Analytical Lead - Protein Analytics in Early Analytical Development R&D

Analytical Lead - Protein Analytics in Early Analytical Development R&D

AbbVie

Ludwigshafen, Germany

Job Description

AbbVie is seeking a seasoned analytical scientist with expert experience in the quality & control strategy and characterization of biological drug products to serve as Analytical Lead on global Product Development Strategy 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 (Product Development Strategy Team leader) and external partners 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.

Your tasks and responsibilities:

• You represent the Early Bio CMC Analytical Function as single point of contact in global Product Development Strategy Teams and are responsible for the analytical development and analytical control strategy 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 lead 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-chemical and bioassay/ELISA test methods.
• You take an active and guided 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 take responsibility for programs with external partners in terms of analytical control strategy, analytical program timelines, data reporting and evaluation.
• 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 (INDs). 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

Qualifications

• Principal Research Scientist I: BS or equivalent education and extensive, Typically, 14+ years of experience; MS or equivalent education with typically 12+ years of experience; PhD with typically 6+ years of experience in area or scientific area of discipline.
• Principal Research Scientist II: Bachelor’s Degree in Science related field with 16 years of related work; Master’s Degree Science or PharmD with 14 years of related work; PhD in Science or related field with 8 years of related work experience.
• 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 gained experience in the analytical development of proteins and antibodies and/or their derivatives
• You have a thorough understanding of the major regulatory requirements (ICH, EMA, FDA)
• You have experience in communication and work with external partners such as cooperations as well as external laboratories
• Due to previous work, you are experienced in early stage biologic development, including IND exposure
• As a global acting company, we presume excellent communication skills, including fluent English