and post approval improvements for  projects.


This position is a technical laboratory-based position requiring development, qualification and use of advanced Analytical methodology and working in a collaborative manner with peers in the QC Department, and across other technical groups.  The role requires working knowledge of GXP regulation.



  • Serve as a competent Analytical Development scientist of the company, internally, within collaboration and potentially with CMO’s and to US FDA and other regulatory agencies to ensure company is appropriately represented in technical and compliance matters
  • Develop, validate and execute technical analytical methodologies
  • Utilize complex analytical equipment and associated computer control systems
  • Establish operation collaboratively with QC and R&D groups
  • Be part of the team that establishes, maintains and improves technical operations and project outcomes in the Analytical Development area
  • Work well with a team and work collaboratively across all Laboratory Operations
  • Support projects for phase appropriate in-process and release methodologies
  • Execute analytical and biological methods ensuring compliance with applicable ICH guidelines and global regulations
  • Ensure adherence to GMPs, GLPs, GCPs and GDPs
  • Interact with contract manufacturers and contract testing laboratories
  • Provide support for regulatory submissions
  • Train other qualified staff to ensure effective execution of roles and responsibilities



Minimum Required:

  • Bachelor of Science degree in sciences/engineering


  • M.S / Ph.D. in relevant scientific discipline such as biochemistry, chemistry, pharmaceutical sciences or related filed




  • 5+ years of progressive experience in the biotechnology or pharmaceutical industry



Minimum Required:

  • Analytical Development Expertise in Biologics
  • General laboratory knowledge and skills in SEC, RP-HPLC, IEX, CE-SDS and IcIEF for Biologics; experience in ELISA based assays is a plus
  • GXP regulatory experience
  • Experience developing, validating and executing advanced analytical methodologies
  • Experience in analytical sciences supporting early and late stage clinical and commercial products
  • Commitment to purpose and good communication skills
  • Working knowledge of statistics



  • Have experience of accomplishment in Analytical Development and Biosimilars, as demonstrated by successful regulatory approvals of drug candidates incorporating his/her work
  • Be able to communicate technically and strategically across technical and operational activities and work collaboratively to ensure successful execution
  • Possess strong communication skills
  • Be a self-confident, proactive and driven scientist