About the vacancy
Compliance
Regulatory compliance
Submissions
Clinical R&D
About Your Next Job
In the Leyden Labs' Development team, an opportunity has opened for a
(Sr) Director of CMC
who will be responsible for establishing the CMC development plan of our product candidates 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, in close cross-functional collaboration with our other R&D teams, and externally with partners, contractors and government agencies, to fulfill early to late development stages through regulatory approvals.
About Your Next Colleagues
The (Sr) 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 four (senior) managers, an associate scientist, a principal technician and a technician
About Your Tasks and 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.
About Your Skills and Experience
- 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 is able to pivot rapidly and effectively when faced with challenges.
- Excellent communication skills and strong interpersonal skills.
- Strong analytical and problem-solving skills
- Strong leadership and people management skills
- Thrives to work in an international environment
Where Molecules Meet Opportunities
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, based on the strong data to date (see our recent publication in Science Translational Medicine), and having secured significant funding to execute on our development plans. 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.
Only apply if...
You have a minimum of 10 years+ experience in biotech/pharma industry; 8+ years’ experience in a management role.
You have proven expertise in monoclonal antibody development and manufacturing.
You are eligible to work in EU
We only accept applicants who are eligible to work in the EU
Contact person
Maisi Man
No video available
Leyden Labs is a Dutch biotechnology company employing a novel, non-vaccine approach to fight back against the threat of respiratory viruses. The goal is to provide unprecedented breadth of protection against respiratory viruses right in the palm of the hand of those who need protection the most. The company's product candidates are nasal sprays that are developed following the principles that they must provide protection right at the gate of viral entry (in the airway) and deliver superior breadth of protection. These product candidates offer an opportunity to overcome major limitations of existing vaccine-based protection.