Associate Director, Quality Control

Cg Oncology • Irvine, CA

240d • $153,000 - $180,000 • Remote

About The Position

The Associate Director/Director of QC will be a key leader within the TechOps QC/Analytical team, providing critical technical and authoring expertise to support the quality control and analytical aspects of our product lifecycle. This role will leverage technical and authoring expertise in quality control and analytical sciences, with a primary focus on strategic topics such as comparability, stability, raw materials, and reference standards. The individual will play a critical part in both authoring and reviewing technical documents to support clinical and commercial products.

Requirements

• BSc or MSc in chemistry, pharmaceutical sciences or related discipline.
• 8+ years of experience in the biotechnology industry.
• Experience working with drug substance and/or drug product CMOs and participating in cross functional and virtual teams.
• Strong organizational skills to maintain a high level of productivity, innovation, and priority-setting to complete assignments on-time.
• Ability to interpret scientific data and draw reasonable conclusions.
• Experience working with late stage or commercial products, BLA experience is an asset.
• Strong chemistry and drug development knowledge.
• Problem-solving skills.
• Strong understanding of biological processes and products, experience in Gene Therapy products is an asset.
• In-depth understanding and knowledge of industry practices in biologics manufacturing, supply chain and commercialization.
• Sound knowledge of cGMP regulations and compliance.
• Good understanding of analytical methods and related issues.
• Strong understanding of drug development process from R&D through commercialization.
• Strong written and verbal communication skills.
• Strong organizational skills and ability to effectively manage multiple priorities and projects.

Responsibilities

• Function as an internal expert in reference standard, raw materials, stability, comparability and analytical test methods used for release and characterization of an oncolytic Adenovirus intended for human use.
• Manage implementation and changes in reference standards and ongoing and new stability studies to meet strategic and operational needs.
• Review and approve assay development and validation reports, relevant sections of submission documents pertaining to Adenovirus analytical testing and documentation for submission to regulatory agencies.
• Author IND, BLA, NDA, sections pertaining to raw materials, analytical comparability, stability and reference standards.
• Support strategy development for content provided to regulatory agencies, author, review and approve QC related content.
• Engage in various strategic discussions both internally and externally on QC and analytical related topics.
• Provide clear and concise communications and instructions to internal and external stakeholders to support manufacturing activities related to clinical and commercial products.
• Troubleshoot operational and scientific questions, maintaining direction to a final solution.
• Ensure that CMC documentation is complete, well organized, scientifically sound, of a high quality, aligned with the current regulations, and presented in a manner that facilitates Health Authority reviews.
• Advise manufacturing, Quality and supply chain on management of reference standards and plan accordingly to support ongoing and anticipated activities.
• Ensure quality control system for assigned responsibilities is aligned with and meets quality expectations and the industry regulations.
• Demonstrate strong planning and resource management skills in a dynamic project environment located across multiple geographies.
• Work independently with limited direction in a fast-paced, goal-oriented environment.
• Possess knowledge in cGMP, FDA, USP, regulations and guidelines related to the manufacture and testing of Gene therapy products.

Benefits

• Highly competitive salaries.
• Annual performance/merit reviews.
• Annual performance bonuses.
• Equity.
• Special recognition.
• Fully remote work environment.
• Unlimited flexible time off.
• 14 holidays in 2025.
• 401K with 100% company Safe Harbor match up to 4% of base salary.
• Health (medical, dental, vision) - PPO & HDHP - Cigna/Principal.
• Health spending accounts - HSA (with annual company contribution), FSA, FSA-DC.
• Company paid LTD coverage + voluntary plans for illness & disability protection.
• Company paid life insurance 1x base salary + voluntary plans.
• Additional exclusive benefits - voluntary legal, pet, plus more.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Administration of Human Resource Programs
• Education Level: Master's degree