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Scientist, Analytical Development

Company: Revance
Location: Newark
Posted on: May 31, 2021

Job Description:

Position Summary

Revance is seeking a highly motivated and accomplished Scientist to join our growing Analytical Development team. This Scientist will be part of a team responsible for all aspects of method development, qualification, and execution for the characterization of complex biologics within the Analytical Development Department. This position requires demonstrated experience with advanced techniques for the biochemical and biophysical characterization of therapeutic proteins. The 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 Revance projects.

This position is a technical laboratory-based position requiring development, qualification and use of advanced Analytical methodology for biologics 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.

Essential Duties/Responsibilities

  • Develop, validate and execute technical analytical methodologies for biologics, including SEC, RP-HPLC, IEX, CE-SDS, LC-MS, SDS-PAGE, ELISA, etc.
  • Write and review analytical methods, protocols, reports, and other technical documents
  • Evaluate data for trends indicative of method, product, and analyst performance
  • Operation, maintenance, and installation of sophisticated analytical instrumentation and associated computer control systems
  • 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 Revance is appropriately represented in technical and compliance matters
  • 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

Education

Minimum Required:

Bachelor of Science degree in sciences/engineering

Experience

Minimum Required:

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

Knowledge, Skills and Abilities

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

Preferred:

  • 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

We are an equal opportunity employer. We are a company where diverse backgrounds, experiences and viewpoints are valued. Revance does not discriminate in practices or employment opportunities on the basis of an individual's race, color, national or ethnic origin, religion, age, sex, gender, sexual orientation, marital status, veteran status, disability, or any other prohibited category set forth in federal or state regulations.

Keywords: Revance, Newark , Scientist, Analytical Development, Other , Newark, California

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