QC Lead, Laboratory Testing

About the Role

At Rose BioSolutions, our capabilities span foundational research with human immune cells and stem cells to the complete advanced therapy manufacturing continuum. We are an established operation with a world-class team of experts, applying our R.O.S.E standard to every program and relationship: Reliable, Outcome driven, Scalable, and Excellent! We are seeking an Associate Director of Quality to join our expanding team.

Quality is at the center of everything we do at Rose BioSolutions (RBS). As a QC Analytical Lead, you will play a critical role in ensuring the integrity, reliability, and timely execution of Quality Control testing that supports the development and manufacture of viral vector products. This position combines hands-on laboratory expertise with operational coordination responsibilities, serving as a key resource within the QC organization to help drive efficiency, compliance, and continuous improvement. The QC Analytical Lead supports daily laboratory operations, testing execution, scheduling, investigation support, document review, training, and cross-functional collaboration. This individual partners closely with Quality Assurance, Manufacturing, Process Development, MSAT, and Program Management to ensure testing activities are aligned with business priorities and customer commitments. The ideal candidate is a collaborative, solutions-oriented professional who thrives in a fast-paced GMP environment and is passionate about advancing quality and operational excellence at RBS.

Responsibilities

• Quality Control Testing & Laboratory Operations
  • Perform and support analytical testing using a variety of methods, including qPCR, ddPCR, HPLC, ELISA, cell-based potency assays, infectivity assays, residual host cell DNA/protein testing, and other molecular, biochemical, and virological techniques used to support product release, in-process testing, characterization, and stability programs.
  • Coordinate daily laboratory activities to support testing priorities, sample turnaround times, and product release timelines.
  • Schedule QC release testing, stability testing, method qualification activities, and special studies to ensure timely execution and reporting.
  • Coordinate sample receipt, testing assignments, and laboratory resources to support evolving business needs and production priorities.
  • Monitor laboratory workflow and proactively identify resource constraints, scheduling risks, and opportunities to improve efficiency.
• Quality Systems & Compliance
  • Review laboratory records, test requests, protocols, reports, SOPs, and quality system records in accordance with GMP requirements and RBS procedures.
  • Ensure laboratory activities are performed in compliance with GMP regulations, data integrity expectations, and internal quality standards.
  • Author, revise, and review controlled documents, including SOPs, forms, work instructions, protocols, technical reports, and specifications.
  • Initiate and support quality records including deviations, CAPAs, change controls, investigations, and risk assessments.
  • Support inspection readiness activities and participate in internal, customer, and regulatory audits.
• Investigation Support & Continuous Improvement
  • Support investigations related to deviations, OOS, OOT, atypical results, and other laboratory events.
  • Assist with technical troubleshooting of assays, instrumentation, and laboratory processes to identify root causes and implement effective corrective actions.
  • Support assay transfers, method implementation, qualification, validation, and lifecycle management activities.
  • Monitor laboratory performance metrics and identify opportunities to improve compliance, throughput, efficiency, and data quality.
  • Contribute to continuous improvement initiatives that strengthen QC operations and support RBS growth objectives.
• Collaboration & Technical Leadership
  • Serve as an experienced laboratory resource, providing guidance on assay execution, GMP documentation practices, and laboratory procedures.
  • Support onboarding, training, and qualification of laboratory personnel while helping foster a culture of quality, accountability, and continuous learning.
  • Participate in laboratory meetings and represent QC in cross-functional discussions.
  • Collaborate with QA, Manufacturing, Process Development, MSAT, Program Management, and other business functions to support project milestones and organizational goals.
  • Support forecasting and planning of QC activities by maintaining testing schedules, tracking stability programs, identifying resource needs, and communicating potential risks to timelines and deliverables.
  • Contribute to departmental initiatives, strategic projects, and other responsibilities as assigned.

Requirements

• Required
  • Bachelor's degree in Biology, Microbiology, Biochemistry, Biotechnology, Molecular Biology, or a related scientific discipline.
  • 5+ years of experience in a GMP Quality Control, analytical, or biopharmaceutical laboratory environment.
  • Demonstrated experience executing and troubleshooting analytical assays in support of biologics, viral vectors, gene therapy products, vaccines, or related modalities.
  • Working knowledge of GMP regulations, laboratory investigations, data integrity requirements, documentation practices, and quality systems.
  • Strong organizational, communication, and problem-solving skills.
  • Ability to effectively balance laboratory testing responsibilities with operational coordination and administrative activities.
• Preferred
  • Experience supporting viral vector or gene therapy testing programs.
  • Experience with assay qualification, validation, transfer, or lifecycle management activities.
  • Experience supporting regulatory inspections or customer audits.
  • Familiarity with electronic quality systems, LIMS, and laboratory data management platforms.

What Success Looks Like

• Demonstrate a strong commitment to quality, scientific excellence, and compliance.
• Effectively coordinate laboratory activities while maintaining high standards of technical execution.
• Build collaborative partnerships across functions to achieve shared goals and customer commitments.
• Proactively identify challenges, communicate risks, and implement practical solutions.
• Serve as a trusted technical resource and positive influence within the QC organization.
• Embrace RBS values by fostering accountability, innovation, continuous improvement, and a customer-focused mindset.

Pay

The pay range for this position is $100,000–120,000 per year. Salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

Benefits

• Competitive base salary with performance-based bonus opportunities.
• Comprehensive health, dental, and vision insurance.
• 401(k) with company contribution.
• Generous PTO and professional development support.

Why Join Us?

• Impact: Every process we design is a step toward a cure. You’ll be making a real impact on the health of people in your community and across the globe.
• Expertise: Work alongside a world-class team of scientists and operational leaders in a "no-ego" environment.
• Stability & Growth: We offer the security of an established operation with the career growth opportunities of a rapidly expanding organization.