NBE Biologics Technical Lead Drug Product Development (all genders) (permanent / full-time)

Stellenbeschreibung

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!

Moving mountains together as NBE Biologics Technical Lead Drug Product Development (all genders) (permanent / full-time)

AbbVie NBE Drug Product Development (DPD) Germany is a global organization responsible for all DPD CMC activities related to the development of AbbVie's pharmaceutical products.

Our scope includes AbbVie's diverse pipeline of therapeutic biologic medicines and spans from the selection of Discovery candidate molecules through product presentations for clinical Phase III.

We are building a world-class team of scientists and leaders who will drive the advancement of industry-leading formulation capabilities and make meaningful contributions to advance AbbVie's pipeline of innovative medicines.

Careers in AbbVie NBE Drug Product Development Germany 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 Drug Product Development Germany team and can offer exciting and rewarding career opportunities for these candidates.

AbbVie is seeking an experienced scientist with expert knowledge in formulation, manufacturing process development, container closure systems and quality risk management.

Solid experience with various molecule types and working in a global team is required. Experience with CMC regulatory submission documents is required.

Analytical experience in e.g. quality control and characterization of biological drug products is beneficial, as well as experience of working in a GMP regulated environment.

Knowledge in device development is beneficial.

The candidate will serve as Biologics Technical Lead on global Product Development Strategy Teams that are tasked with the pharmaceutical development of pipeline biological drug products.

The incumbent will represent the NBE 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 analytical, and device development, Quality Assurance, CMC Regulatory Affairs and Product Development Science and Technology (Operations).

Responsibilities

• You represent NBE 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 biological assets in close collaboration with Analytical Lead, Device Lead and other development functions represented on the Product Development Strategy Team (e.g. QA, CMC RA, PDSnT)
• Independently you conceive, execute, and communicate Drug Product Development strategies to achieve CMC project goals appropriate for the development phase
• You are accountable for the design and timely delivery of respective Drug Product Development work packages as appropriate to meet agreed upon CMC development objectives
• You will create project level Drug Product Development documents 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 formulation, manufacturing process and container closure system 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 project needs into work packages and distribute these within the NBE Drug Product Development Germany functional groups

Qualifikationen

You hold a University degree in a relevant life science discipline (e.g. chemistry, biochemistry, pharmacy) PhD + 4 years or M.

S. + 10 years of experience in minimum in two of the following disciplines : formulation, manufacturing process, container closure system, analytical development and quality risk management

• You possess a comprehensive knowledge in drug product development of a biological entity, minimally in the areas of formulation, manufacturing process, CCS development and quality risk management
• You gained experience in the development of biological therapeutics, specifically antibodies and / or their derivatives
• You have a thorough understanding of the major regulatory requirements (ICH, EMA, FDA)
• You have experience with novel modality projects
• You are generally recognized as an established expert in your area of expertise (e.g. formulation, manufacturing process, container closure system development)
• As a global acting company, we presume excellent communication skills, including fluent English
• You have excellent interpersonal skills and are able to lead and influence in a matrix environment
• You feel comfortable dealing with ambiguity and are able to make decisions taking appropriate risk

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 [email protected] we look forward to hearing from you!

Zusätzliche Informationen

Nur gemeinsam können wir das Beste für Patienten erreichen. Daher setzen wir bei AbbVie auf Chancengleichheit, Vielfalt & Inklusion.

Wir gestalten ein Arbeitsumfeld, in dem alle Mitarbeiter ihr Potenzial entfalten können unabhängig von Geschlecht, Herkunft, Religion, sexueller Orientierung oder anderen Vielfaltsdimensionen.

Doch für uns bedeutet Vielfalt mehr als nur offensichtliche Unterschiede zu berücksichtigen : Sie bezieht sich auch auf unterschiedliche Ausbildungshintergründe, Fachkenntnisse, Persönlichkeitstypen, Denkweisen und Lebenserfahrungen.