Senior Scientist, Materials, Science & Technology (MSAT)

at  CG ONCOLOGY INC

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.

Role: Senior Scientist, Materials, Science & Technology (MSAT)
Location: Remote US-Based

Essential Functions:

• Lead process characterization studies to understand and define CPPs and CMAs of manufacturing processes for novel bladder cancer therapies.
• Design and execute process performance qualification (PPQ) protocols to demonstrate the robustness and reproducibility of manufacturing processes, ensuring consistent product quality and regulatory compliance.
• Collaborate with cross-functional teams, including Process Development, Manufacturing, Quality Assurance, and Regulatory Affairs, to define PC/PPQ and MSAT strategies and ensure alignment with project timelines and objectives.
• Analyze data from PC/PPQ studies and generate comprehensive reports, summarizing key findings, conclusions, and recommendations for process optimization and control.
• Develop and implement statistical approaches for data analysis, including design of experiments (DOE), statistical process control (SPC), and multivariate analysis (MVA), to assess process variability and identify critical process parameters.
• Provide technical support and troubleshooting expertise during manufacturing scale-up and technology transfer activities, ensuring successful execution of PC/PPQ protocols and adherence to regulatory requirements.
• Stay abreast of industry best practices, regulatory guidelines, and emerging trends in process characterization and performance qualification through literature review, participation in scientific conferences, and collaboration with external experts.

Qualifications:

• Bachelor’s degree in Chemical Engineering, Pharmaceutical Sciences, or related field.
• Eight (8) years of relevant experience in process characterization, performance qualification, or related areas within the pharmaceutical or biotechnology industry.
• Technical Proficiency: Proficiency in statistical analysis software (e.g., JMP, Minitab) and Microsoft Office suite. Experience with process modeling software (e.g., Aspen Plus) is desirable.
• Regulatory Knowledge: Familiarity with FDA and ICH guidelines for process validation and qualification activities.

The U.S. target annual salary range for this remote, full-time, position is currently set at $149,000 - $160,000. 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.

• Lead process characterization studies to understand and define CPPs and CMAs of manufacturing processes for novel bladder cancer therapies.
• Design and execute process performance qualification (PPQ) protocols to demonstrate the robustness and reproducibility of manufacturing processes, ensuring consistent product quality and regulatory compliance.
• Collaborate with cross-functional teams, including Process Development, Manufacturing, Quality Assurance, and Regulatory Affairs, to define PC/PPQ and MSAT strategies and ensure alignment with project timelines and objectives.
• Analyze data from PC/PPQ studies and generate comprehensive reports, summarizing key findings, conclusions, and recommendations for process optimization and control.
• Develop and implement statistical approaches for data analysis, including design of experiments (DOE), statistical process control (SPC), and multivariate analysis (MVA), to assess process variability and identify critical process parameters.
• Provide technical support and troubleshooting expertise during manufacturing scale-up and technology transfer activities, ensuring successful execution of PC/PPQ protocols and adherence to regulatory requirements.
• Stay abreast of industry best practices, regulatory guidelines, and emerging trends in process characterization and performance qualification through literature review, participation in scientific conferences, and collaboration with external experts