Company Description About AbbVie 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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, (https://www.linkedin.com/company/abbvie/) Facebook, Instagram (https://www.instagram.com/abbvie/), X (https://twitter.com/abbvie) and YouTube. (https://www.youtube.com/user/AbbVie) 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? Youve come to the right place! Moving mountains together u2013 as Analytical Lead u2013 Protein Analytics in Early Analytical Development R&D (all genders) 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 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: Bacheloru2019s Degree in Science related field with 16 years of related work; Masteru2019s 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 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) u2013 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 u2013 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 u2013 we will discuss everything else with you in person. Have questions? Email Talentacquisition.de@abbvie.com u2013 We look forward to hearing from you! Additional Information AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.u202f Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html