Senior Manager, CMC Process Development

About 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.

About the role

The Senior Manager of CMC Process Development will report to the Sr. Director of Process Sciences and execute activities supporting the late-stage development and BLA readiness activities for our lead program, cretostimogene grenadenorepvec through our CDMOs. They will collaborate on the CMC development plan to monitor the course to BLA and commercialization of cretostimogene. They will be responsible to obtain and aggregate information upstream and downstream, monitor performance against KPIs and apprise Technical Operations/CMC leadership of progress and risks through regular communications and periodic reviews throughout development and in support of filings and approvals. They will remain in close communication with the CDMO and similarly help to address issues, monitor, and facilitate attainment of DS/DP objectives, identify, and recommend how to mitigate process constraints, and ensure progress against strategic and tactical plans.

Location: Remote

Essential Functions

• Work closely with colleagues to support late-stage CMC development for cretostimogene in alignment with corporate objectives.
• Collaborate with the CDMO and leader to closely plan CMC programs (upstream and downstream manufacturing, drug product and analytical activities), from clinical development through clinical supplies for Phase 3 and BLA, including projection of DP needs, budgets, and timelines.
• Develop and implement a strategy and DOE (design of experimentation) for optimizing and controlling quality of bulk DP using CDMOs.
• Execute plans in accordance with cGMP, ICH, and FDA regulations.
• Partner with and maintain regular contact with key stakeholders including, Quality Assurance, Regulatory Affairs, Medical/Clinical Operations, Commercial Operations, Legal, Finance, and Project Management
• Review relevant sections for regulatory submissions.
• Collaborating with colleagues to select and manage Contract Manufacturing Organizations (CMOs) for process optimization, non-GMP and cGMP manufacture and supply of Drug Substance (API) and Drug Product (DP) in support of ongoing clinical programs.
• Monitor the tactical implementation of the manufacturing programs, including delivery of scalable and cost-effective manufacturing routes that meet or exceed the target clinical profile.
• Review cGMP batch records, CMC regulatory and quality documents.
• Collaborate with colleagues and manager to identify late-stage activities supporting BLA completion for cretostimogene.
• Maintain strong relationships with manufacturing partners, participate in business review meetings, review KPIs, provide forecasts, and plan resource utilization.
• Collaborate with Project Management (PMO) to develop timelines and ensure resource availability for project milestones.
• Review manufacturing plans, technical data development reports and BLA submissions.

Qualifications

• Bachelor’s Degree in science (e.g., chemistry, biotechnology, pharmaceutical sciences, or related discipline)
• Eight (8) years of relevant experience in pharmaceutical/biotechnology industry experience in managing CDMOs for the manufacture of non GMP and cGMP DS and DP
• Experience with projects clinical through Phase 3, BLA an including multiple molecule types (cell and gene therapy experience a plus)
• Strong leadership skills with abili