Quality Control Manager

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

Every day we are making significant advancements across our multiple pipelines and are growing rapidly to meet the needs of our patients who cannot afford to wait to benefit from our novel immunotherapies. Please review this job posting and our Values and if they resonate with you and are what you expect from your organization and team, then we would like to hear from you.

We invite you to review our website to learn more about our company and team by visiting our website at https://www.cgoncology.com/careers/#overview.

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Role: Quality Control Manager

Location: Remote US-Based

Essential Functions:

• The Quality Control Manager is responsible for overseeing and managing Quality Control activities including release and stability testing at multiple external testing sites, data review, establishing and maintaining highly productive communication with external partners, working with external QC and QA functions to ensure the timely execution of product testing, and monitoring performance of existing methods and reference materials.
• This position will work with our internal QA team to review and approve external Quality documents such as specifications, sample plans, stability protocols/reports, and deviations.
• The Quality Control Manager is also responsible for managing the collection, shipment, and testing of routine and non-routine product samples, which includes providing completed sample submission forms for our external partners, communicating with both the shipping, and receiving site, and generating memos to release additional sample inventory for testing as needed.

Minimum Qualifications:

• Bachelor’s in Chemistry, Biochemistry, or another related field
• Minimum of seven (7) years of industry experience with a range of biochemical, molecular biology and cell-based bioassays for viral/vaccine product testing.
• Extensive experience in QC for biologics and working with analytical CDMO/CTLs.
• Biologics experience in late-stage development/BLA
• Flexible working hours to meet geographical needs – occasional early days and late evenings can be expected.
• Ability to travel domestically/international as required (estimate - 15%).
• MS in Chemistry, Biochemistry, or another related field
• Experience in cancer immunotherapy or gene therapy highly preferred.
• Experience leading and influencing external CTLs/CMOs.
• Experience in project or program management

Desired Qualifications:

The U.S. target annual salary range for this remote, full-time, position is currently set at $130,000 - $150,000. The actual base salary offered for this role will vary depending on job-related knowledge, skills, market factors, experience and considering internal equity. In addition, to the base salary, CG Oncology offers a very attractive set of Total Rewards (including bonus and equity) and Well-Being Benefits provided as part of the overall compensation package for this role.

Please visit https://www.cgoncology.com/careers/#rewards for a listing of these rewards and benefits.

Total Rewards

CG Oncology offers very competitive and comprehensive Total Rewards, helping to support and reward our global team of high-performing employees focused on developing bladder-saving therapeutics for patients afflicted with bladder cancer.

• HIGHLY COMPETITIVE SALARIES
• ANNUAL PERFORMANCE/MERIT REVIEWS
• ANNUAL PERFORMANCE BONUSES
• EQUITY
• SPECIAL RECOGNITION

Well-Being Benefits

In addition to our Total Rewards, CG Oncology offers a variety of Well-Being Benefits to the meet the majority of the needs of our unique and growing workforce. These benefits are designed to support our team to achieve a healthy balance between work and their personal lives to remain refreshed, engaged, and creating an environment where each person can find a deeper meaning and purpose in their work.

Well-Being Benefits eligibility begins the 1st of the month after hire. While a majority of these benefits are for our US-based workforce, we continue to assess comparable levels of benefits for our international team members that are aligned with country-specific regulations and their national programs offered.

• FULLY REMOTE WORK ENVIRONMENT
• REST AND RECHARGE - Unlimited Paid Time Off (PTO)
• HOLIDAYS – We observe 12 Holidays/year
• RETIREMENT – 401K with 100% company Safe Harbor match up to 4% of base salary
• HEALTH (MEDICAL, DENTAL, VISION) – HMOs, PPOs & HDHP – Anthem/MetLife
• HEALTH SPENDING ACCOUNTS - HSA (with Annual Company Contribution), FSA, FSA-DC
• ILLNESS & DISABILITY PROTECTION – Company Paid LTD Coverage + Voluntary Plans
• LIFE INSURANCE – Company Paid 1 x base salary + Voluntary Plans
• ADDITIONAL EXCLUSIVE BENEFITS – Voluntary Legal, Pet, Plus More

CG Oncology is an Equal Opportunity Employer:

All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. At CG Oncology, we are building a community of intelligent and passionate team members that share our Vision, Mission and Values, and while the biotechnology space can feel limited in BIPOC, non-binary and even female representation, we endeavor to make hiring decisions that will continue to grow and support our team in the direction of maintaining cultural diversity and sustainability.

Please note that CG Oncology does not accept unsolicited information and/or resumes from search firms or agencies for our job postings. Any resumes or client information submitted to our careers page or any employee of CG Oncology by any search firm or agency without an applicable contract in place will become the property of CG Oncology and no fee(s) will be paid.