Principal Research Scientist I/II Biologics Quality Control in Biologics Analytical R&D

AbbVie

Ludwigshafen, Germany

The Principal Scientist I/II will be an integral part of the Analytical Innovation and Mass Spectrometry Team in the Bio CMC division. The role involves supporting analytical aspects of biologics products with a focus on advancing AbbVie’s early-stage clinical programs. This position calls for an individual with a strong technical analytical background, demonstrated leadership skills and the ability to effectively communicate and work cross-functionally.

Make your mark

Lead and mentor scientists specializing in separation-based assays including HPLC and capillary electrophoresis for sample testing to support biologics mab and DS process development, characterization, validation as well as GMP manufacturing investigation activities.
Serve as analytical representative in AbbVie's CMC teams, supporting early-stage biologics pipeline assets. Balance stakeholder expectations to ensure effective collaboration.
Serve as the subject matter expert for analytical test methods, providing expertise and support for method development, execution, and troubleshooting.
Evaluate and select effective analytical technologies and methods to meet program needs. Support automation and development of high-throughput analytical methods and drive timely delivery of high-quality testing results.
Participate in the preparation and review of technical documents for early-stage programs. Take responsibility for analytical test methods, their development and validation, test method transfer to internal and external partners, as well as perform batch release activities.
Collaborate with other analytical teams in R&D and PDS&T on program transition, workflow and program strategic alignment. Provide guidance to peers on project management, analytical strategy, and technical skills related to separation techniques.
Communicate project data, issues and risks to relevant teams. Promote proactive risk resolution within and across functional areas to advance project objectives.
Demonstrate scientific excellence, advance science and innovation. Implement novel analytical techniques to enhance method robustness and expand analytical capabilities.

Qualifications

This is how you make a difference:

PhD in chemistry, biology, biochemistry, chemical engineering, or related technical discipline. Minimum of 8+ years (PhD) of professional experience working in biotech/pharmaceutical setting.
Proven experience managing and leading analytical development and QC activities for biologic development, including mAbs, multi-specifics, antibody-drug conjugates, and fusion proteins.
Experience in the role of Head of Quality Control (HQC) according to § 12 AMWHV is a plus.
Expertise in protein and impurity analysis techniques such as HPLC, capillary electrophoresis, and other relevant methods. Experience with mass spectrometry and ELISA is a plus.
Skilled in technical writing including experience in authoring, reviewing documents with regulatory impact.
Strong people leadership skills and demonstrated ability to foster an engaging, inclusive and collaborative team environment.
Excellent communication and interpersonal skills, effectively managing relationships to enhance team decision-making.
Ability to work effectively across functions, anticipating and addressing overall program development needs.
Ability to quickly comprehend and adapt to new situations, with an open mindset and can-do attitude, demonstrating agility where necessary to address evolving project needs.
Ability to think critically and demonstrate troubleshooting and problem-solving skills.
Ability to lead and manage multiple projects of significant scope and complexity, while meeting all deliverables and timelines.
An independent, self-motivated, proactive individual who thrives in a fast-paced team environment.