Principal Research Scientist I/II Biologics Quality Control in Biologics Analytical R&D (m/f/d)

Your Qualifications:

• 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.

Your Tasks:

• 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.

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