Drug Product Lead (all genders) - permanent fulltime

Overview

Joining our PDS&T organization as Drug Product Lead you will lead and represent the Drug Product (DP) team for a product and 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.

Responsibilities

• 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.

Qualifications

• Pharmacist, Chemist, Biochemist, Chemical Engineer or comparable, preferably with PhD.
• 8+ years of experience in relevant areas of parenteral Drug Products or equivalent.
• Proven 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 standards.
• Strong leadership skills: Proven track‑record in successful direct or cross‑functional people management. Effective working in matrix organisation.

Benefits

• 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 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

Equal Opportunity

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.