Associate Director, Quality Control - Stability and Raw Materials

Rocket Pharmaceuticals•Cranbury, NJ

About The Position

Rocket Pharma 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.

Requirements

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 regulatory requirements, ICH Guidelines, and Quality System Regulations, ICH guidelines) in all phases of product development and commercialization. Including experience performing statistical analysis
Hands-on industry experience in Quality Control authoring, reviewing, and approving various release, stability of drug substance and drug product assays in GMP setting including upstream and downstream GMP Drug Substance manufacturing, and Drug product
Proven track record managing stability programs and COA processes for clinical and commercial products
Hands on experience overseeing a raw materials program
Experience writing stability reports and summaries for inclusion in INDs, BLAs, and other regulatory submissions
Experience creating, revising, and approving SOPs, and reports in accordance with current GMP, FDA, EU, Global, and ICH guidelines and regulations.
Experience performing data review, including trending for in-process testing, release, and stability and identify data trends, to ensure compliance with regulatory filings and ICH or other global health authority guidance documents
Experience authoring, and approving investigations related to Invalid Assay(IA), out-of-specification (OOS) and out-of-trend (OOT) results, coordinating with QC teams to identify root causes and implement corrective and preventive actions (CAPAs).
Experience managing significant deviations and quality events at Contract Testing Laboratories and ensuring thorough resolution to maintain product quality and compliance.
Subject matter expertise on stability-related topics during internal and external audits, inspections, and regulatory interactions.
Strong background and understanding of various analytical methods such as SEC-HPLC, RP HPLC, IEX, SDS-Page, cIEF, AUC, and compendial assays as well as ELISA (Plate base assay), potency assay (cell-based assays), PCR, and testing
Proficiency in data analysis and KPI development to support quality metrics and continuous improvement
Leadership experience and project management skills to support a multi-project environment in small biotech

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