Bioprocess Engineer

Job Summary:

The Bioprocess Engineer will support GMP DS manufacturing operations by providing process development, equipment improvement, technology transfer, data analysis, and engineering oversight. Represent DS in cross functional efforts including equipment validation, regulatory submissions, regulatory agency inspections, and systems compliance. Utilizes technical and processexpertiseto provide training, troubleshooting, process trending, andhands onexecution of cGMP production.

• Reporting to: Manufacturing Manager
• Location: Newark, CA Onsite
• Salary Range: *90,000-$115,000 annually + annual bonus

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

Responsibilities/Essential Duties:

• Ensure manufacturing equipment is fully operational andoptimizedormodifiedfor complex GMP productions.
• Write and review Manufacturing documents such as SOP's, batch records, change controls, and technical reports
• Lead investigations, root cause analysis, writing of deviation reports, change controls, and corrective actions
• Serve as SME in extractables andleachables(E&L), Data Historian, regulatorysubmissionsand facility inspections
• Maintain manufacturing database and perform data analysis
• Provide technical support and guidance for design, development, transfer and implementation of new upstream and downstream processes or process improvements in Manufacturing
• Execute start-up and documentation of new process equipment validation, including factory acceptance test (FAT), site acceptance test (SAT), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
• Provide technical oversight to team in regular day-to-day requirements to execute full cycle of Manufacturing Drug Substance
• Perform routine procedures following written instructions (SOPs, batch records, solution documents, protocols, etc.)while ensuring compliance with established internal control procedures.

Basic Qualifications:

• Bachelor's degree in biological sciences, chemical engineering or related discipline or equivalent professional experience.
• 5 years of experience with pharmaceutical or biotechnology manufacturingprocesses;or equivalent education, training, and experience.
• Advanced experience in a cGMP environment, and a comprehensive understanding of cGMP operations and documentation.
• Intermediate experience with fermenters at 100L scale or greater, or with UF/DF and chromatography equipment. Includes understanding of equipment operation, subcomponent function, and process design.

Preferred Qualifications:

• Advanced experience with process development, transfer, andoptimizationa plus.
• Advanced experience with execution of validation protocolsa plus.
• Advanced experience working with potent/toxic agents a plus
• Intermediate experience with authoring and review of regulatory submissions a plus
• Experience with JMP, SAS, or R software

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.
• Generous Paid Time Off, 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.