Revance is seeking a highly motivated and accomplished Sr Scientist to join our growing Analytical Development team.
This Sr 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 Preferred: M.S / Ph.D.
in relevant scientific discipline such as biochemistry, chemistry, pharmaceutical sciences or related field Experience Minimum Required: 10 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 individuals 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.