Senior CMC Consultant

Senior CMC Consultant

hVIVO

Breda, Netherlands

Responsibilities:

• Provide scientific CMC input to the drug substance development strategy
• Lead & participate in project teams, manage projects (scope, timelines, budget), and manage CDMOs on behalf of clients
• Perform Due Diligences and GAP analyses of CMC development of candidate drugs and 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
• Provide scientific input to, write or review the CMC plans, protocols, reports, and documents for regulatory purposes. Draft sections of regulatory submissions (e.g. IMPD, IND, MAA, BLA)
• 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:

• BSc. or higher-level qualification
• At least 10 years’ experience in early to late-stage CMC development activities, with a focus on drug substance development and manufacturing of biologics.
• Proper understanding of the integrated drug development process (incl. CMC, Non-Clinical, Clinical development)
• Experience in Project Management
• Experience with CMC development of ATMPs is a plus
• Affinity with authoring of regulatory documents is preferred

Skills:

• 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

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Netherlands      Clinical Research      Pre-clinical Research and Development      hVIVO