Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

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)

AbbVie Biologics Analytical Research & Development (NBE 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 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 NBE 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 NBE Analytical R&D team and can offer exciting and rewarding career opportunities for these candidates.

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 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) 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.

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 corporate health management that offers comprehensive health and exercise programs

• with company social benefits

• with a wide range of career opportunities in an international organization

• with top-tier, attractive development opportunities

• with a strong international network

Multiple times, we have been globally recognized as a "Great Place to Work" and we are proud to provide our employees with the flexibility to maintain a healthy work-life balance. We take our impact on the environment and our communities seriously and therefore focus on giving something back on a regular basis. We are committed to equality, equity, diversity and inclusion (EED&I) – a commitment that is fundamental to us. This includes appreciating different perspectives, creating an inclusive culture and treating all employees with dignity and respect.

At AbbVie, your individual contributions count – help us move mountains together. Be a part of our success, grow with us and accomplish more than you could have imagined. Sounds like the perfect career opportunity for you? We look forward to receiving your application! All you need is a complete CV – we will discuss everything else with you in person.

Any questions? Feel free to email as at TalentAcquisition.de@abbvie.com – we look forward to hearing from you!

Additional Information

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.