Drug Product Lead (all genders) - permanent, fulltime

Make an impact:

• Provide technical leadership to cross-functional teams during Drug Product development, commercial launch or trouble shooting of established processes and site transfers/scale-ups
• Lead and represent the Drug Product (DP) team for a late-stage development and/ or a commercial product
• Drive Site Transfers to commercial DP manufacturing sites and process validation activities (Demo/PPQ)
• 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.
• Create project level documents e.g. QTPP, Formulation Declaration, control strategy documentation
• Review and approve of GMP-compliant and regulatory documents (such as IMPD, IND, CTD for clinical trials, and BLA, NDA, PAS for market application 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, Biologist or comparable, preferably with PhD
• 8+ years of experience in relevant areas of parenteral Drug Product Development and/or commercial support
• Demonstrated track record of advancing complex parenteral drug product programs through late-stage development, with recognized technical depth and scientific leadership
• Strong experience leading technology transfer from R&D to Operations is highly desirable
• Extensive late-stage drug product development and commercial support experience is preferred
• Deep understanding of parenteral drug product development, including formulation, process development, manufacturability, and product lifecycle considerations
• Ability to lead multiple concurrent priorities in a fast-paced, collaborative environment; strong expertise in global CMC drug development, strategic planning, and project execution
• Experience supporting clinical and regulatory dossier preparation and market authorization submissions, including IMPD, IND, CTD, BLA, NDA, and PAS
• Experience in a cGMP-regulated environment, with solid knowledge of applicable international regulatory and quality requirements, particularly those in the US and EU
• Strong leadership capability with a proven ability to influence and collaborate effectively across direct and cross-functional teams in a matrix environment

Here's how we can move mountains together:

• with a diverse work environment where you can have a real impact
• with an open corporate culture
• with 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 Abb Vie, 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 Talent Acquisition.de@abbvie.com – we look forward to hearing from you!

Abb Vie 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.