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Senior Assay Development Scientist(m/w/x)
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
- English – Business Fluent
Tools & Technologies
- Liquid Chromatography
- Mass Spectrometry
- Capillary Electrophoresis Methods
- qPCR
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Senior Assay Development Scientist(m/w/x)
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
- English – Business Fluent
Tools & Technologies
- Liquid Chromatography
- Mass Spectrometry
- Capillary Electrophoresis Methods
- qPCR
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
SUSONITY
Industry
Healthcare
Description
Das Unternehmen entwickelt Medikamente, intelligente Geräte und innovative Technologien in Therapiegebieten wie der Onkologie, Neurologie und Fruchtbarkeit.
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