Sr. Analyst, QC Analytical

Job Summary:

The Senior Lead Analyst in Analytical Quality Control serves as a technical expert in complex analytical testing and instrumentation, providing leadership, mentorship, and project management for quality control activities within a cGMP environment.

This role is a high-level individual contributor position that bridges technical expertise with leadership responsibilities, ensuring product quality, compliance, and data integrity within a biopharma manufacturing organization.

• Reporting to: Associate Director, Quality Control Analytical
• Location: Newark, CA
• Salary Range: $115k - $130k + 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.

Responsibilities/Essential Duties:

• Analytical Testing: Performing and reviewing complex analytical tests for raw materials, in-process samples, and finished products using techniques such as HPLC, UPLC, LCMS, ELISA, CE-SDS, and various compendial methods.
• Documentation and Compliance: Authoring, reviewing, and approving GMP documentation, including SOPs, test methods, protocols, technical reports, and quality records (deviations, OOS, CAPAs, Change Controls). Ensuring all activities adhere to cGMP and GLP. ICH, FDA, and EMA guidelines.
• Troubleshooting and investigation: Acting as a subject matter expert (SME) to troubleshoot complex equipment and method issues, and leading thorough investigations into out-of-specification (OOS) or out-of-trend (OOT) results using root cause analysis tools.
• Method Lifecycle Management: Leading and supporting the development, optimization, transfer, qualification, and validation of analytical methods for new and existing products.
• Leadership and Training: Mentoring and training junior analysts, guiding staff in laboratory procedures, and potentially managing day-to-day team activities and resource allocation.
• Project and Cross-Functional Collaboration: Leading projects and collaborating with cross-functional teams such as Manufacturing, Quality Assurance, Regulatory, and Analytical Development to meet deliverables and support regulatory inspections.

Basic Qualifications:

• Bachelor of Science in Biochemistry, or a related pharmaceutical biotechnology discipline
• 8+ years in a Quality Control laboratory, specifically within a cGMP biopharmaceutical or pharmaceutical environment for a commercially approved product.
• Must have extensive hands-on experience with relevant analytical instrumentation and software (e.g., Empower, SoftMax, LIMS)
• Must be detail-oriented and have experience in formal technical writing for Quality Control laboratories (e.g., SOPs, Quality Records, Method Validation/Transfer Protocols, Method Validation/Transfer Reports).
• Must have extensive experience in peer-reviewing of Quality Control data.
• Experience with the management of stability studies, stability data analysis, and stability data report generation.
• Experience in scheduling of Quality Control analytical testing for a team of analysts with throughput time adherence.
• Experience with CMO support for external operational management.
• Must have experience in Lean Six Sigma methodologies for bottleneck reductions and high throughput efficiencies in a commercial manufacturing environment.

Preferred Qualifications:

• Master of Science in Biochemistry, or a related pharmaceutical biotechnology discipline
• Effective written and verbal communication skills
• Lean Six Sigma Black Belt or PMP experience using Lean methodologies for process improvement.
• Critical reagent management experience (procurement, preparation, qualification, and management of inventory) is preferred.
• Raw Material management experience in sampling, qualification, and management of testing activities.

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 Americans with Disabilities 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.