AbbVie Analytical Research & Development (Analytical R&D) is a global analytical sciences organization responsible for all CMC analytical activities related to the development of AbbVie's pharmaceutical products. Our scope includes AbbVie's diverse pipeline of innovative small molecule and therapeutic biologic medicines and spans from the selection of Discovery candidate molecules through the transition of analytical methods and testing to commercial labs to support product launch. We are building a world-class team of scientists and leaders who will drive the advancement of industry-leading analytical capabilities and make meaningful contributions to advance AbbVie's pipeline of innovative medicines. Careers in AbbVie Analytical R&D provide unique opportunities to work with global and cross-functional teams to drive exceptional science and innovative product development strategies. We are looking for diverse candidates with strong scientific and leadership experience to join the AbbVie Analytical R&D team and can offer exciting and rewarding career opportunities for these candidates.
- You represent the NBE Analytical Function as single point of contact in global Product Development Strategy Teams and are responsible for the analytical development of biological assets in close collaboration with Formulation Lead, Device Lead and other development functions represented on the Product Development Strategy Team (eg. QA, CMC RA).
- Independently you conceive, execute, and communicate analytical development strategies to achieve CMC project goals appropriate for the development phase. You are accountable for the design and timely delivery of respective analytical work packages (e.g. stability and comparability studies) as appropriate to meet agreed upon CMC development objectives.
- You cover the analytical test method range necessary for the quality control and characterization of biological drug substances and drug products with experience in compendial, physico-chemcial and bioassay/ELISA test methods. Experience with antibody-drug conjugates is an advantage.
- You translate analytical project needs into defined work packages and liaise with ARD Outsourcing to place these work packages at Analytical Service Providers and lead scientific discussions regarding test protocols, test methods, validation plans, stability protocols, test method transfers and approve Analytical Service Provider documentation as appropriate.
- You take an active role in regulatory agency interactions (e.g. preparation of scientific advice meeting briefing books), respond to agency requests and participate in agency meetings (e.g. pre-approval inspections).
- You will create and author project level analytical documents e.g. plans for stability and comparability studies, analytical specifications, analytical risk assessments and target profiles, CMC sections in regulatory submissions (CTAs, INDs, MAAs and BLAs). You consolidate analytical test results into higher level summary reports.
- Furthermore, you actively engage analytical 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.
- You 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 analytical project needs into work packages and distribute these within the NBE analytical functional groups.
- You hold a University degree in a relevant life science discipline (e.g. chemistry, biochemistry, pharmacy) PhD + 6 years or M.S. + 12 years of experience in a GMP-regulated QC environment.
- You possess a comprehensive knowledge of protein analytics and bioassays in a regulated quality control environment and are versed in protein extended characterization.
- You have a thorough understanding of the major regulatory requirements (ICH, EMA, FDA).
- Due to previous work you are experienced in late stage biologics development, including MAA/BLA exposure. You had a significant role in at least one product marketing application.
- You are generally recognized as an established expert in your area of expertise (e.g. bioassay, quality control, protein characterization). As a global acting company, we presume excellent communication skills, including fluent English.
Travel: Yes, 10 % of the Time
Job Type: Experienced