CMC-Leader for NCE drug development projects (all genders)

Posté 20 déc. 2021

Darmstadt, Hessen - Germany

Demander un identifiant 235922

Détails

 

A career at our company is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

 

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

 


Your Role:

 

As CMC-Leader you are responsible to lead and drive all Chemistry, Manufacturing and Control (CMC) activities for your assigned global NCE drug development projects. As leader of a cross-functional CMC-Team of technical experts you develop and are accountable for the global CMC development strategy from preclinical development towards initial MAA/NDA submission and product launch preparation. Within the global Program Teams and towards our key stakeholders (Quality, Global Manufacturing, Regulatory, CMOs and various internal and external functions depending on the project scope and status collaboration with external development partners) you are representing the Chemical & Pharmaceutical Development (CPD) function.

As CMC-Leader you are responsible to translate the global program strategy and objectives into a suitable CMC project plan and activities, to perform project planning and tracking, to manage the respective project objectives and to lead supply planning. You contribute to strategic global development plans and reports as well as risk and gap assessments on the global program team level and you ensure seamless transition of products into the commercial organization. Furthermore, you drive CPD input into global initiatives, leading strategic initiative within CPD or you perform an expert assessment of in-and out licensing projects for business development (Due Diligence).

 

Who you are:

 

  • University degree in pharmacy or another life science or related discipline, Ph.D. beneficial
  • Broad professional project-related experience in pharmaceutical development, manufacture, control, synthesis and/or CMC dossier creation for at least 5 years.
  • Demonstrated the growing ability to lead, engage and manage teams and to inspire stakeholders to achieve strategic development and implementation goals.
  • Good understanding of drug development, including knowledge of interfaces and interdependencies with other functions
  • Track record in providing technical and project management expertise in project teams and/or strategic initiatives.
  • Excellent understanding of quality and regulatory requirements, industry standards, and industry best practices for CMC development.
  • Capability to lead cross-functional matrix teams with measurable success
  • Ability to build strong professional relationships across the organization.
  • Excellent English communication plus any other European language (preferably).

 

Position can be based in EMEA or US region.


 

What we offer:  With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

 

Curious? Apply and find more information at https://jobs.vibrantm.com

 

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