CMC Project Leader - The Voice of CMC
Ferring Pharmaceuticals A/S
Do you want to apply your CMC Project Leadership skills in an entrepreneurial and open work environment, where your contributions will be valuable and make a difference, and your voice will be heard? Then we have just the opportunity for you! Your new team The CMC Program Leadership Department is a high performing team of proactive, bright and very dedicated colleagues, who always strive for excellence. We are driven to continuously innovate and create value in all we do - building families and helping people live better lives. The CMC Program Leadership is part of the Global Pharmaceutical R&D, which is accountable for end-to-end development of the product, and responsible for development programs according to the Ferring R&D portfolio across the global organization. The job As our CMC PL, you will lead the development of the CMC strategy for the Ferring R&D programs to enable execution of activities throughout a product's lifecycle. In this role, you will be the voice of CMC/GPRD in global project teams, having the final decision-making responsibility.
The CMC PL will work with team members across functions, vendors, contract laboratories, ventures, and other internal and external partners.
Reporting to the Senior Director for CMC Program Leadership, the CMC Project Leader is accountable for developing and delivering upon the Integrated Product Development Plan and drive alignment and achievement of CMC development and manufacturing milestones in accordance with project timelines. Responsibilities Your essential responsibilities include but are not limited to:
Define and implement CMC development strategy and drive alignment with functional leaders
Driving, following-up and maintaining the end-to-end CMC project scope, project plan and objectives to ensure clarity of deliverables, quality and timing, budget and risks according to guidelines and development tools, including review of relevant documentation.
Effectively communicating, and presenting the CMC project e.g., at governance boards, authorities.
Align CMC team on content and strategy and create synergy in activities taking place at multiple sites; including external manufacturing campaigns, process/analytical development, functional characterization, release testing, comparability campaigns, stability studies, regulatory filings and other CMC related activities
Track, compile, review and ensure timely delivery of documents in support to regulatory filings and response to module 3
Leading, coordinating and assessing the CMC part in the due diligence process.
Qualifications We expect the ideal candidate to have:
Master’s degree in a natural scientific discipline.
Solid experience in leading projects in CMC areas in a pharmaceutical or biotechnology environment
Demonstrated knowledge of the CMC development process, including an understanding of the interdependencies of functional groups.
Strong communication skills in English - fluent in speaking and writing
Contact and application
Please send your application and CV in English.
Please note that we review applications on an on-going basis and close the process when we find the right match – the sooner you apply the better are your chances.
Ferring Pharmaceuticals is a leader in reproductive medicine and women’s health, and in specialty areas within gastroenterology and urology. At Ferring International PharmaScience Center (IPC) in Copenhagen we are nearly 600 people, primarily scientists and specialists working to break new land to help people live better lives. We focus our R&D efforts on peptide-based drugs and biotechnology derived medicines.
As a privately-owned company we benefit from the privilege to think and work with a long-term horizon. You will experience the same freedom in your search for new solutions. Your desire to innovate and explore will contribute to fulfilling our ambition of becoming the world’s leading company within reproductive medicine and women’s health. If you need help, you will find it. If you want challenges, they are right in front of you. If you are looking for freedom to find your own way, you are trusted to do so. If you want to make a mark in the world for the better, you feel just like the rest of us. Read more at ferring.com
Location:
Ferring Denmark
