The job that makes possibilities real in patients' lives. And yours.

The job that helps you get ahead in life. Moving mountains together.

Welcome to AbbVie! As part of an international company with 48,000 employees worldwide and around 3,000 employees in Germany, you will have the opportunity of addressing some of tomorrows 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? Youve come to the right place!

Moving mountains together – as Principal Research Scientist I/II / Biologics Drug Product Lead (R&D) (all genders) (full-time, permanent)

Within R&D Biologics Drug Product Development Germany, the Early Strategic and Technical Development group is seeking an experienced scientist with expert knowledge in Biologics drug product development who aims at taking a lead in developing innovative and patient centric Biological products, turning science into medicines.

The scientific background of the incumbent should include formulation, manufacturing process development, container closure systems, quality risk management and analytical development. Solid experience with various molecule types, working in a global team and strategic as well as scientific thinking is a must. Experience with CMC regulatory submission documents and working in a GMP regulated environment is required. Experience working in a matrix leadership is beneficial, as well as analytical experience in e.g. quality control and characterization of biological drug products, and knowledge in device development..

Your tasks and responsibilities

• The candidate will serve as Biologics Drug Product Lead on global Product Development Strategy Teams that are tasked with the pharmaceutical development of pipeline biological drug products. The incumbent will represent the Biologics Drug Product Development Germany function and serve as single point of contact for the CMC Product Development Director (Product Development Strategy Team leader) for all Drug Product Development topics and will work closely with cross-functional subject matter experts from Discovery, analytical, and device development, Quality Assurance, CMC Regulatory Affairs, parental Product Development Science & Technology (Operations) and external partners
• You represent Biologics Drug Product Development Germany as single point of contact in global Product Development Strategy Teams and are responsible for the formulation, manufacturing process and container closure system development of early-stage biological assets up to clinical phase III. You work in close collaboration with Analytical Lead, Drug Substance Lead, Device Lead and other development functions represented on the Product Development Strategy Team (e.g. QA, CMC RA, pPDS&T/ late-stage development teams).
• You represent Biologics Drug Product Development Germany in project specific early-stage Development Sciences Core Teams connecting discovery with toxicology, DMPK and drug substance and drug product.
• You translate expert knowledge and project specifics into efficient and patient centric Drug Product development strategies. For this you establish, align, execute and communicate the Product Development strategies to achieve CMC project goals appropriate for the development phase.
• You are accountable for phase appropriate design and timely delivery of the respective Biologics Drug Product Development work packages to meet CMC development objectives.
• You will create project level Drug Product Development documents for Biologics e.g. QTPP, Formulation Declaration, control strategy documentation, CMC sections in regulatory submissions (CTAs, INDs). You consolidate project results/outcome into higher level summary reports.
• You take an active role in regulatory agency interactions (e.g. preparation of scientific advice meeting briefing books, responses to agency requests).
• Furthermore, you actively engage CMC developability, formulation, manufacturing process, container closure system, and device experts locally and globally in scientific, project-related topics, issues and discussions and collaborate with cross-functional SMEs to solve technical issues that arise during development. This could also include drug product development project leadership of partially and/or fully outsourced projects to external partners.
• You proactively communicate project strategy, key issues, and risks to the Product Development Strategy Team, to functional management and SMEs and present complex technical topics to the development team and management.
• In addition, you plan personnel (FTE) and budgetary resource requirements for assigned projects and translate project needs into work packages and distribute these within the NBE Drug Product Development Germany functional groups.
• You engage in global initiatives around drug product development.