In CircaGene, we believe that this vacancy opens vast opportunities for the candidate, allowing him to develop the regulatory skills, which will significantly raise the value of the professional profile in a post-pandemic market, where there is a constantly growing number of companies developing various diagnostic platforms.
Primarily, this job position is highly recommended for Python developers who wish to pursue their career in product development management, especially related to diagnostic and medical systems, a booming industry.
The objective of the successful candidate will be to guarantee compliance of a BioInformatics pipeline and processes to the following standards:
Your skillset includes IT and Organisational skills, Written communication skills, attention to detail and Team working.
• Actively contribute to the documentation of the bioinformatics pipeline component of Internal’s targeted sequencing solution and documentation of procedures and process configurations.
• Guarantee compliance of Bioinformatics processes to Quality standards.
• Train Internal users to Bioinformatics SOPs, from using the BioInformatics pipeline autonomously to data management (From Medical data to Sequence databanks).
• Actively promote interactions within the Bioinformatics team by setting up compliance reviews.
• Participate in relevant regulatory forums to help ensure our product designs reflect the Bioinformatics challenges of regulated diagnostic sample-to-answer sequencing tests.
• Partners with the IT, Regulatory and Software teams to document, test and validate new analytical tools and processes.
• Ensures compliance with all relevant standards to guarantee security and confidentiality of transactions. Actively support IT team to reach highest standards in cybersecurity of BioInformatics data (both in the final diagnostic platform and the Internal’s environment).
• Other duties as assigned.
Ideally, the candidate should have MS or PhD in Computer Science, Physics, Mathematics, equivalently technical discipline, or extensive software product development experience.
• Confident in windows and Linux environments, Git source code repository, jenkins.
• Clear communication skills and proven ability to train others.
• Demonstrated ability to work autonomously and remotely (online work with daily stand-up meetings and frequent online interactions within the BioInformatics and several other internal teams such as IT, regulatory and Software).
All deliverables refer to the Software Unit “Secondary Data Analysis” as defined in SOP-100 (Software Development Procedure):
1. Software DDP (Consistency, compliance, BioInformatics tasks)
2. Updated list of OTSS linked to BioInformatics pipeline.
3. Write and update the documentation about the Assay Decision tree
4. Support Software DDR
5. Provide support on the reporting about End-to-end on A1/A2 and BBs (“DR3”)
6. Support the workaround dFMEA
7. Write and update the Bioinformatics documentation necessary for the Initial Assay Caller Design Lock 8. The documentation linked to the BioInformatics reporting file transmitted to the firmware (Format: JSON BioCompute object)
9. Assessment and documentation of risks linked to the BioInformatics pipeline.
10. Software test (IQOQPQ) reports linked to BioInformatics pipeline 11. Bioinformatics Software Release Letter
12. BioInformatics Software Traceability Matrix