Senior Director/Director of CMC

Leyden Labs is looking for a  

Senior Director/Director of CMC 

who will be responsible for establishing the CMC development plan, working with cross-functional experts, and leading the execution of the plan for drug substance and drug products from pre-clinical through commercial development.  

This role is a key leadership function in the development of intranasal monoclonal antibody candidates and advancement of mucosal delivery platforms, combined with the introduction of new candidates and technology enhancements for programs within Leyden Labs. 

The role will deliver on all CMC aspects of a specific project, working both internally, and externally with partners, contractors and government agencies, to fulfill early to late development stages through regulatory approvals. 

More about the team: 

The Director of CMC will report to the Chief Medical Officer and be a key member of the Clinical Development Management team, as well as manage the CMC team that includes a senior manager, a senior scientist, a principal technician and an associate scientist. 
 
Why would you want to work with us:   

With innovation at the forefront, Leyden Labs is on a mission to develop cutting-edge mucosal protection platforms designed to free people from the threat of respiratory viruses, such as influenza and coronaviruses. We are delighted to be at a pivotal moment in our journey having recently secured a further $70M in funding. Working at Leyden Labs will give you the opportunity to work with a group of talented people and immerse yourself in truly meaningful medical science.  
 

Responsibilities: 

• Provide strategic leadership in the development and optimization of intranasal drug formulations to achieve targeted delivery and efficacy. 

• Select and manage third-party Contract Manufacturing Organizations, negotiate effective technical agreements and ensure the technology transfer of developed processes for GMP clinical manufacturing. 

• Prepare, in conjunction with Regulatory Affairs, the Chemistry and Manufacturing Controls sections of all IND and NDA filings Resource planning including budget, staffing and capacity monitoring of routine operations and enhancement projects. 

• Participate in the planning of timelines, deliverables, and milestones in collaboration with other cross-functional groups. 

• Supervise and motivate study team members to reach set goal. Develop skills of junior members. 

Provide strategic leadership in the development and optimization of intranasal drug formulations to achieve targeted delivery and efficacy. 

Select and manage third-party Contract Manufacturing Organizations, negotiate effective technical agreements and ensure the technology transfer of developed processes for GMP clinical manufacturing. 

Prepare, in conjunction with Regulatory Affairs, the Chemistry and Manufacturing Controls sections of all IND and NDA filings Resource planning including budget, staffing and capacity monitoring of routine operations and enhancement projects. 

Participate in the planning of timelines, deliverables, and milestones in collaboration with other cross-functional groups. 

Supervise and motivate study team members to reach set goal. Develop skills of junior members.