Analytical Lead – Protein Analytics in Early Analytical Development R&D (all genders) (full- or parttime, permanent)

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 48000 employees worldwide and around 3000 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 as Analytical Lead 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: Bachelors Degree in Science related field with 16 years of related work; Masters 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

Heres 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.

Have questions Email We look forward to hearing from you! 

Zusätzliche Informationen :

AbbVie setzt sich für Chancengleichheit ein und verpflichtet sich mit Integrität zu arbeiten Innovationen voranzutreiben Leben zu verändern und unserer Gemeinschaft zu dienen. Chancengleichheit bei Arbeitgeber/Veteranen/Behinderten.

Remote Work :

No

Employment Type :

Full-time