Nbe Analytical Lead

vor 2 Wochen

Ludwigshafen am Rhein, Deutschland ABBVIE Vollzeit

A job where your ideas make a difference? We Offer That.
A job that makes a difference to our patients' lives? We Offer That.
A career where you can shape the future every day? We Offer That.

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 to work closely with us to address the health challenges of tomorrow. Do you have a passion for improving health care around the world and for using your expertise to improve patients' quality of life? In a challenging work environment that allows you to broaden and develop your own skills? You’ve found the right place

Further develop your expertise and join our team as

NBE Analytical Lead (all genders)

Make an impact:
This means:

- 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-chemical and bioassay/ELISA test methods. Experience with highly potent protein toxins is highly desired..
- You translate analytical project needs into defined work packages and liaise with ARD Outsourcing to place these work packages at Analytical Service Providers.
- 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.

This is how you can make a difference:

- You hold a University degree in a relevant life science discipline (e.g. chemistry, biochemistry, pharmacy) PhD + 6-8 years or M.S. + 12-14 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 gained experience in the analytical development of proteins, specifically protein toxins and antibodies and/or their derivatives.
- 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 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.

What we offer you:

- a diverse area of work where you can make a real difference
- an open company culture
- attractive remuneration
- intensive onboarding by a mentor
- flexible work models for a healthy work-life balance
- corporate health management with comprehensive health and exercise programs
- corporate social benefits
- diverse career options in an international organization
- high-level, attractive career development opportunities
- a strong international network

At AbbVie, your individual contributions count - help us achieve more together. Be a part of it and grow with us - go above and beyond

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