Principal Investigator, Downstream Process Development

Job Summary:

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.

Reporting to: Director, Drug Substance Process Development
Location: Newark, CA Onsite
Salary Range: $165,00-185,000 annually + performance bonus

* the final salary offered will depend upon factors that may include but are not limited to the quality and length of experience, education and geographic location.

Essential Duties:

• 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.

Basic Qualifications:

• 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.

Preferred Qualifications:

• 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.

Company Summary:

Revance is a fast-growing global aesthetics and skincare company focused on providing innovative aesthetics and market-leading skincare offerings throughout every stage of life. With a differentiated portfolio of products spanning 60 countries, Revance meets the evolving needs of patients and consumers worldwide through continued innovation and commercialization of new products and treatments.

What Revance invests in you:

• 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!

This section of the job description is required by the American with Disability Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a "qualified individual with a disability" in all aspects of the employment relationship. A "qualified individual with a disability" is "an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job."

Revance is an Equal Opportunity employer. All qualified applicants will receive consideration for employment based on merit, without regard to race, color, religion, sex, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.