30 days old

Associate Scientist\/Scientist, Process Development

Revance Therapeutics Inc.
Newark, CA 94560
Apply Now
Apply on the Company Site
  • Job Code
    122767880
Category: Research & Development
Location: Newark, California

Description

Position Summary

The Associate Scientist/Scientist, Process Development will be responsible for leading the scientific studies for development, optimization and characterization of manufacturing processes and analytical assays for Revance's protein biologic compounds. This individual will play a key role in the continued process verification of commercial manufacturing process for Revance's lead compound DAXI for injection and in supporting Biosimilar process and analytical development programs. In addition, the scientist will execute studies on process characterization, improvements, technology transfers, scale up and trouble-shooting of process-related issues, and will drive root cause analysis of manufacturing deviations. The individual will improve scientific understanding of the manufacturing process by collecting and evaluating data throughout production and from experimental studies. The individual will continuously improve the quality, robustness, and consistency of the process in partnership with Operations, Quality, and other key groups involved in GMP manufacturing.

Essential Duties/Responsibilities
  • Responsible for performing process and analytical development in support of process and formulation development projects
  • Job responsibilities may include analytical method qualification, stability and release testing and testing to support Process and Formulation Development efforts
  • Statistical analysis and interpretation of bioanalytical data and effectively communicating to the project teams.
  • Troubleshooting bioanalytical assays. Installation and use of process and formulation development equipment, assay, and data analysis technology.
  • Continuously improving bioanalytical workflows efficiency and ensuring laboratory capacity meets project demand. Writing and maintaining experimental protocols and facilitate assay optimization and implementation to ensure data quality.
  • Cross-functional interaction with Quality and other departments, including senior staff.
  • Analytical support for ongoing GMP production.
  • Authoring documents like deviations, change control records, protocols, reports, SOPs etc.
  • Execution of projects to reduce discrepancies and increase safety/compliance.
  • Execution and assignment of tasks in an environment characterized by rapidly changing priorities.
  • Support of regulatory inspections and filings.


Education

Ph.D. in Biochemistry, Chemical Engineering, or a related discipline, with 2+ years' industry/academic experience; M.S. with 5+ years' industry experience; or B.S. with 10+ years industry experience

Experience
  • At least 2-10 years of pharma/biotech industry or relevant academic laboratory experience.
  • Proficiency running gel- and column-based analytical methods, including but not limited to SDS-PAGE, Western blotting, IEF, SEC, HIC, IEX, RP, HPLC, Mass Spec, and binding affinity or activity assays with proven ability to troubleshoot these methodologies.
  • Knowledge of moisture measurement technique (Karl Fischer); Protein content measurement techniques like ELISA and AlphaLISA
  • Solid technical training in general laboratory practices is required (eg. buffer preparation, sample dilution, micro-pipetting)
  • Capable of integrating complex pieces of information and providing a cohesive interpretation.
  • Rigorous attention to the details of experimental protocols. Ability to comprehensively document in writing the details of each experimental operation.


Knowledge, Skills and Abilities

Minimum Required:
  • Excellent oral and written communication skills are a must.
  • Good record keeping skills and attention to detail are essential.
  • Proficient in Microsoft Office. Advanced Excel skills required.


Additional Skills:
  • Pharmaceutical process or product development experience is a plus.




PI122767880
Posted: 2020-08-20 Expires: 2020-09-21

Featured Job

Featured Employer

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Associate Scientist\/Scientist, Process Development

Revance Therapeutics Inc.
Newark, CA 94560

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast