Position: Biochemist - Analytical Development, Genetherapy (m/f/d)
Location: Bad Homburg vor der Höhe

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients’ needs by using the latest technologies, we develop and deliver innovative therapies that treat coagulation disorders, primary immune deficiencies, hereditary angioedema, respiratory disease, and neurological disorders. The company’s products are also used in cardiac surgery, burn treatment and to prevent hemolytic disease of the newborn.

Visit to learn more about our current job opportunities so you can begin to build your promising future.

For our Recombinant and Gene therapy Product Development department we are looking for a
• Scientist Analytical Development (m/f/x) - R-199305

(Fulltime / permanent / tariff)

Join the Bioanalytical Development group - an enthusiastic team within Bioprocess Development at CSL Behring Innovation GmbH in Marburg... (Germany). This role focuses on development of state-of-the-art analytical assays, as well as early-stage method validation and analytical technology transfer to drive the process development for our innovative R&D product pipeline.

The successful candidate has profound scientific expertise in biochemistry and protein analytics, with broad hands-on expertise in bioanalytical method development and analytical instrumentation. As a strong team player, he/she will also be working on establishment of high throughput automated assay formats and playing a key role as analytical subject-matter expert in driving innovative, smart bioanalytical workflows.

We are looking for an individual open for challenges and ideas with strong analytical problem-solving skills. Being proficient and diligent in interpreting of complex scientific data and compilation of scientific documents is as relevant as being a strong team player closely working in cross-functional, international project teams.

Main

Responsibilities and

Accountabilities
• Accountable for development of state-of-the-art, innovative and compliant analytical methods for protein-based biopharmaceuticals in early-stage product development (method portfolio includes: immunological assays, biochemical activity/potency assays, protein glyco / PTM assays, spectroscopic (UV / VIS / fluorescence) assays, capillary electrophoresis (CE, CZE, cIEF) and HPLC-based methods, DNA technologies, impurity analysis, compendial assays)
• Early-stage hands-on assay development and pre-qualification of (release) methods, setting up standard operating procedures, control strategies, method performance strategies
• Technical transfer to and coordination with (external) partner laboratories, drive analytical lifecycle management for advanced product development stages
• Driving innovative solutions towards lean and efficient analytical workflows using state-of-the-art instrumentation, digital tools and HT automated systems to foster fast track and interconnected product development
• Accountable for data review, reporting and presentation, communicate (written, oral in English) with customers, project-teams and external partners
• Provide analytical expertise as subject-matter expert regarding analysis of CQAs and PTMs relevant for recombinant proteins, interpret complex scientific data, lead analytical root-cause investigations
• Compilation of scientific documents in English (e. g. analytical development reports and (pre-) qualification plans and reports, documentation required for regulatory submission)
• Take on the role of analytical representative in product development project (if required)
• Supervision of apprentices and interns. Perform routine sample testing (if required), lab documentation and safety tasks. Support general laboratory upkeep, such as coordination of equipment maintenance, ordering of consumables
• Advanced scientific background in protein biochemistry, preferably with strong bioanalytical focus
• Sound knowledge of analytical Quality by Design principles and quality guidelines relevant for assay development
• Proven expertise in a wide spectrum of bioanalytical assays and methods, as well as hands-on experience operating complex analytical instrumentation including automated systems such as liquid handling stations
• Proficient in principles of method (pre-) qualification and approaches for analytical Innovation
• Proficient in advanced statistical & bioanalytical software (e. g. PLA, JMP, Fusion QbD)
• Proficient in compilation of standard operating procedures, comprehensive scientific reports, preferably documentation required for regulatory submission
• Experienced with design of experiments (DoE), digital automation tools and scripting
• Experienced in interacting with international project teams, analytical technology transfer
• Solid in analytical problem-solving, fast learner, resilient towards new challenges
• Interdisciplinary way of thinking and empowered working style allowing to act in teams with the right sense for quality, agility and accountability
• Well organized and efficient working mode coupled with the ability to prioritize and delegate…
Bad Homburg Germany

Salary Criteria