Job Description

Job Title:

CMC Functional Head (VP/SVP level) - Consultant or FTE - Remote.

Job Description:

Rx Group is recruiting for a dynamic and versatile leader to fill the role of CMC Functional Head at a Boston based, start-up biotech organization with multiple pre-clinical programs.

As a key member of the leadership team, you will play a pivotal role in navigating the complexities of preclinical and clinical development, managing external suppliers, and driving projects from gap analysis to execution. The ideal candidate will have a strong Analytical, Product Development and CMC background with a proven track record of success in advancing complex biologics through to regulatory milestones, possess expertise in CMC strategy and execution, and excel in CDMO and CMO management. The organization aims to deliver multiple IND's in the next two-three years

Responsibilities:

• Lead the CMC function and contribute to the strategic direction of the company's pipeline development.
• Drive project management activities from inception to completion, ensuring timelines, budget, and quality standards are met.
• Oversee the management of external suppliers, including major CDMOs/CMOs, to ensure efficient and effective collaboration.
• Make strategic decisions regarding greenfield manufacturing and establish strong relationships with suppliers globally.
• Collaborate with cross-functional teams to integrate CMC strategies into overall development plans.
• Provide leadership and mentorship to CMC team members, fostering a culture of excellence and innovation.
• Represent the company in interactions with regulatory agencies and external partners.

Next Steps:

If you'd like to learn more, please apply directly or reach out to Hemish Ilangaratne at h.ilangaratne@rx-group.io.