SUSONITY
NBE DMPK Lead(m/w/x)
Vollzeitnur vor OrtSenior
Darmstadt
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Leading scientific troubleshooting discussions for molecular biology assays in a BSL-2 lab. Master's degree and 8+ years of lab experience required. Focus on LIMS and ELN data entry.
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Anforderungen
- Master’s degree in Biological Sciences or relevant scientific subject
- Minimum 8 years in scientific laboratory role, ideally GMP contract testing laboratory
- Scientific expertise in molecular biology
- Experience in Biosafety Level 2 laboratory
- Computer literacy and data entry (LIMS, ELN, SAP, Oracle)
- Neat and accurate documentation (handwritten and electronic)
- Strategy and business knowledge
- Customer centricity
- Strategic thinking and acting
- Effective troubleshooting skills
- Business understanding
- Operating skills
- Adherence to health and safety procedures
- Orchestration of multiple parallel activities
- Workload planning and task assignment
- Effective communication for job-related information
- Experience with technical disciplines
- Liquid Chromatography (SEC, RP, IEX)
- Mass Spectrometry (Intact MW, Peptide mapping, Disulfide mapping, Glycan Profiling, N-/C-Terminal Sequencing)
- Capillary Electrophoresis Methods (CE-SDS, cIEF)
- qPCR
- Compendial assays
- Energy, drive, and need to finish
- Achieves goals, pushes self and others for results
- Effective under pressure, optimistic and persistent
- Builds constructive relationships with diplomacy and tact
- Team player, cooperative, encourages collaboration
- Effective communication skills
- Effective conflict handling
Aufgaben
- Review proposals for projects
- Act as responsible scientist on complex technical projects
- Respond to routine assay inquiries
- Review and monitor assay performance
- Lead scientific troubleshooting discussions during investigations
- Maintain in-depth understanding of Contract Testing Services and BioReliance® services
- Maintain in-depth understanding of technical principles and advances in the field
- Maintain effective working relationships with development services, commercial, SMEs, and laboratory personnel
- Lead new assay and technology transfer
- Act as Responsible Scientist for routine and complex assays
- Hold responsibility for the overall conduct of GMP studies
- Plan, organize, and prioritize workload to ensure timely and effective testing
- Ensure timely issuance of studies Certificate of Analysis (COA)
- Ensure routine and complex client studies are completed on time to appropriate scientific and regulatory standards
- Work with Lab Manager/Manager on testing schedule for laboratory personnel
- Provide hands-on support, training, guidance, and mentorship to laboratory personnel
- Act as subject matter expert and offer scientific coaching and mentoring
- Author, review, and approve study and other technical scientific documents
- Design, direct, and lead complex projects
- Ensure trending spreadsheets are completed in a timely manner for all studies
- Author and review assay risk assessments
- Ensure all assays/processes are in a validated state in line with current regulations
- Maintain scientific integrity of routine and non-standard assays methods
- Advise on and implement assay improvements
- Lead process improvements within the laboratory to improve quality and performance
- Perform regular housekeeping laboratory checks and Health and Safety audits
- Host internal Quality Audits representing the laboratory
- Participate in client or regulatory audits
- Respond to audit observations through the BioReliance Quality System
- Lead and ensure deviation and Corrective or Preventative Action (CAPA) records are completed in a timely manner
- Raise and progress Change Control for new service, testing, and assay validation introduction
- Act as scientific consultant to support departmental investigations, client product queries, supplier audits, and client/regulatory inspections
- Liaise with Commercial, Development Services, Programme Management, and other Laboratory Operations to provide technical support
- Act as point of contact for routine study inquiries
- Write Genetically Modified Organism (GMO) risk assessments
- Ensure a safe and healthy work environment by complying with and embracing health and safety policies and procedures
Berufserfahrung
8 Jahre
Ausbildung
Master-Abschluss
Sprachen
Englisch – verhandlungssicher
Tools & Technologien
LIMSELNSAPOracleLiquid ChromatographyMass SpectrometryCapillary Electrophoresis MethodsqPCR
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