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SUSUSONITY

Senior Assay Development Scientist(m/w/x)

Darmstadt
Full-time, Part-timeOn-siteSenior

Method development, validation, and testing transfer for pharmaceutical products. GMP knowledge and laboratory techniques expertise required. Guidance of Associate Scientists and study managers.

Requirements

  • Academic studies in scientific discipline (e.g., Analytical Chemistry, Chemistry, Biology)
  • Board working knowledge of field and relevant laboratory practices, techniques, equipment, materials, and mathematical calculations
  • Intermediate skills in applicable computer programs
  • Experience of method development in pharmaceutical laboratory or similar field
  • Excellent oral and written communication skills demonstrated through presentations/seminars, project oversight, new service implementation
  • Experience with Liquid Chromatography (SEC, RP, IEX)
  • Experience with Mass Spectrometry (Intact Molecular weight, Peptide mapping, Disulfide mapping, Glycan Profiling, N-/C-Terminal Sequencing)
  • Experience with Capillary Electrophoresis Methods (CE-SDS, cIEF)
  • Experience with qPCR
  • Experience with Compendial assays

Tasks

  • Serve as subject matter expert in method development, validation, and testing transfer
  • Understand and apply GMP requirements for validation, transfer, and documentation
  • Guide Associate Scientists and study managers in analytical methods
  • Apply laboratory techniques to solve specific problems
  • Lead method development, validation, and feasibility/transfer studies
  • Prepare and review protocols, reports, SOPs, and technical specifications
  • Execute methods for assay development, validation, feasibility, and transfer
  • Perform testing according to SOPs and cGMP regulations
  • Transfer GMP assays to routine team and train relevant personnel
  • Operate and maintain lab equipment as per SOPs
  • Use computer programs for testing and routine tasks (Word, Excel, Oracle, LIMS, BRIQS)
  • Lead change control and resolve deviations by completing event records
  • Contribute ideas to improve lab techniques, protocols, processes, and equipment
  • Ensure regulatory requirements and client needs are met
  • Maintain strong communication skills for internal and external interactions
  • Engage directly with clients
  • Perform other assigned duties

Work Experience

  • 10 years

Education

  • Bachelor's degree

Languages

  • EnglishBusiness Fluent

Tools & Technologies

  • Liquid Chromatography
  • Mass Spectrometry
  • Capillary Electrophoresis Methods
  • qPCR
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