The Head of Manufacturing Development & Technology (MD&T) is a new role as HMI continues to grow in both complexity, activity, and volume, and will require an ability to create & build capabilities broadly across Technical Operations. There will be extremely close collaboration with our process development leads, our internal manufacturing operations, external manufacturing operations, and Quality. Integrating and improving our Gene Therapy and Gene Editing processes from early development through to commercial manufacturing will be the main scope. This will include strong process understanding, robust technical transfer processes, building a process engineering capability, driving challenging investigations & problems through to resolution, and providing a broad and integrated technical expertise across HMI’s dual platform process strategy. While responsibilities will be highly technical, process oriented, and novel with HMI’s proprietary AAV vector capsids, there is also a strong leadership component. Developing capabilities via experience, experimentation & highly collaborative team building will be significant factors for this role.
Essential Functions and Duties
- Start-up and build an MD&T capability within HMI, as we expand our pipeline, commence clinical development, and prepare platform technologies for commercialization
- Develop mastery of both Gene Therapy and Gene Editing HMI platforms, supporting early development, clinical development, and eventual commercialization, to optimize both CMC development & manufacturing processes.
- Build a process engineering expertise that includes Process Flow Description development, inputs to user requirements, optimization of equipment specifications, process design for staffing/shift, equipment capabilities, and integration of process understanding.
- Develop a capability for process troubleshooting/investigation to support multiple programs and production operations for both internal and external manufacturing.
- Build an amazing team that delivers drama-free support to our amazing technical platforms & patients.
- Provide significant input on the design of an initial, robust data management systems and processes to support development and process data capture & storage, leading rapidly to trending and analyses, technical report authoring, and data support for scientific presentations.
- Provide leadership and management support for MD&T activities to drive a fast paced, highly efficient, learning culture.
- Support the evolving need for technical and project management across our pipeline to ensure on-going success. This scope will be highly driven by pipeline needs and include managing external relationships and technical projects, as HMI grows and evolves.
- Be a champion of HMI’s highly collaborate, transparent, data driven, ‘make it happen,’ culture!
Skills and Experience
- BS & MS in Sciences or Engineering, PhD preferred, or MBA with strong background and experience across manufacturing technologies and operations. 20+ years’ experience in Biologics &/or Virus engineering, development and manufacturing.
- Leadership in developing & optimizing platform technologies to develop highly efficient & user-friendly processes. Proven ability to lead cross functional teams, mentor and coach more junior team members, and develop strong scientific & operational leaders
- Prior experience & significant exposure to broad process development activities and lab operations will be needed. Experience managing early phase, late phase and commercial products & processes is also required.
- Prior experience in technical transfers, qualification, validation, trouble shooting, IND’s, BLA’s, FDA & EMA inspections, process scale-up, and commercial operations support.
- Strong experience leveraging and managing third party firms to effectively deliver capabilities and projects.
- Significant experience with Biologics is a must. Experience with viral vectors highly preferred. Experience in other modalities & technologies appreciated and will be factored in.
- Ability to develop a clear functional strategy aligned closely with HMI’s corporate strategy, prioritize activities, coach & guide team members effectively, and to deal with multiple parallel competing activities is a must. Ability to effectively communicate and collaborate with internal and external stakeholders is essential.
- Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view. Ability to execute and follow-through to completion.
- Self-driven, independently motivated, data driven, and excellent problem solving ability.
Interested candidates should forward a cover letter and Resume / CV to firstname.lastname@example.org