Principal Investigator, Downstream Process Development

Revance•Newark, CA

4h•Onsite

About The Position

The Principal Investigator, Purification Process Development will be responsible for leading the scientific studies for development, optimization, and characterization of purification process of Revance’s protein biologic compounds. In addition, the investigator will perform technology transfers, scale up, and troubleshooting of process-related issues, will drive root cause analysis of manufacturing deviations. They will improve scientific understanding of the manufacturing process by collecting and evaluating data throughout production and from lab experimental studies. This person will continuously improve the quality, robustness, and consistency of the process in partnership with Operations, Quality, and other key groups involved in GMP manufacturing. The position requires management of team of scientists.

Requirements

Minimum Required: Ph.D. in Biochemistry, Chemical Engineering, or a related discipline, with 5+ years industry experience
Or
M.S. with 7+ years industry experience
or
B.S. with 10+ years industry experience
At least 5-10 years of pharma/biotech industry experience with understanding of integration of functions within pharmaceutical industry.
Both practical experience with and theoretical knowledge of engineering principles involved in scaling process from development lab to pilot/manufacturing scale.
In-depth protein purification knowledge and experience, including familiarity with AKTA lab-scale and preparative chromatography systems and Unicorn software.
Experience with TFF process development: membrane selection, pressure, cross and flux flow rates
Experience with separation, centrifugation, and filtration operations (depth, dead-end, and TFF).
Proficiency in column-based analytical methods SEC, HIC, IEX, RP; analytical methods such as Mass Spec, binding affinity, or activity assays, SDS-PAGE, Western blotting, IEF.
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.

Nice To Haves

Pharmaceutical process or product development experience is a plus.
Excellent oral presentation and written communication skills are a must.
Good record keeping skills and attention to detail are essential.
Experimental work and statistical analysis of data required.
Proficient in Microsoft Office. Advanced Excel skills required.

Responsibilities

Independently lead and execute Purification Process characterization and development studies.
Install and use of process development equipment, assay, and data analysis technology.
Transfer scientific knowledge and hands-on experience to downstream development and manufacturing teams.
Look for new equipment, methods, and strategies to introduce into new and existing technologies.
Monitor and analyze manufacturing data to provide support for discrepancy investigations, process step validation, process improvements, or equipment troubleshooting.
Create scientifically sound hypotheses using literature information, experimental results, and novel approach to old concepts.
Conduct statistical evaluation of historical process parameters and refine design space with additional DOE experiments to establish robust process control strategy.
Conducting experiments for process characterization and assessment of critical process parameters.
Contribute to teamwork through lab-based activities.
Cross-functional interaction with Quality and other departments.
Technical support of ongoing GMP production and technology transfer to GMP environment.
Execution of projects to reduce discrepancies and increase safety/compliance.
Assignment and execution of tasks in rapidly changing environment according to priorities.
Support of regulatory inspections and filings.
Authorship of technical reports, presentations.
Collaborate in publishing of papers and presentation of work at scientific conferences.
Representation of downstream team expertise during cross-functional CMC meetings
Supervise a downstream team, ensure, and evaluate performance and effectiveness of direct reports and support career development.

Benefits

Competitive Compensation including base salary and annual performance bonus.
Flexible PTO, holidays, and parental leave.
Generous healthcare benefits, HSA match, 401k match, employer paid life and disability insurance, pet insurance, wellness discounts and much more!

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