Senior Manager, CMC Process Development

CG Oncology; United States; Remote; USD 120,000 - 150,000; Full time

Job summary

A leading company focused on innovative cancer therapies is seeking a Senior Manager of CMC Process Development. This remote role involves overseeing late-stage development and BLA readiness for their lead program, collaborating with various stakeholders and CDMOs to ensure successful project execution.

Qualifications

• At least 8 years of relevant experience managing CDMOs for non-GMP and cGMP manufacturing.
• Experience with clinical to Phase 3 projects, including BLA.

Responsibilities

• Support late-stage CMC development for cretostimogene aligned with corporate objectives.
• Plan CMC programs with CDMOs, including manufacturing and analytical activities.
• Maintain regular contact with key stakeholders including QA, Regulatory, and Project Management.

Skills

Leadership

Problem Solving

Education

Bachelor’s Degree in science

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 exceptionally talented individuals who share our passion and enjoy working together can help 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 awaiting our novel immunotherapies. If our values resonate with you and meet your expectations for an organization and team, we would like to hear from you.

About the role

The Senior Manager of CMC Process Development reports to the Sr. Director of Process Sciences. You will support late-stage development and BLA readiness activities for our lead program, cretostimogene grenadenorepvec, working with CDMOs. Your responsibilities include collaborating on the CMC development plan, monitoring progress toward BLA and commercialization, and maintaining communication with stakeholders and CDMOs to address issues and ensure progress against strategic plans.

Location:

Remote

Essential Functions

1. Support late-stage CMC development for cretostimogene aligned with corporate objectives.
2. Plan CMC programs with CDMOs, including manufacturing, drug product, and analytical activities from clinical development through Phase 3 and BLA, including projections of needs, budgets, and timelines.
3. Develop strategies and experiments for optimizing and controlling the quality of bulk drug product using CDMOs.
4. Execute plans in accordance with cGMP, ICH, and FDA regulations.
5. Maintain regular contact with key stakeholders including QA, Regulatory, Clinical, Commercial, Legal, Finance, and Project Management.
6. Review regulatory submission sections.
7. Manage CMO relationships for process optimization, manufacturing, and supply of Drug Substance and Drug Product.
8. Monitor manufacturing programs, review batch records, regulatory, and quality documents.
9. Support BLA completion activities for cretostimogene.
10. Maintain relationships with manufacturing partners, review KPIs, forecasts, and resource plans.
11. Coordinate with Project Management to develop timelines and resource plans.
12. Review manufacturing plans, technical data, and BLA submissions.

Qualifications

1. Bachelor’s Degree in science (e.g., chemistry, biotechnology, pharmaceutical sciences).
2. At least 8 years of relevant experience managing CDMOs for non-GMP and cGMP manufacturing.
3. Experience with clinical to Phase 3 projects, including BLA, and multiple molecule types (cell and gene therapy experience is a plus).
4. Strong leadership skills with the ability to manage and lead CMC programs.
5. Thorough knowledge of cGMP manufacturing, FDA, and EMA regulations.
6. Proven ability to resolve critical issues effectively.
7. Experience working with senior management.

Note: CG Oncology does not accept unsolicited resumes from search firms or agencies without a contract. Resumes submitted without an agreement will become the property of CG Oncology, with no fees paid.