Lead Analyst, Quality Control Analytical

Job Summary

The Lead Analyst, QC Analytical will be responsible for testing of in-process, lot release, and stability samples for various commercial and clinical drug products and drug substances. The Lead will lead investigations and provide method optimization of methods as subject matter expert from a technical and scientific perspective in troubleshooting laboratory issues. They will review laboratory documentation for accuracy, participate with the team to meet group goals, and perform routine laboratory duties. They will author quality records such as deviations, lab investigation, CAPAs and CRs. They will independently lead projects and author SOPs, protocols, summaries and reports as needed.

Reporting to: Sr. Manager, Quality Control Analytical

Location: Newark, CA (5 days/week onsite)

Salary Range: $117,875 - $162,046

Responsibilities/Essential Duties

• Lead raw material program: vendor selection, sample management, raw material quality records, and specification maintenance.
• 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.
• 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.
• Support equipment and software qualification and maintenance activities.
• Review 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

• Doctorate degree & 2 years’ directly related experience; OR
• Master’s degree & 4 years’ directly related experience; OR
• Bachelor’s degree & 7 years’ directly related experience
  
  

Preferred Qualifications

• 7-9 years in Biochemistry, Biology, or a related pharmaceutical or biotechnology related experience.
• 7-9 years in a Quality Control laboratory environment (GMP environment) with 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).
• Solid experience in the development, optimization and validation of analytical techniques.
• Solid technical training and trouble-shooting experiences.
• Must be independently able to write and author deviations, lab investigations, protocols, SOPs, reports and data trending.
• Prior experience working in method validations, method transfers, raw material and stability testing.
• 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 cause.
  
  

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.