Drug Product Lead

AbbVie

Drug Product Lead at AbbVie managing parenteral drug product development and commercial support. Provide technical leadership and oversee global initiatives in a dynamic environment.

Posted 5/27/2026full-timeRemote • 🇩🇪 GermanySeniorWebsite

About the role

Key responsibilities & impact

Provide technical leadership to cross-functional teams during Drug Product development
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

Requirements

What you’ll need

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
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
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

Benefits

Comp & perks

flexible work models for a healthy work-life balance
attractive salary
intensive onboarding process with a mentor
corporate health management offering comprehensive health and exercise programs
company social benefits
wide range of career opportunities in an international organization
top-tier, attractive development opportunities
strong international network

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Drug Product developmentprocess validationGMP-compliant documentationformulation developmenttechnology transferproject executionregulatory dossier preparationparenteral drug product developmentstrategic planningproduct lifecycle management

Soft Skills

leadershipcollaborationcommunicationproject managementproblem-solvinginfluencingorganizational skillsability to manage multiple prioritiesadaptabilityteamwork

Certifications

PhDPharmacistChemistBiochemistBiologist