Director, Quality Control Analytical

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, and we apply our R.O.S.E standard to every program and relationship: Reliable, Outcome driven, Scalable, and Excellent!

Position Summary

The Director, Quality Control Analytical is a strategic and operational leader responsible for the overall direction, performance, and continuous improvement of Quality Control Analytical Operations supporting viral vector manufacturing activities at the Rockville site.

This role provides scientific, technical, and people leadership for analytical laboratories supporting AAV, lentiviral, plasmid DNA, and next-generation gene therapy programs from process development through commercial manufacturing.

As a key member of the Site Quality Leadership Team, the Director partners closely with Manufacturing, Process Development, MSAT, Quality Assurance, Regulatory Affairs, Program Management, and Commercial teams to ensure compliant, efficient, and scalable analytical testing operations that support both client success and business growth.

The Director is accountable for laboratory compliance, analytical method lifecycle management, stability programs, inspection readiness, client-facing quality support, operational performance, and organizational development.

This role requires an individual who can effectively balance scientific excellence, regulatory compliance, operational execution, customer expectations, and business objectives within a fast-paced, private equity-backed CDMO environment.

Why Rose BioSolutions:

At Rose, you are not just another layer in a large organization—you are a key contributor in a nimble, high-impact team. We offer:

• Direct exposure to diverse and complex client projects across multiple modalities.
• A collaborative, low-bureaucracy environment where ideas are heard and acted upon.
• Opportunities to grow your technical expertise and take ownership of your work.
• Close interaction with leadership and clients, enabling real influence on project outcomes.

What You'll Do

Strategic Leadership

• Develop and execute the long-term QC Analytical strategy supporting Rose BioSolutions' growth objectives.
• Serve as a key member of the Rockville Site Leadership Team and Quality Leadership Team.
• Build scalable laboratory capabilities supporting clinical and commercial viral vector manufacturing.
• Drive operational excellence initiatives focused on quality, efficiency, productivity, and client satisfaction.
• Lead organizational planning, succession planning, and capability development across the QC Analytical organization.
• Support strategic business initiatives, technology transfers, site expansion activities, and new client onboarding efforts.

Analytical Laboratory Leadership

Provide oversight for analytical testing activities supporting:

AAV Programs

• qPCR and ddPCR
• Vector genome titration
• Potency testing
• Infectivity assays
• Capsid characterization
• Residual impurity testing

Lentiviral Programs

• Vector copy number analysis
• Infectivity testing
• Potency assays
• Replication-competent lentivirus support testing
• Product characterization testing

Plasmid DNA Programs

• Identity testing
• Purity assessments
• Supercoiled DNA characterization
• Endotoxin testing
• Residual impurity testing

Platform Analytical Technologies

• ELISA
• HPLC/UPLC
• CE-SDS
• AUC
• Cell-based bioassays
• Stability testing
• Trending and characterization assays

The Director is responsible for ensuring these platforms remain compliant, scientifically robust, and capable of supporting future client and regulatory expectations.

Quality and Compliance Leadership

The Director provides leadership and oversight for critical Quality Systems including:

• Deviations
• CAPA
• Change Control
• OOS/OOT investigations
• Laboratory investigations
• Method lifecycle management
• Training programs
• Data integrity initiatives
• Inspection readiness programs

The Director serves as the primary escalation point for significant compliance issues impacting laboratory operations and collaborates across the quality organization to ensure sustainable corrective actions and continuous improvement.

Leadership Expectations

At Rose BioSolutions, leaders are expected to:

• Lead with integrity.
• Foster a culture of accountability and respect.
• Develop and mentor high-performing teams.
• Promote collaboration across functions.
• Make data-driven decisions.
• Support employee growth and career development.
• Prioritize quality and compliance in every decision.
• Demonstrate ownership and follow-through.
• Create an environment where employees feel valued, supported, and empowered to succeed.

The Director must consistently model these behaviors while building an engaged and high-performing organization.

COMPENSATION DATA

The pay range for this position is $180,000 – 210,000 per year. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

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.

Perks & 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.

Rose BioSolutions is an equal opportunity employer committed to a diverse and inclusive workforce.