Drug Product Lead

AbbVie

Ludwigshafen, Germany

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; 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.