CMC Project Lead, Synthetics
- The CMC Project Leader leads a cross-functional CMC team with representatives from CMC Development, Manufacturing and Supply, Quality, Dossiers, Regulatory, Demand and Supply, ...
- He/she creates with the CMC team a strategic and integrated CMC development plan based on global project objectives ensuring alignment with base case and accelerated plans and exploring opportunities for acceleration.
- He/she coordinates the execution of the development plans aligned with the CMC stage gate deliverables in a timely manner.
- He/she represents CMC as a core team member in the Global Project Team, contributing to the program strategy, providing consolidated recommendations to the Global Project Team and piloting /executing the appropriate actions within the CMC team to achieve the project goals.
- He/she implement the R&D/M&S governance for Synthetics projects and present the deliverables to the governance bodies at the different milestones for endorsement.
- He/she ensures that the project development follows actual standards and define the Quality Target Product Profile (QTPP) and product development targets. He/she is accountable for the timing and the quality of the CMC contributions to pre-clinical, clinical and validation (DS/DP), and CMC elements for regulatory submissions and consultations.
- He/she evaluates the CMC risks and proactively implement mitigation plans, and ensure appropriate escalation to Senior Management (e.g. Sponsor & Global Management as needed) and Global Project Team (Project Direction). He/she timely alert decision makers and stakeholders on project strategy and risks that can impact critical program timelines, resource planning or the budget. In case of scientific/technical issues coordinate corrective measures across functions in cooperation with local department heads & global functions as needed. He/she owns the communication of project specific CMC related topics and ensure appropriate engagement of functional leaders and key stake holders.
- PhD, MS, or other equivalent level advanced degree in a scientific or engineering discipline. One of the areas of drug development (e.g. pharmaceutical development, chemistry, ...) is preferred.
- In depth and very good knowledge in pharmaceutical development is mandatory.
- 10 years professional experience in CMC development is required.
- Strong expertise in CMC development, with proven experience
- Comprehensive scientific background in chemistry and/or pharmacy.
- Experience in project management.
- Experience and understanding of current Pharmaceutical environment including the economic and regulatory challenges.
- Experienced in working in cross functional project teams and in complex environment (e.g., activities across different sites),
- Fluent in English.
- Leadership capabilities, strong team spirit
- Management of transversal and cross-cultural teams
- Capacity to coordinate several activities and stakeholders, good communication skills, experience in stakeholder management and networking.
- Ability to manage complexity working in a fast paced environment, to operate in matrix organizations as well as in Alliance environments
- Ability to provide focused communication to Senior Management dealing with critical aspects and risks of the project
- Influencing and negotiation skills to build solutions and partnership.
- Objectives and deliverables / results oriented.
- Take responsibility for decisions and be accountable for the results.
- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
#LI-SA
#LI-Onsite #vhd All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
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