Viela Bio is looking for a highly motivated, entrepreneurial individual to manage all aspects of technical operations for Viela Bio’s portfolio.
Summary of Position
The Head of Technical Operations will be responsible and oversee all aspects of therapeutic candidates’ process development, manufacturing, and supply of clinical and commercial products across Viela Bio portfolio. This individual will be a member of Viela Bio Leadership Team, and report to the Head of Business Development and Operations.
- Develop and implement long-term process development, manufacturing and supply chain strategy and infrastructure appropriate to company evolution – i.e. outsourcing vs. insourcing.
- Manage and lead development projects with external partners and/or contract manufacturing organizations (CDMOs), including cell line development, process development, technology transfer and manufacturing.
- Co-Lead strategy with regulatory on CMC and Commercial regulatory filings and interactions from IND to BLA.
- Develop and manage clinical, and future commercial, supply chains.
- Recruit, coach and develop talents to achieve high performance consistently.
- Defines and executes CMC budgets and timelines consistent with organizationally aligned objectives.
- Play a key role defining “go/no-go” decision points, timelines and allocation of resources in alignment with company objectives, contributing to Viela Bio’s portfolio strategy.
- Demonstrated knowledge and experience in broad ranges of biologic process development, analytics, technology transfer and manufacturing, to support clinical development and commercialization.
- Successful experience in the management of third-party CMOs.
- Successful track record in leading compilation of CMC regulatory submissions, including IND, IMPD, CTA, BLA, MAA or PMA.
- Prior experience with clinical and commercial supply chain management a plus.
- Strong leadership skills. Outstanding strategic thinking, problem-solving, organizational and communication skills.
Education and Minimal Requirement
PhD in Biochemistry or Chemical Engineering or related field with 15+ years of biotechnology experience.