Drug Product Lead (all genders) - permanent, fulltime

Challenging work. Global impact. Every day. Welcome to AbbVie! As part of an international company with 50,000 employees worldwide and around 3,000 employees in Germany, you will have the opportunity of addressing some of tomorrow's unmet medical needs in close collaboration with your colleagues. Are you passionate about improving global health care? Do you want to contribute to improving patients' quality of life through your expertise? In a challenging work environment that offers opportunities of developing and increasing your own skills? You've come to the right place!

As a Drug Product Lead you will lead and represent the Drug Product (DP) team for a product and you will be responsible for defining and executing the activities of drug product development, lifecycle management, and the technical-scientific support of the commercial production according to the latest state of science and technology, while considering regulatory requirements for the manufacturing of pharmaceuticals in parenteral drug product development.

Job Description

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

Qualifications

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;