Sr. Director Process Development

Sr. Director, Process Development

At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you're not just landing a new role, you become part of a company that's pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values:

Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.

 

This is a hybrid position in our Somerville, Massachusetts office with regular presence in our lab facility.

 

SUMMARY

The Senior Director, Process Development, will provide strategic technical and operational leadership for the Process Development team within Technical Development supporting our company’s gene therapy product portfolio. This role will oversee the design and execution of process development, drive continuous improvement initiatives, advance new unit operations, and technically drive the end-to-end transfer to external manufacturing.  The role must partner successfully cross-functionally within Technical Development and across Technical Operations. 

The ideal candidate will bring deep expertise in cell and gene therapy (CGT) process development, a track record of successful prior innovations, and the leadership acumen to bridge the gap from the laboratory to routine manufacturing.

RESPONSIBILITIES

Strategy

• Provide strategic oversight and day-to-day management of process development workflows internally and externally.
• Collaborate with Analytical Sciences ensuring alignment with process development milestones and regulatory requirements.
• Propose and drive the development of continuous improvements in process, from the smallest detail in execution to an entire unit operation.
• Actively participate in establishing the appropriate technical rigor needed to support strategic decisions including appropriate utilization of small-scale models and the scale down model qualification.

Continuous Improvement and Process Optimization

• Lead a high-performing team of scientists in the design and development of process improvements, leveraging both internal experiments and external vendors.
• Drive high quality execution of rapid optimization cycles and successful comparability studies.
• Drive innovation in continuous improvement activities whether through novel unit operation development or designing the ideal custom consumable part that improves manufacturability.
• Ensure all new processes are developed with a "right first time" approach to facilitate seamless transition to a GMP environment.

External

• Acts as the ultimate technical authority for Process Development, starting with first principles and best practices for process development and extending to strategic approach externally.
• Oversight of the design and execution of external process development activities, ensuring development activities are equivalent to internal standards.

Cross-Functional Leadership & Compliance

• Collaborate across CMC to support regulatory submissions and inquiries.
• Author and review high-quality technical reports, SOPs, and CMC sections of regulatory filings.
• Build and mentor a world-class process development team, fostering individual team member development while in parallel maintaining a culture of scientific rigor and operational excellence.
• Manage resource allocation and timelines to ensure program delivery.

Qualifications

• Education: Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology or a related scientific discipline.
• Experience: 10+ years of progressive experience in the biopharmaceutical industry, with at least 5 years in a people management role specifically within Process Development for Cell and Gene Therapies.
• Technical Expertise: Deep hands-on and strategic knowledge of best practices in process development supporting cell therapy manufacturing. Ideal candidate will have prior CD34+ and/or viral vector experience. Understanding of analytical techniques such as flow cytometry, PCR, etc. that are core to cell therapy product quality is required.
• Track Record: Proven success in developing and transferring processes to external CDMOs and supporting successful regulatory filings (IND/BLA/MAA) including resolving root cause investigations.
• Communication: Exceptional verbal and written communication skills, with the ability to translate complex process development data and decisions into strategic insights for senior leadership.