Senior Director/Director of CMC

About the company

Leyden Labs aims to help people live their lives to the fullest. Our platform targets commonalities of viral families to protect humanity from known and future viruses. Our portfolio of accessible intranasal product candidates may provide people with the freedom to immediately protect themselves from and prevent the spread of many variants of respiratory viruses, including ones in the influenza and coronavirus families.

Job description:

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.

Job requirements

• MS or PhD in Chemistry, biological or medical sciences, biotechnology (or a related scientific discipline)
• Minimum of 10 years+ experience in biotech/pharma industry;8+ years’ experience in a management role
• Proven experience working directly with regulatory bodies such as the FDA, EMA, or other international health authorities.
• Proven expertise in monoclonal antibody development and manufacturing.
• Highly desirable expertise in the following areas:
• Development of intranasal delivery platforms and familiarity with intranasal delivery devices, including selection, validation, and integration into clinical programs
• Development of powder formulation, particulate engineering, DPI device selection, validation, and moisture protection packaging technologies
• Able to foster a collaborative team environment and mentor junior team members
• Able to direct internal and external development activities with cross-functional partners and/or external vendors to drive project completion under rigid timelines.

More about you:

• A true self starter, who works effectively on their own initiative, and is used to working in demanding environments where there is continuous change and ambiguity
• Possess a “can do” mentality and able to pivot rapidly and effectively when faced with challenges.
• Excellent communication skills and strong interpersonal skills.
• Strong analytical and problem-solving skills
• Strong work ethic

Ideally our new colleague starts in May of 2025, but we are willing to wait for the best candidate, we understand you have a notice period or already planned your annual leave. The team works a hybrid on-site schedule, and 2-3 days on-site in the office are required. Therefore, we are looking for someone who is currently residing in the Netherlands or is planning already to relocate to the Netherlands in the next 3 months.

We are an equal opportunity employer;we firmly believe in the added value of a diverse and inclusive group of people with one common goal. We are looking for people who can make an impact and work on a purpose together.

If you’re ready to work at the intersection of pioneering technology and impactful innovation, we’d love to hear from you! Please hit the application button and let me know you’re interested by sending me a short cover letter and your cv and I will get in touch within 5 working days to plan a first call.

Note to all agency recruiters given the important work our employees do, I kindly request that you do not disturb them by approaching our people directly. I’d love to hear from you at jobs@leydenlabs.com

Link to vacancy:

https://leydenlabs.recruitee.com/o/senior-directordirector-of-cmc