in Breda, Netherlands.
Venn Life Sciences is an Integrated Drug Development Partner offering a unique combination of drug development expertise and clinical trial design and management. This enables us to create, plan and execute drug and medical device development programs effectively and seamlessly for our clients. We have dedicated operations in Ireland, France, Germany, the Netherlands, the UK, the US, and Europe-wide representation.
“”Our vision is to deliver results of the highest quality to our global clients on time and within budget. We do this through developing our staff to be world class in their fields and forming real, lasting relationships with our clients.”
We are currently looking for a CMC Consultant with hands-on experience to join our CMC Team based in Breda, The Netherlands. The successful candidate will have the opportunity to work from one of our European offices and/or home-working with regular visits to our office in Breda.
Reporting to the CMC Director, the successful candidate will be responsible for providing input and guidance on the design, execution and coordination of the CMC elements of client projects related to the development of (bio)pharmaceutical compounds. The role holder will manage all CMC activities, including responsibility for CMC activities outsourced to CMO’s and CRO’s.
If you are seeking a rewarding and challenging career this could be the perfect opportunity for you.
- Provide scientific input to, write or review the CMC plans, protocols, reports, and documents for regulatory purposes
- Provide scientific CMC input to the drug development strategy
- Lead development projects (manage project team, project scope, timelines and budget)
- Contribute to/perform Due Diligence and GAP analyses of CMC development of candidate drugs and deliver advise how to reach critical CMC development milestones
- Participate in multidisciplinary Drug Development teams
- Engage internal and/or external experts (parties) to manage client’s expectations and to address drug development related matters
- Stay up to date with current trends, knowledge, and developments in CMC and proactively identify opportunities to update and increase knowledge and share with others (internally & externally via training, symposia, articles, etc.)
- Proactively participate in business development to identify business opportunities with current and new clients as well as manage Requests for Proposals to acquire contracts with existing and new clients
- Guide, coach and train professionals in the company
Qualifications & Experience:
- MSc. or higher-level qualification
- Minimum of 5 years’ experience in early to late stage CMC development activities
- Proper understanding of the integrated drug development process (incl. CMC, Non-Clinical, Clinical development)
- Experience in process development, manufacturing, and/or analytics
- Experience in Project Management
- Experience in Biologics/biotechnological development is preferred
- Experience in Drug Product formulation is preferred
- Ability to find effective solutions to deal with complex matters
- Excellent influencing, organisational and leadership skills with demonstrated ability to listen, lead and motivate particularly across a multicultural organisation
- Ability to multi-task, set priorities, manage workload and meet strict deadlines
- Team worker, who can also work independently, with strong interpersonal skills, ability to communicate effectively and form positive relationships at all levels in and outside the company
- Excellent networking skills to connect to pharmaceutical / biotech companies
- Flexibility to travel and work at different locations
- Excellent command of English
PLEASE NOTE THAT DUE TO THE HIGH VOLUME OF APPLICATIONS WHICH WE RECEIVE WE WILL ONLY BE ABLE TO REPLY TO CANDIDATES WHOM WE ARE INVITING FOR INTERVIEW.
How to apply: Please forward your CV (in English) by email to Liane Brown-Feaheny, firstname.lastname@example.org
We do not require the services of agencies for this role.