Associate Director, Quality Control - Stability and Raw Materials

Overview

Create a future where DNA is no longer destiny. Join Rocket Pharma.

Rocket Pharma is a fully integrated, late-stage biotechnology company advancing gene therapies with curative potential for patients with rare and life-threatening diseases. We are a team of creative, compassionate, and driven individuals united by a profound mission of seeking gene therapy cures. Rocket places tremendous value on our people and fosters a collaborative environment where bold ideas thrive and every team member makes a meaningful impact. Our core values guide everything we do: we trust one another, show generosity toward patients, embrace curiosity, and strive to elevate science. Team members receive a competitive total rewards package, including equity participation, 401(k) matching, and excellent health benefits.

Position Summary

Rocket is seeking an Associate Director, QC Stability and Raw Materials. This role is responsible for leading Raw Materials and Stability programs across AAV and LVV platforms, supporting all stages of the product lifecycle from development through commercialization. This role provides strategic and operational leadership to ensure the generation of high-quality, compliant analytical data to support regulatory submissions and product release.

The Associate Director will oversee laboratory operations, stability strategy and execution, and external testing activities, while partnering cross-functionally to advance programs and drive organizational success. This position plays a critical role in ensuring GMP compliance, regulatory readiness, and continuous improvement within QC.

Responsibilities

• Provide leadership and oversight of QC Raw Materials and Stability programs across AAV and LVV platforms, spanning all stages from development through commercialization
• Lead the Lab Management function, including sample management, logbooks, critical reagents and reference standards, KPI trending (analysts and assays), and procurement of laboratory consumables
• Oversee stability programs to ensure timely execution, real-time data trending, and generation of comprehensive stability reports
• Author and review stability reports and summaries for inclusion in INDs, BLAs, and other regulatory submissions
• Monitor and escalate stability trends, ensuring timely communication of potential quality risks and implementation of appropriate actions
• Mentor and develop team members in stability study design, execution, and data analysis, strengthening expertise in biopharmaceutical stability and comparability programs
• Perform and oversee data trending and review for in-process, release, and stability testing to ensure compliance with regulatory filings and global health authority guidelines (e.g., ICH)
• Review and approve investigations related to Invalid Assay (IA), OOS, and OOT results, ensuring robust root cause analysis and effective CAPAs
• Lead and/or author investigations for significant deviations and quality events, including those at external testing laboratories, ensuring timely and compliant resolution
• Drive continuous improvement of SOPs and laboratory processes to maintain compliance while supporting operational and commercial needs
• Ensure GMP compliance across internal laboratories and external vendors, including oversight through internal audit programs
• Establish and maintain robust laboratory systems and controls to ensure the accuracy, reliability, and integrity of QC test results
• Build and maintain effective communication and team structure, developing direct reports and strengthening leadership capability within the organization
• Partner cross-functionally with Analytical Development, Process Development, CMC, and Program Management to align strategies and advance programs
• Plan and allocate resources proactively across platforms to meet program demands and timelines
• Author and review technical documentation, including protocols, reports, SOPs, test methods, and risk/impact assessments
• Ensure QC decisions align with Quality Management System requirements and regulatory expectations
• Oversee generation and availability of analytical datasets (release, stability, validation) for starting materials, drug substance, and drug product to support CMC and regulatory filings
• Identify operational gaps and support budget planning, including both CAPEX and OPEX

Qualifications

• MS with 8 years of Quality Control experience or BS with 12 years of Quality Control experience in biotech industry and in an GMP environment
• In-depth technical, regulatory understanding and experience with Gene/Cell therapy products manufacturing and testing including applicable international regulations/standards (GMP regulations, US FDA and European