About this role
In detail you will:
Lead and represent the Drug Product (DP) team for a late-stage development and/ or a commercial product.Drive Tech Transfers to commercial DP manufacturing sites.Provide technical leadership in exception and change management.Represent manufacturing, CCS and Formulation aspects in the PDS&T CMC Team.Develop, manage and drive execution of global initiatives to improve biologics CMC drug product development and commercial support strategies.Review and approve GMP-compliant and regulatory documents (such as IMPD, IND, CTD for clinical trials, and BLA, NDA, PAS for market submissions).Communicate actively project strategies, key issues, and risks to the PDS&T CMC- Team, to functional management and SMEs as well as present complex technical topics to the development team and management. This is how you make a difference:
Pharmacist, Chemist, Biochemist, Chemical Engineer or comparable, preferably with PhD8+ years of experience in relevant areas of parenteral Drug Products or equivalentProven track-record of advanced technical/scientific achievements such as:Practical experience with process transfers from R&D to Operations is desirable.Must be capable of working in a fast-paced, collaborative environment overseeing multiple concurrent projects. Thorough understanding of Global CMC drug development, strong project management skills, and long-term planning skills.Experienced working in a cGMP-regulated environment, including knowledge of international relevant (especially US/EU) regulatory and quality requirements and standardsStrong leadership skills: Proven track-record in successful direct or cross-functional people management . Effective working in matrix organisation Here's how we can move mountains together:
with a diverse work environment where you can have a real impact with an open corporate culturewith an attractive salary with an intensive onboarding process with a mentor at your side with flexible work models for a healthy work-life balance with a corporate health management that offers comprehensive health and exercise programs with company social benefits with a wide range of career opportunities in an international organization with top-tier, attractive development opportunities with a strong international network
Multiple times, we have been globally recognized as a "Great Place to Work" and we are proud to provide our employees with the flexibility to maintain a healthy work-life balance. We take our impact on the environment and our communities seriously and therefore focus on giving something back on a regular basis. We are committed to equality, equity, diversity and inclusion (EED&I) – a commitment that is fundamental to us. This includes appreciating different perspectives, creating an inclusive culture and treating all employees with dignity and respect.
At AbbVie, your individual contributions count – help us move mountains together. Be a part of our success, grow with us and accomplish more than you could have imagined. Sounds like the perfect career opportunity for you? We look forward to receiving your application! All you need is a complete CV – we will discuss everything else with you in person.
Any questions? Feel free to email as at [email protected] – we look forward to hearing from you!
AbbVie setzt sich für Chancengleichheit ein und verpflichtet sich, mit Integrität zu arbeiten, Innovationen voranzutreiben, Leben zu verändern und unserer Gemeinschaft zu dienen. Chancengleichheit bei Arbeitgeber/Veteranen/Behinderten.