Head of LNP Platform, Director to VP
Job ID: EXE-003
- Build and develop for CMC group including process development, CMC management, and pilot plant.
- Oversee all LNP based pipelines starting from pipeline transfer from discovery, process development and clinical manufacturing.
- Engage, support and lead IND preparation with portfolio management, analytical development, quality, supply chain, regulatory and all correlated functions.
- Provide strategic CMC and scientific leadership, make critical decisions on aspects from clinical research to development, medical to regulatory towards commercialization process.
- As a member of the company's senior management team, be responsible for the overall management, development and construction of the technology platform specifically focused in LNP delivery.
- Supervise the CMC team to define project goals, timeline and work activities.
- Provide technology and management support to ensure timely projects progress/completion.
- Strengthen subordinates' career development and management skills through providing coaching/mentoring and guidance/directions.
- Anticipate external trend of changes, respond by making well-judged revisions to CMC, portfolio strategies.
- Contribute to external discussion with collaborators, lead technical and business discussion.
- PhD and/or MD a plus in Chemistry, Biology, Engineering, Pharmacy or Medical, with 5+ years of pharmaceutical or biotechnology experience. At least 2 years on LNP related projects.
- Ability to lead a large group of scientific staffs and a large portfolio of development programs.
- Be familiar with requirements of NMPA, FDA and EMA regulations, ICH guidelines and GMP/GLP as well as drug product development process.
- Expertise in CMC Management, CGT, background in rare disease, blood disease, mRNA, LNP and/or biologics is preferred. Professional knowledge in cellular immunology preferred.
- Able to identifies and implements methods, techniques, procedures and evaluation criteria, and to guide the successful completion of major programs, projects.
- International strategic vision and excellent communication skills.
- Excellent skills in managing direct reports and projects.
- Extraordinary problem solving and technical capabilities.
- Bilingual proficiency in English and Mandarin, strong verbal and written skills.