Associate Director, Quality Control- Stability

Rocket Pharmaceuticals • Cranbury Township, NJ

382d

About The Position

The Associate Director, Quality Control at Rocket Pharma is responsible for overseeing the QC Raw Materials and Stability programs for AAV and LVV gene therapy products. This role requires strong technical expertise in CGT analytical methodologies and effective communication skills to support clinical and commercial manufacturing. The position involves mentoring team members, ensuring compliance with regulatory standards, and driving continuous improvement in quality control processes.

Requirements

• M.S. with 8 years or BS with 12 years of Quality Control experience in biotech and GMP environments.
• In-depth understanding of Gene/Cell therapy products manufacturing and testing regulations.
• Hands-on experience in Quality Control authoring and approving assays in GMP settings.
• Proven track record managing stability programs and COA processes for clinical and commercial products.
• Experience writing stability reports for regulatory submissions.
• Experience creating and approving SOPs in accordance with GMP and regulatory guidelines.
• Experience performing data review and trending for compliance with regulatory filings.
• Experience authoring investigations related to Invalid Assay, OOS, and OOT results.
• Experience managing significant deviations and quality events at Contract Testing Laboratories.
• Subject matter expertise on stability-related topics during audits and inspections.
• Strong background in various analytical methods and proficiency in data analysis.

Nice To Haves

• Strategic thinker with problem-solving skills.
• Ability to motivate and cooperate across departments.
• Efficient decision-making in a fast-paced environment.
• Ability to prioritize and manage multiple projects simultaneously.
• Commitment to informed decision-making based on scientific evidence.

Responsibilities

• Oversee QC Raw Materials and Stability programs across AAV and LVV platforms.
• Ensure timely testing and real-time trending of stability programs, generating stability reports.
• Develop stability reports for regulatory submissions such as INDs and BLAs.
• Monitor and report trends from stability testing results, escalating potential quality issues to management.
• Mentor and train team members on stability study design and data analysis techniques.
• Perform data review for in-process testing, release, and stability, ensuring compliance with regulatory guidelines.
• Review and approve investigations related to Invalid Assay, out-of-specification, and out-of-trend results.
• Manage investigations for significant deviations and quality incidents at CTL sites.
• Ensure continuous improvement of departmental SOPs in line with regulatory guidelines.
• Monitor compliance with GMP in Rocket laboratories and at external vendors through audits.
• Establish communication channels to mentor direct reports.
• Collaborate with Analytical Development, Pharmaceutical Development, and Program management to drive organizational success.
• Write and review technical documents including protocols, reports, and SOPs.
• Ensure QC decisions align with Quality Management System governance and regulatory requirements.
• Coordinate laboratory management structure to build analytical datasets for regulatory filings.
• Identify gaps and assist with annual budget planning.

Benefits

• Competitive compensation package with generous 401K match and stock options.
• Excellent health benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree