Our client is seeking a Senior Director to lead the formulation development team who are responsible for discovery, chemistry and formulation sciences from bench scale to Ph1 GMP manufacture of lipid nano particle drug products.
DUTIES & RESPONSIBILITIES
- Lead the fomulation team and advance formulation science across different stages of drug development for novel gene editing modalities (oligonucleotides).
- Plan and lead all activities within the department, ensuring progress on projects both internal and external, togher with their compliance to phase appropriate cGMP and SOP's
- Implement new technologies, manage strategic outsourcing, developing and maintaining a budget.
- Leverage expertise in formulation design, DoEs and drug product sciences to advance the discipline
- Advanced degree in a science together with 10 years + experience in Biotechnology
- extensive experience in biologics and proven experience in managing a development team
- Knowledge of process sciences, aseptic technologies, scale up and technology transfer of formulations
- Experience in CMC and regulatory submissions
- Proven experience in oligonucleotide therapeutics and LNP delivery technologies
- Proven leadership and decision making skills
- strong communication skills both written and oral.