Full-Time

Manager, Quality Control

Confirmed live in the last 24 hours

CG Oncology

CG Oncology

51-200 employees

Develops oncolytic immunotherapy for bladder cancer

No salary listed

Senior

Remote in USA

Remote

Category
Biology Lab & Research
Biology & Biotech
Requirements
  • BSc or MSc in chemistry, pharmaceutical sciences or related discipline.
  • 5+ years of experience in the biotechnology industry.
  • Self-directed individual who can manage work with limited direction in a fast-paced, goal-oriented environment.
  • 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, experience with the principals of operational excellence.
  • A well organized, self-motivated, and independent work style with the ability to initiate and follow-through on assignments.
  • Interpreting scientific data and drawing reasonable conclusions.
  • 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 microbiology testing, raw materials, and additional analytical test methods used for release and characterization of an oncolytic adenovirus intended for human use.
  • Manage commercialization and post commercialization quality control activities. Familiarity with QC for fill finish, facility and microbiology events.
  • Review and approve assay development and validation reports, relevant sections of submission documents pertaining to Adenovirus manufacturing, 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.
  • Excellent technical writing and communication skills; able to articulate complex scientific concepts to diverse functional groups and external stakeholders.
  • Engage in various strategic discussions both internally and externally on QC and analytical related topics.
  • Provides clear and concise communications and instructions to internal and external stakeholders to support manufacturing activities related to clinical and commercial products.
  • Ability to 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 microbiology events (sterility, bioburden, endotoxin, mycoplasma) 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.
  • Strong planning and resource management skills in a dynamic project environment located across multiple geographies.
Desired Qualifications
  • Experience working with late stage or commercial products, BLA experience is an asset.
  • Experience in Gene Therapy products is an asset.

CG Oncology specializes in oncolytic immunotherapy, focusing on treatments that harness the body's immune system to combat cancer, particularly bladder cancer. Their main product, cretostimogene grenadenorepvec, is an immunotherapy delivered directly into the bladder, targeting Non-Muscle Invasive Bladder Cancer (NMIBC) that does not respond to standard treatments like Bacillus Calmette-Guérin (BCG). This treatment has side effects similar to other therapies in the field. CG Oncology differentiates itself by concentrating on improving the quality of life for patients with urologic cancers, allowing them to maintain dignity in their lives. Their goal is to advance the research, development, and commercialization of their immunotherapy treatments, generating revenue through sales to healthcare providers and patients. Recently, they have announced new leadership appointments and will present interim Phase 3 data from their BOND-003 study at a significant urology conference.

Company Size

51-200

Company Stage

IPO

Headquarters

Irvine, California

Founded

2010

Simplify Jobs

Simplify's Take

What believers are saying

  • Cretostimogene grenadenorepvec has a high complete response rate of 75.2% in trials.
  • The FDA granted Fast Track and Breakthrough Therapy designations to cretostimogene grenadenorepvec.
  • CG Oncology raised $437M in their IPO, indicating strong financial backing.

What critics are saying

  • Increased competition from similar bladder cancer treatments may impact market share.
  • Potential regulatory delays could affect commercialization timelines for cretostimogene grenadenorepvec.
  • High clinical trial costs could strain financial resources without additional funding.

What makes CG Oncology unique

  • CG Oncology specializes in oncolytic immunotherapy for bladder cancer treatment.
  • Their leading product, cretostimogene grenadenorepvec, targets Non-Muscle Invasive Bladder Cancer.
  • The company focuses on bladder-sparing therapies, avoiding radical cystectomy.

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Benefits

Remote Work Options

Unlimited Paid Time Off

401(k) Company Match

401(k) Retirement Plan

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Performance Bonus

Health Savings Account/Flexible Spending Account

Company News

Business News Today
Apr 28th, 2025
CG Oncology reports best-in-disease durability data for cretostimogene at AUA 2025

CG Oncology reports best-in-disease durability data for cretostimogene at AUA 2025.

Dealforma
Mar 19th, 2025
CG Oncology Raises $437M in IPO

In 2024, biopharma therapeutics and platforms saw significant IPO activity, raising $6.8 billion across 26 IPOs. Notable IPOs include CG Oncology's $437M in January, Kyverna Therapeutics' $367M in February, Bicara Therapeutics' $362M in August, Septerna's $331M in October, and Upstream Bio's $293M in September. Overall, the sector experienced increased deal activity and higher capital raised compared to 2023, indicating a stronger financing environment.

Stock Titan
Mar 12th, 2025
CG Oncology to Participate in the 40th Annual European Association of Urology Congress with a Series of Key Presentations and Updates

CG Oncology (NASDAQ: CGON) announced its participation in the 40th Annual European Association of Urology (EAU) Congress in Madrid, Spain, from March 21-24, 2025.

Stock Titan
Feb 26th, 2025
CG Oncology to Present at the TD Cowen 45th Annual Health Care Conference

IRVINE, Calif., Feb. 26, 2025 (GLOBE NEWSWIRE) - CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients afflicted with bladder cancer, today announced that Arthur Kuan, Chairman & Chief Executive Officer, is scheduled to present at the TD Cowen 45th Annual Health Care Conference in Boston, MA on Wednesday, March 5, 2025, at 11:10 am ET.

Stock Titan
Dec 13th, 2024
CG Oncology $204M IPO at $28/share

CG Oncology (CGON) has announced a public offering of 8 million shares at $28 each, aiming to raise $204 million. The company is offering 7.3 million shares, with an existing stockholder offering 700,000 shares. The offering is expected to close on December 16, 2024. Underwriters, including Morgan Stanley and Goldman Sachs, have a 30-day option to purchase an additional 1.2 million shares.