Nbe Analytical Lead with Focus On Protein Toxins

vor 5 Monaten

Ludwigshafen am Rhein, Deutschland AbbVie Vollzeit

**Company Description**

**Job Description** 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? You’ve come to the right place

In our Pharmaceutical development department within Research and Development at the Ludwigshafen site, you will be working in a team of talented people and experienced experts toward developing tomorrow's products. In cutting-edge laboratories, you will be setting highest standards in the competitive field.

Moving mountains together - as **NBE Analytical Lead with focus on protein toxins (all genders) (permanent / part
- or fulltime)**

**Make your mark**:

- **
**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

**Qualifications** Qualifications**:
Bachelors Degree in Science or equivalent education and extensive, Typically, 14+ years of experience; Masters Degree in Science or equivalent education with typically 12+ years of experience; PhD with typically 6+ years of experience in area or scientific area of discipline (e.g. chemistry, biochemistry, pharmacy)
- 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

**Here's how we can move mountains together**:

- **
**with a diverse work environment where you can have a real impact
- with an open corporate culture
- with an attractive salary
- with an intensive onboarding process with a mentor at your side
- with flexible work models for a healthy work-life balance
- with a corporat

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