19 days old

Associate Scientist\/Scientist, Process Development

Revance Therapeutics Inc.
Newark, CA 94560
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  • Job Code
    123455114
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 and optimization of Revance's protein biologic compound's fermentation and purification process. 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 development programs. The scientist will execute process characterization experiments, improvements, technology transfers, scale up and trouble-shooting of process-related issues, and will drive root cause analysis of manufacturing deviations. This individual will improve scientific understanding of the manufacturing process by collecting and evaluating data throughout production and from experimental studies. This 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
  • Leading the execution of fermentation and purification process development studies including fermenter, column chromatography, sample handling and solution preparation etc.
  • Execute sample analysis (e.g. pH, conductivity measurement, UV spectrum, HPLC, ELISA, SDS-PAGE etc.)
  • Perform combinations of column chromatography, TFF (UF/DF), centrifugation or other purification methods.
  • Monitoring and analysis of manufacturing data to provide support for discrepancy investigations, process step validation, continuous process improvements, or equipment troubleshooting.
  • Conducting experiments for process development/characterization and assessment of critical process parameters.
  • Installation and use of process development equipment and data analysis technology.
  • Cross-functional interaction with Quality and other departments, including senior staff.
  • Technical support of 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.
  • Experimental work and statistical analysis of data required.


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. In depth fermentation and protein purification knowledge and experience, including familiarity with AKTA lab-scale and preparative chromatography systems and Unicorn software, bioreactors and control software.
  • Practical knowledge of unit operations like UF/DF, filtration etc.
  • Both practical experience with and theoretical knowledge of engineering principles involved in scaling processes from development lab to pilot / manufacturing plant
  • Proficiency running HIC, IEX, RP chromatography.
  • 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.


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




PI123455114
Posted: 2020-09-09 Expires: 2020-10-11

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Associate Scientist\/Scientist, Process Development

Revance Therapeutics Inc.
Newark, CA 94560

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