The Director, CMC and External Manufacturing will be responsible for building our internal CMC capability (process & analytical development) and in the screening, selection and management of external specialist mAb and ADC CDMOs under cGMP. Areas include biologics process and analytical development, process chemistry (Linker-Payload), drug substance and drug product (mAbs and ADCs) from pre-IND through mid-phase clinical studies. The incumbent will be responsible for the delivery of robust, scalable, and cost-effective manufacturing. You will manage our external CDMO’s to ensure that all supply partners are in compliance with appropriate global regulatory standards. In addition, the position provides leadership within a matrix environment defining the company’s overall CMC strategy.
- Build internal CMC capability commensurate with the development stage of the company.
- Provide leadership and oversight/execution of our key operational targets and milestones.
- Qualify and manage external contract development and manufacturing organizations.
- Oversee process and assay technology transfers and the process through supply to clinical sites.
- Drive continuous improvement opportunities, adapts to, and solves challenges and leads the timely resolution of issues.
- Evaluates emerging technologies/applications to improve our products and processes.
- Partner with internal cross functional teams and serve as the liaison to define suitable, compliant, and defendable CMC strategies.
- Prepare technical documentation, publications, and oral presentations.
- Prepare and review relevant CMC and product related sections and documentation for global regulatory submission.
- Reviewing and approving documents related to cGMP operations, including Tech Transfer, process and analytical development reports, qualifications, validations MBRs, and campaign summary report.
- Overseeing the implementation of process improvements at CDMOs.
- Ph.D. and 7-10 + years of experience or MS degree with 9-12 + years of experience in Chemistry, Chemical Engineering, Pharmaceutical Sciences or equivalent with a focus on complex biologics and ADCs.
- Solid experience in a CMC/cGMP environment.
- Technical depth in formulation and process & analytical development.
- Experience in managing CDMOs and oversight of cGMP activities.
- Have a track record in devising and implementing CMC strategies from concept phases (pre IND) through clinical cGMP manufacturing for development candidates..
- Strong project management, interpersonal, presentation and communication skills.
- Collaborative skills and ability to multi-task.
- Desire to strive in a fast-pace environment.
- Strong background of process development and management of external vendors.
- Demonstrated ability and hands-on experience in complex molecule CMC development, technology transfer and GMP manufacturing.
- Significant knowledge of drug substance and drug product manufacturing processes.
- Knowledgeable with FDA, EMEA, ICH and other relevant CMC/Quality regulations and guidelines and experience with IND and other regulatory filings.
- A team player willing to get the job done.
- A caring mentor interested in elevating the careers of those who work with you.
- Travel to various exotic locations as required during production campaigns.
Please send resume to firstname.lastname@example.org