Chief Technology Officer
Our client is a biotechnology company. They have asked us to assist them in a search for a Chief Technology Officer.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Holds responsibility for implementing our dual manufacturing strategy, building core internal capabilities and managing our CDMO partners, for both clinical and commercial supply.
- Builds and leads our manufacturing organization that will expand over time, both in the number of employees as well as in the number collaborations.
- Leads up to 4 collaborations with our academic and commercial CDMO partners.
- Oversees a manufacturing and quality organization for up to 10 clinical stage programs and an initial commercial launch as early as 2024.
- Builds a quality team and quality management programs to ensure PAI readiness and continued GMP compliance for all programs.
- Co-leads for supply chain operations via selected platforms, in collaboration with the Chief Operating Officer.
- Holds regular interactions with the board of directors, investors, advisors, and partners.
- Interacts with global regulatory agencies and holds responsibility for authoring and reviewing relevant Pre-IND, IND, and BLA sections, as well as generating responses for the CMC section.
- Works collaboratively with senior management to conduct due diligence and assess business development opportunities.
- An advanced degree in the biomedical, scientific, or engineering field is required.
- Must have 10+ years of manufacturing experience, ideally in both a clinical and commercial context.
- Experience in rare diseases, CNS, oncology or hematology, cell therapy or gene therapy is preferred.
- Must have demonstrated leadership in a manufacturing capacity and team building skills, as well as the ability to perform effectively in a dynamic and evolving environment.
- Excellent working knowledge of FDA and EMA regulations and expectations is required.
- Experience in representing the sponsor in front of regulatory agencies and obtaining regulatory approval is preferred.
- Successful submission of INDs and submission of marketing approval-directed filings is a plus.
- Requires experience interacting with and managing multiple CDMOs, manufacturing partners and vendors.
- A record of successfully managed technology transfers and scaled processes for both clinical and commercial supply is required.
- Must have the ability to collaborate with internal and external stakeholders and a diverse workforce within a cross-functional matrix environment.
- Requires exceptional organizational, analytical, critical thinking, and problem solving abilities.
- Must have a strong attention to detail while working on multiple projects in a fast paced, dynamic start up and scaling environment.
- Must be open to travel to SF/HQ at least once per month.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms and Forbes' list of Top 200 Best Executive Recruiting Firms.