Sr Director, CMC Process Development & MSAT

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 Director CMC Process Development & MSAT is responsible for the Technology Transfer, process development and scale up of Cretostimogene (AV) drug substance process. In this technical and strategic leadership role, the individual will lead drug substance activities at contract development and manufacturing organizations (CDMOs) with the goal of delivering clinical and commercial drug product batches meeting the company’s current and future needs.

Location: Remote

Essential Functions

• Lead technology transfer team(s) responsible for end-to-end transfer of knowledge, process and technology developed by the CGO technical teams for vector product manufacturing to CGO chosen manufacturing sites.
• Troubleshoot manufacturing issues at contract & strategic partners. In collaboration with Technical Operations partners (manufacturing, quality, supply, project management, etc.), ensure timely support for tech transfer, product/process investigations, training, and improvement projects.
• Support Tech Ops team in Developing 2nd generation drug substance processes targeting reduced COGs and improved manufacturability , timelines, and development plans in collaboration with broader global team including project management, MS&T, QC, QA, and regulatory members.
• Acts as a Subject Matter Expert for the implementation of phase appropriate process development and optimization, manufacturing, and validation activities at external CDMOs by following the FDA guidance and QbD principles in accordance with documented work plans and cGMP requirements to ensure on time delivery of clinical trial materials (CTM).
• Reviews Draft, Master, and Executed Batch Records, protocols and reports related to all GMP operations related to the finished product.
• Provides technical leadership and communicates clearly and concisely across multiple business functions, building effective relations with internal and external partners.
• Participates in GMP investigations; develops corrective action plans and implements such plans to resolve process and product issues.
• Work collaboratively with Quality Assurance and Regulatory Affairs to ensure a high level of cGMP compliance.
• Assist in the technical aspects of the company’s regulatory filings, including process validation for the upcoming BLA filing.

Qualifications

• Bachelor’s Degree in relevant/scientific field, or extensive relevant experience in lieu of degree. Advance degree is preferred.
• Minimum of fifteen (15) years of experience in the biopharmaceutical industry.
• Work experience with both upstream and downstream aspects of drug substance development and production.
• Experience working with or in a contract manufacturing environment with an in-depth knowledge of unit operations for clinical/commercial drug substance and drug products.
• Knowledge of drug substance and drug product process development.
• Ability to effectively work with external CDMOs to meet the timelines while staying within approved budgets – in a remote or on location capacity.
• Ability to effectively work independently in a team environment with the internal department including, but not limited to, the MS&T, Analytical, Regulatory, Clinical Supplies, and Quality Assurance Department in a fast-paced collaborative environment.
• Ability to travel up to 25% of the time.

Please note that CG Oncology does not accept unsolicited information and/or resumes from search firms or agenci