Associate Director, Quality Control

CG Oncology, Inc.; United States; Remote; USD 153,000 - 180,000; Full time

Job summary

Join a forward-thinking company dedicated to battling bladder cancer through innovative immunotherapies. As a key leader in the TechOps QC/Analytical team, you will drive quality control and analytical processes, ensuring compliance with industry regulations. Your expertise will guide the development of critical documentation and support strategic discussions on quality control topics. This role offers a fully remote environment with competitive salaries and comprehensive benefits, allowing you to contribute to meaningful advancements in patient care while enjoying a flexible work-life balance.

Benefits

Flexible Time Off

Retirement Plans

Health Accounts

Insurance Benefits

Performance Bonuses

Equity Options

Comprehensive Well-being Benefits

Qualifications

• 8+ years in the biotechnology industry with experience in drug development.
• Deep knowledge of chemistry, biologics manufacturing, and supply chain.

Responsibilities

• Manage QC processes and documentation for gene therapy products.
• Ensure compliance with cGMP and FDA regulations.
• Communicate complex scientific concepts effectively.

Skills

Organizational Skills

Analytical Skills

Communication Skills

Self-motivation

Knowledge of cGMP

Education

BSc or MSc in Chemistry

Pharmaceutical Sciences

Job description

Are you ready to make a difference in the world and become part of our patient-centered team focused on Attacking Bladder Cancer for a Better Tomorrow? At CG Oncology, we believe that having exceptionally talented individuals who share our passion and enjoy working together can help us achieve our Vision and Mission to benefit patients worldwide.

We are making significant advancements across our pipelines and growing rapidly to meet the needs of patients who cannot wait for our novel immunotherapies. Please review this job posting and our Values; if they resonate with you and align with your expectations, we look forward to hearing from you.

About the role

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 quality control and analytical aspects of our product lifecycle. The role focuses on strategic topics such as comparability, stability, raw materials, and reference standards, involving authoring and reviewing technical documents for clinical and commercial products.

Location

Remote

Essential Functions

1. Function as an internal expert in reference standards, raw materials, stability, comparability, and analytical test methods used for release and characterization of oncolytic Adenovirus for human use.
2. Manage implementation and changes in reference standards and ongoing and new stability studies to meet strategic and operational needs.
3. Review and approve assay development and validation reports, relevant sections of submission documents related to Adenovirus analytical testing, and documentation for regulatory submissions.
4. Author IND, BLA, NDA sections pertaining to raw materials, analytical comparability, stability, and reference standards.
5. Support strategy development for regulatory content, author, review, and approve QC-related content.
6. Communicate complex scientific concepts effectively to diverse groups and external stakeholders.
7. Engage in strategic discussions on QC and analytical topics internally and externally.
8. Provide clear instructions to internal and external stakeholders to support manufacturing activities.
9. Troubleshoot operational and scientific questions, guiding towards solutions.
10. Ensure CMC documentation is complete, organized, scientifically sound, compliant with regulations, and review-ready.
11. Advise manufacturing, Quality, and supply chain on reference standards management and planning.
12. Align quality control systems with industry regulations and expectations.
13. Manage resources effectively in a dynamic, multi-geography environment.
14. Manage work independently in a fast-paced, goal-oriented environment.
15. Possess knowledge of cGMP, FDA, USP regulations related to gene therapy products.

Qualifications

1. BSc or MSc in chemistry, pharmaceutical sciences, or related fields.
2. 8+ years in the biotechnology industry.
3. Experience with drug substance/drug product CMOs and cross-functional teams.
4. Strong organizational and operational excellence skills.
5. Self-motivated with the ability to initiate and follow through independently.
6. Ability to interpret scientific data and draw conclusions.
7. Experience with late-stage or commercial products; BLA experience is a plus.
8. Deep knowledge of chemistry, drug development, biologics manufacturing, and supply chain.
9. Understanding of cGMP, analytical methods, and drug development processes.
10. Excellent communication skills.

Additional Information

CG Oncology does not accept unsolicited resumes from search firms or agencies without an agreement. Resumes submitted without an agreement will be property of CG Oncology, with no fee paid.

Total Rewards

Competitive salaries, performance bonuses, equity, recognition, and comprehensive well-being benefits, including a fully remote environment, flexible time off, holidays, retirement plans, health accounts, insurance, and additional benefits.

Equal Opportunity Employer

We consider all applicants regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status. We aim to promote diversity and sustainability in our hiring practices.

The pay range for this role is $153,000 - $180,000 USD per year (Remote, United States).