Sr. Analyst, QC Analytical

Revance • Newark, CA

10h • Onsite

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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.

Responsibilities

• 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.

Benefits

• 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!

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees