Senior Molecular Scientist: qPCR & ISO13485 (Belgium)

Signatur Biosciences Ltd; Luik; Sur place; EUR 55 000 - 85 000; Plein temps

Avantages offerts par ce poste

Private medical insurance

Paid time off

Résumé du poste

Signatur Biosciences seeks a highly motivated Senior Technical Assistant to establish our new Belgium lab in Liège, on-site. You will develop, implement and maintain ISO13485 compliant procedures, generate data to support next-gen molecular diagnostics, and collaborate with cross-functional teams to drive accessible precision diagnostics.

Requirements include a PhD or MSc in biology-related fields, 3+ years molecular biology lab experience, ISO13485 knowledge, and familiarity with

Qualifications

• PhD, Master or equivalent Science degree in biology, molecular biology, synthetic biology, bioengineering, or similar, with equivalent experience.
• At least 3 years of hands-on molecular biology laboratory experience (not including course work)
• Experience working within a Quality Management System for In Vitro Diagnostic development (ISO13485)
• Familiarity with a scientific programming language (Python, R, Matlab or Julia)
• Previous start-up industry experience
• Experience in using automated PCR set-up
• Experience of working within biobanking requirements
• Experience in writing study protocols following relevant international guidelines (i.e. CLSI)
• Mentoring and/or coaching team members

Responsabilités

• Adhere to laboratory procedures to ensure a safe and effective laboratory environment
• Assist in sourcing, storage, handling and maintenance of records with regards biological samples in accordance with the relevant requirements
• Be responsible for the work instructions and training for specific laboratory processes/equipment as a lab process expert
• Contribute to the laboratory processes / procedures implementation in accordance with In Vitro Diagnostic development (ISO13485)
• Support the Head of Laboratory Operations in the implementation and monitoring of metrics (Key Performance Indicators) of laboratory efficiency & effectiveness
• Contribute towards the continuous improvement and operations of Signatur Biosciences
• Training and coaching of laboratory team members
• Take ownership of writing study protocols to achieve project objectives
• Ensure the efficient translation of study plans and protocols into detailed laboratory work instructions/worksheets to enable laboratory execution
• Support with generation and review of design and development documents
• Work with external partners and providers to advance project objectives
• Work across the R&D team to anticipate reagents and consumable needs
• Take ownership of data analysis and report writing
• Train the laboratory team on the study protocols/work instructions
• Conduct laboratory studies in accordance with work instructions and/or study protocols in support of research and/or product development projects including:
• Performing qPCR experiments manually or using high-throughput liquid handlers (for example i.DOT machine)
• Carry out nucleic acid extractions according to specified protocols or work instructions
• Execute laboratory studies with a 1st time right mentality, leading by example
• Document experiments according to the Quality management System requirements ensuring timely, neat, complete and accurate records
• Recognized as Subject Matter Expert in diagnostic research, development and/or manufacturing
• Contribute to, and where necessary take the lead in trouble shooting and investigations of unexpected results
• Work proactively to ensure barriers to project execution are removed

Connaissances

PCR expertise

Nucleic acid extraction

Study protocol writing

Laboratory record keeping

Lab coordination

Mentoring/coaching

Startup experience

Automated PCR setup

Biobanking requirements

CLSI guidelines familiarity

Formation

PhD or MSc in biology or related

Outils

Python

R

Matlab

Julia

Description du poste

Signatur Biosciences seeks a highly motivated Senior Technical Assistant to establish our new Belgium lab in Liège, on-site. You will develop, implement and maintain ISO13485 compliant procedures, generate data to support next-gen molecular diagnostics, and collaborate with cross-functional teams to drive accessible precision diagnostics.

Requirements include a PhD or MSc in biology-related fields, 3+ years molecular biology lab experience, ISO13485 knowledge, and familiarity with