Sr. Analyst, Quality Control Analytical

Job Summary:

The Sr. Analyst, Quality Control Analytical of the analytical team will be responsible for testing of in-process, lot release and stability samples for various commercial and clinical drug products. They will author and revise SOPs, deviations, CRs and LIRs. Areas of responsibility include but are not limited to testing samples for Appearance, pH, UV and water content, HPLC, ELISA, western blot and SDS-PAGE as needed. They will participate or lead investigations, reports and process optimization activities as needed, as well as actively participate in group and project teamwork.

Reporting to: Sr. Manager, Quality Control Analytical

Location: Newark, CA (100% onsite)

Salary Range: $89,000 - 122,100

Responsibilities/Essential Duties:

• Perform routine and non-routine release, in-process and stability testing for drug substance, drug product, and other critical reagents and documentation under cGMP.
• Perform Analytical assays such as HPLC (SEC, IEX, HIC, RP, affinity), ELISA, SDS-PAGE, Western Blot, Water Content, UV, Appearance and pH.
• Independently author and lead quality records such as Deviations, Lab Investigations, CAPA, Change Control including leading thorough and timely investigation and/or implementation activities.
• Author and revise SOPs as needed.
• Lead and/or support method development, optimization, transfer, qualification, and validation activities of analytical methods.
• Support equipment and software qualification and maintenance activities.
• Review of laboratory records generated in support of QC testing including procedures, methods, audit trails and other controlled documents.
• Provide training to laboratory analysts as needed, and guide junior analysts in the lab environment, including troubleshooting.
• Work on multiple projects to meet departmental and organization goals.
• Work collaboratively with Manufacturing, QA and Regulatory to support CMC analytical deliverables.

Basic Qualifications:

• Master's degree & 2 years' directly related experience
• Bachelor's degree & 5 years' directly related experience

Preferred Qualifications:

• 5-7 years in a Quality Control laboratory environment (GMP environment) within a commercial setting.
• Hands-on experience with a wide range of analytical techniques such as ELISA, SDS-PAGE, Western Blot, Karl Fisher and HPLC (SEC, IEX, HIC, RP, affinity).
• Writing and or authoring deviations, lab investigations, protocols, SOPs, reports, and data trending.
• Prior experience working in method validations, method transfers, raw material and stability testing is a plus.
• Must be able to maintain data integrity, and understanding of US and international (e.g. EU, ICH, GXP) regulations.
• Ability to manage multiple tasks and meet deadlines with a high tolerance for ambiguity, solutions oriented, and able to problem solve and identify root causes.

Company Summary:

As a commercial-stage biotechnology company focused on innovative aesthetic and therapeutic offerings, Revance is setting the new standard for its clients through disruptive products, and for its employees through industry-leading benefits, which promote financial and physical well-being for all. It's time to rethink everything you thought an employee experience could be.

What Revance invests in you:

• Competitive Compensation including base salary and annual target bonus
• Flexible unlimited PTO, summer & winter shutdowns, and 12 weeks parental leave
• Generous healthcare benefits (Company pays up to 90% of premiums for medical benefits), Employer HSA contribution, 401k match, tuition reimbursement, wellness discounts and much more

Note: Revance has agreed to merge with Crown Laboratories. Upon completion of this merger, benefits are subject to change.

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."

We are an equal opportunity employer. We are a company where diverse backgrounds, experience and viewpoints are valued. Revance does not discriminate in practices or employment opportunities on the basis of an individual's race, color, national or ethnic origin, religion, age sex, gender, sexual orientation, marital status, veteran status, disability, or any other prohibited category set forth in federal or state regulations.