Senior Manager, CMC Process Development

CG Oncology, Inc.; United States; Remote; USD 153,000 - 180,000; Full time

Job summary

Join a forward-thinking company dedicated to transforming bladder cancer treatment. As a Senior Manager of CMC Process Development, you will play a crucial role in the late-stage development of innovative therapies. This position offers the chance to collaborate with diverse teams, manage critical manufacturing processes, and ensure compliance with industry regulations. With a fully remote work environment and a commitment to employee well-being, this role is perfect for those looking to make a significant impact in the biotechnology field. If you're passionate about advancing healthcare and thrive in a dynamic environment, we want to hear from you!

Benefits

Unlimited Flexible Time Off

401K with Company Match

Health Spending Accounts

Company Paid Life Insurance

Annual Performance Bonuses

Fully Remote Work Environment

Rest and Recharge Benefits

Illness & Disability Protection

Special Recognition Programs

Voluntary Legal and Pet Benefits

Qualifications

• 8+ years in pharmaceutical/biotech managing CDMOs.
• Experience with Phase 3 and BLA submissions.

Responsibilities

• Support late-stage CMC development for cretostimogene.
• Collaborate with CDMO for manufacturing and regulatory submissions.

Skills

Leadership Skills

CMC Process Development

cGMP Knowledge

Regulatory Compliance

Problem Solving

Education

Bachelor’s Degree in Science

Job description

A re 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 ability to be hands-on and lead/manage the CMC programs. • Thorough knowledge of cGMP manufacturing and filings; thorough and relevant knowledge of FDA and EMA regulations
• Strong skills in identifying and resolving critical issues.
• Strong track record in effectively working with senior management.

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.

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

In addition to our Total Rewards, CG Oncology offers a variety of Well-Being Benefits to 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 BENEFITS - Unlimited Flexible Time Off
• HOLIDAYS –In 2025 we will observe 14 holidays
• RETIREMENT – 401K with 100% company Safe Harbor match up to 4% of base salary
• 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.

The pay range for this role is:

153,000 - 180,000 USD per year (Remote (United States))

Technical Operations

Remote (Central Texas location is preferred)