EVP, Technical Operations

Interstate has been retained to fill an Executive Vice President, Technical Operations for an exciting clinical stage biotech client developing treatments for various immunological and inflammatory conditions.

About the Role

We are seeking a skilled tech ops leader to have strategic and operational oversight over all CMC and Supply Chain.

Responsibilities

• Lead all aspects of manufacturing process design, scale-up, validation, process development, and technology transfer.
• Oversee external manufacturing at CDMOs/CMOs to ensure high-quality and timely delivery of clinical and commercial materials.
• Partner closely with Regulatory Affairs and Quality to ensure GMP compliance and will represent the company in all CMC related interactions with health authorities.
• Lead technical aspects of product launch including commercial process validation, supply chain establishment, manufacturing scale-up and lifecycle management planning.
• Work closely with leadership to build and mentor a high-performing technical team covering these areas.

Qualifications

• PhD in Chemistry, Pharmaceutical Sciences, Chemical Engineering or related discipline.
• Minimum of 15+ years of industry experience, including significant leadership in CMC, process development and manufacturing.

Required Skills

• Proven track record of successfully managing at least one NDA/BLA submission and commercial launch.

Preferred Skills

• Knowledge and experience with injectable formulations (suspensions, solutions) and launch of at least one injectable product.

This individual will be the senior technical voice on the leadership team.