AbbVie Senior Scientist Analytical Development of Biologicals (m/w/d) in Ludwigshafen, Germany
Senior Scientist Analytical Development of Biologicals (m/w/d)
Germany, Rhinland-Palatinate, Ludwigshafen
Research & Development
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.
Your Tasks And Responsibilities:
Develops and aligns a global strategy for test method development and validation, stability studies, analytical control strategy, etc. within ARD and cross-functionally considering the global regulations and GMP requirements with focus on new biological entities (NBE) and chemical entities (NCE).
Manages effectively local/global interfaces (LU, US East and West Coasts and Lake County) and drives cross-functional alignment (DPD, Regulatory, QA, S&T, etc.). Contributes to global cross-functional initiatives to improve processes and facilitates their implementation.
Evaluates the regulatory landscape for new requirements and changes impacting the area of responsibility and ensures their implementation.
Who you are :
Degree in pharmaceutical sciences, chemistry, biochemistry, molecular biology, food sciences or related field, preferably with PhD.
Minimum 5 years of experience in the pharmaceutical industry with exposure to analytical development across all stages of development, including regulatory filings
Sound expertise in development of complex analytical methods and practical experience with test method validation preferably for NBEs
Experience with analytical areas relevant for the filing strategy of development programs (e.g. stability testing, analytical control strategy,).
Sound knowledge of global GMP requirements and regulations and experience with their implementation in a global ARD development strategy.
Innovation & Scientific Leadership:
Is up to date on regulatory expectations (guidelines, GxPs as appropriate) and translates these in locally and globally aligned strategy and executable approaches.
Drives/coordinates local and global initiatives to align and improve processes.
Adapts to changing environments and balances priorities within function.
Supports the utilization of appropriately risk based approaches to ensure project and internal/external budget success and to increase efficiency
Drives technological innovation and guides improvements to leverage operational excellence within function and in line with the ARD vision.
Serves as SME and consultant for ARD project teams.
Contributes to creating and establishing a new centralized function within AR&D
Builds strong relationships with peers to create and implement aligned local and global processes and strategies as it relates to area of responsibility.
Motivates and influences others to drive global alignment and process improvement.
Knows the business to influence long-range strategy.
Deals comfortable with uncertainty, ambiguity and risk to make decisions having mid-term impact. Ensures alignment with corporate/regulatory policies/standards.
Learns fast, grasps the essence and can change course quickly where indicated to manage and prioritize resources & timelines across a wide range of development programs/scientific initiatives within area of responsibility.
Get in touch:
Contact: Alexander Krüger (email@example.com)
Apply through our system (we need only a detailed CV)
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A fantastic opportunity to work in 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 online application.
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 active.
Job Type: Experienced
Job Level Code: IC