AbbVie Biologics Analytical Lead (m/f/d) in Ludwigshafen, Germany
Biologics Analytical Lead (m/f/d)
Germany, Rhinland-Palatinate, Ludwigshafen
Research & Development
AbbVie is seeking a seasoned analytical scientist with expert experience in the quality control and characterization of biological drug products to serve as Analytical Lead on global CMC teams that are charged with the pharmaceutical development of pipeline biological drug products. The incumbent will represent the analytical function and serve as single point of contact for the CMC Product Development Director (CMC team leader) for all analytical topics and will work closely with cross-functional subject matter experts from formulation, manufacturing process and device development, Quality Assurance and CMC Regulatory Affairs. Experience with late-stage development products and/or product CMC life cycle management is highly advantageous.
Major Responsibilities of the Analytical Lead
You represent the NBE Analytical Function as SME in global CMC project teams and are responsible for the analytical control strategy for a development asset in close collaboration with Formulation Lead, Device Lead and other development functions represented on the CMC team (eg., QA, CMC RA).
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.
You design project specific plans for stability and comparability studies as appropriate and respond to agency requests and participate in agency meetings (eg pre-approval inspections).
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 CMC team, to functional management and SMEs and present complex technical topics to teh CMC team and management.
In addition you plan personnel FTE and budgetary resource requirements for assigned projects in collaboration and translate analytical project needs into work packages and distribute these within the NBE analytical functional groups.
Your AbbVie talent:
You hold a University degree in a relevant life science discipline (e.g. chemistry, biochemistry, pharmacy) PhD + 5-10 years or M.S. + 10-15 years of experience in a GMP-regulated QC environment.
You possess a comprehensive knowledge about protein analytics in quality control and 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, preferably with MAA/BLA exposure.
As a global acting company we presume excellent communication skills, including fluent English.
We offer you:
An opportunity to work in a world-class team.
A supportive environment that allows you to focus on your role and tailor your work to your individual needs, including flexible work models, multiple benefits, and comprehensive health and sports programs.
Attractive compensation and company benefits, including our excellent occupational health management system, which is one of the best in Germany.
We are looking forward to your application. Please provide information about your salary expectations and possible start date in your motivation letter.
An equal opportunity employer. AbbVie welcomes and encourages diversity in our workforce.
Learn more about AbbVie Deutschland at www.abbvie.de. Visit www.abbvie-care.de for more information about the therapeutic areas in which we’re activ e.
Travel: Yes, 5 % of the Time
Job Type: Experienced