Manager, Quality Control

CG Oncology, Inc.; United States; Remote; USD 119,000 - 140,000; Full time

Job summary

Join a forward-thinking company dedicated to making a difference in the fight against bladder cancer. As a QC Manager, you will play a pivotal role in ensuring the highest quality standards for innovative immunotherapies. This position offers the opportunity to work independently in a fully remote environment while collaborating with cross-functional teams. You will leverage your expertise in microbiology and analytical testing to support critical QC activities and regulatory submissions. If you are passionate about quality control and want to contribute to groundbreaking therapies, this is the perfect opportunity for you.

Benefits

Flexible Time Off

Health Accounts

Disability Insurance

Life Insurance

Retirement Plans

Equity Options

Performance Bonuses

Comprehensive Well-being Benefits

Qualifications

• 5+ years in the biotech industry with a focus on quality control.
• Deep knowledge of chemistry and drug development processes.

Responsibilities

• Manage QC activities and ensure compliance with regulations.
• Review and approve assay development and validation reports.

Skills

Microbiology Testing

Analytical Test Methods

Regulatory Submissions

Organizational Skills

Scientific Communication

Education

BSc in Chemistry

MSc in Pharmaceutical Sciences

Tools

cGMP Regulations

FDA Guidelines

USP Regulations

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 talented individuals who share our passion and enjoy working together helps 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 meet your expectations from an organization and team, we would like to hear from you.

About the role

The QC Manager will be a key member of the TechOps QC/Analytical team, providing technical expertise in quality control and analytical testing. This role will focus on quality control processes, microbiology, and raw materials, among other critical QC activities. The individual will author and review technical documents supporting clinical and commercial products and contribute to the overall success of the QC function through operational tasks.

Location:

Remote

Essential Functions

• Serve as an internal expert in microbiology testing, raw materials, and analytical test methods for oncolytic adenovirus intended for human use.
• Manage QC activities related to commercialization and post-commercialization, including fill finish, facility, and microbiology events.
• Review and approve assay development and validation reports, and relevant submission documents for regulatory agencies.
• Author sections of IND, BLA, NDA regarding raw materials, comparability, stability, and reference standards.
• Support regulatory strategy development and approve QC content for submissions.
• Communicate complex scientific concepts clearly to diverse internal and external stakeholders.
• Participate in strategic discussions on QC and analytical topics.
• Provide clear instructions to support manufacturing activities.
• Troubleshoot operational and scientific questions to reach solutions.
• Ensure CMC documentation is complete, organized, scientifically sound, and compliant with regulations.
• Advise on microbiology events management and support ongoing activities.
• Align QC systems with industry standards and quality expectations.
• Manage resources effectively in a dynamic, multi-geography environment.
• Work independently in a fast-paced, goal-oriented setting.
• Maintain knowledge of cGMP, FDA, USP regulations related to gene therapy products.

Qualifications

• BSc or MSc in chemistry, pharmaceutical sciences, or related field.
• 5+ years in the biotech industry.
• Experience with drug substance/product CMOs and cross-functional teams.
• Strong organizational and operational excellence skills.
• Independent, self-motivated work style.
• Ability to interpret scientific data and draw conclusions.
• Experience with late-stage or commercial products; BLA experience is a plus.
• Deep knowledge of chemistry, drug development, biologics manufacturing, and regulations.
• Excellent communication skills.

Please note that CG Oncology does not accept unsolicited resumes from search firms or agencies without a contract. Resumes submitted without an agreement will become property of CG Oncology, and no fees will be paid.

Total Rewards

We offer competitive salaries, performance bonuses, equity, recognition, and comprehensive well-being benefits, including a fully remote work environment, flexible time off, holidays, retirement plans, health accounts, disability and life insurance, and additional voluntary benefits.

Our benefits support work-life balance and are tailored to meet the needs of our diverse and growing team.

Equal Opportunity Employment

We consider all applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status. We are committed to fostering diversity and inclusion within our team.

The pay range for this role is $119,000 - $140,000 USD per year, remote (United States).