Biologics Drug Product Lead (R&D) (all genders) (full-time, 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 Principal Research Scientist I / II / Biologics Drug Product Lead (R&D) (all genders) (full-time permanent)

Within R&D Biologics Drug Product Development Germany the Early Strategic and Technical Development group is seeking an experienced scientist with expert knowledge in Biologics drug product development who aims at taking a lead in developing innovative and patient centric Biological products turning science into medicines.

The scientific background of the incumbent should include formulation manufacturing process development container closure systems quality risk management and analytical development. Solid experience with various molecule types working in a global team and strategic as well as scientific thinking is a must. Experience with CMC regulatory submission documents and working in a GMP regulated environment is required. Experience working in a matrix leadership is beneficial as well as analytical experience in e.g. quality control and characterization of biological drug products and knowledge in device development..

Your tasks and responsibilities

• The candidate will serve as Biologics Drug Product Lead on global Product Development Strategy Teams that are tasked with the pharmaceutical development of pipeline biological drug products. The incumbent will represent the Biologics Drug Product Development Germany function and serve as single point of contact for the CMC Product Development Director (Product Development Strategy Team leader) for all Drug Product Development topics and will work closely with cross-functional subject matter experts from Discovery analytical and device development Quality Assurance CMC Regulatory Affairs parental Product Development Science & Technology (Operations) and external partners
• You represent Biologics Drug Product Development Germany as single point of contact in global Product Development Strategy Teams and are responsible for the formulation manufacturing process and container closure system development of early-stage biological assets up to clinical phase III. You work in close collaboration with Analytical Lead Drug Substance Lead Device Lead and other development functions represented on the Product Development Strategy Team (e.g. QA CMC RA pPDS&T / late-stage development teams).
• You represent Biologics Drug Product Development Germany in project specific early-stage Development Sciences Core Teams connecting discovery with toxicology DMPK and drug substance and drug product.
• You translate expert knowledge and project specifics into efficient and patient centric Drug Product development strategies. For this you establish align execute and communicate the Product Development strategies to achieve CMC project goals appropriate for the development phase.
• You are accountable for phase appropriate design and timely delivery of the respective Biologics Drug Product Development work packages to meet CMC development objectives.
• You will create project level Drug Product Development documents for Biologics e.g. QTPP Formulation Declaration control strategy documentation CMC sections in regulatory submissions (CTAs INDs). You consolidate project results / outcome into higher level summary reports.
• You take an active role in regulatory agency interactions (e.g. preparation of scientific advice meeting briefing books responses to agency requests).
• Furthermore you actively engage CMC developability formulation manufacturing process container closure system and device 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. This could also include drug product development project leadership of partially and / or fully outsourced projects to external partners.
• You proactively 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 project needs into work packages and distribute these within the NBE Drug Product Development Germany functional groups.
• You engage in global initiatives around drug product development.

Qualifications :

Heres how we can move mountains together

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

Key Skills

Laboratory Experience,Vendor Management,Design Controls,C / C++,FDA Regulations,Intellectual Property Law,ISO 13485,Research Experience,SolidWorks,Research & Development,Internet Of Things,Product Development

Experience : years

Vacancy : 1