Manager of Nce Development and Maintenance

hace 2 semanas

Barcelona, Barcelona, España Galderma A tiempo completo

With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the leading company solely dedicated to skin and advancing the future of dermatology.

We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration.

Above all, they must be passionate about doing something meaningful for consumers, patients and the healthcare professionals we serve every day.

We aim to empower each employee and to promote their personal growth all the while ensuring business needs are met now and into the future.

Across our company, we embrace diversity and respect the dignity, privacy and personal rights of every employee.


At Galderma, we actively give our teams reasons to believe in our ambition to become the leading dermatology company in the world.

With us, you have the ultimate opportunity to gain new and challenging work experiences and create unparalleled, direct impact.

Job Description:


Reporting to Head of CMC Drug Development, the Manager of NCE Development and Maintenance, contributes to the New Chemical Entity (Oral and Topical) CMC Product Development plans; coordinating and designing with its team scientific studies from early development into confirmatory development, technology transfer up to registration and beyond with the legacy products maintenance.


Job responsibilities:

  • Organize the Small Molecule Development team to support short, mid and long term Galderma's strategy and develop a vision to make it a successful team (timelines, budget, resources, deliverables, culture)
  • Contribute to the NCE product development plan, with effective technical, innovative concepts and study designs supporting global product submissions with a minimum of review cycles
  • Set and manage relations with external partners (e.g. CDMO, Academic, Ingredient suppliers)
  • Review CMC and quality documents as needed (i.e. IND, IMPD, CTD)
  • Partner with various groups of the organization as appropriate (Clinical Development, Medical Affairs, Regulatory Affairs, Marketing, Manufacturing, Transverse activities, Portfolio, Research, Finance) to develop innovative product and support the various brands of the GBUs portfolios
  • Provide support to Operations, Industrial Property teams or any other partner to troubleshoot any technical issue (e.g. structural identification, counterfeited product investigation)
  • Contribute to Business Development activities by providing directly or via the Team scientific assessment in the context of external opportunities and divesting projects
  • Scout and benchmark cuttingedge and specific technologies in the field of NCE and ensure knowledge acquisition
Education and Experience Requirements

  • PhD in Pharmaceutical Sciences; Formulation, Analytical Sciences, Chemistry, Biotechnology, Pharmacist with at least 15+ years of relevant experience in Pharmaceutical Industry
  • Established track record of success with systemic and topical product developments from early development into confirmatory development, technology transfer up to registration and beyond with the legacy products maintenance
  • Indepth knowledge in developing innovative product according to international regulations
  • Demonstrated experience in setting and developing external partnerships: suppliers, CDMO, CRO, academic
  • Experience in NDA/CTD/BLA regulatory submissions
  • Excellent understanding of cGMP, Pharmacopeia, ICH guidance and applicable guidelines
  • Proven experience in critically reviewing scientific information and assessing the impact on the development strategy
  • Demonstrated effective leadership, project management, communication, interpersonal and negotiation skills
  • Ability to promote and manage changes
  • Demonstrated oral and written communication skills in multicultural settings (Fluent in English. French or Spanish is a plus)

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