Vacancies

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Laboratory IT System Owner, GCLP Laboratory Lund

As Laboratory IT System owner at the laboratory in Lund at MinervaX, you will play a central role in the establishment of a GCLP laboratory for clinical samples from MinervaX’s prophylactic vaccine targeting Group B Streptococcus (GBS). You will be responsible for the software and IT used in the laboratory assuring systems are compliant with regulators requirements.

Your main responsibilities include:

  • Collaborating with external partners and colleagues for validation of laboratory software and systems.
  • Creating and updating documentation that meets the regulatory requirements within the GCLP area in close collaboration with the Director of Clinical Bioassays (e.g. CFR 21, part 11 compliance).
  • Full lifecycle system owner for computerized systems including ELN, LIMS, sample management systems, monitoring systems, laboratory equipment software, and similar.
  • Work closely with colleagues in the laboratory to establish good laboratory processes related to software and IT processes.
  • Responsible for general software updates and maintenance in the laboratory systems.
  • Ensure long-term storage of source data and data protection in laboratory systems.
  • Training of colleagues in the laboratory area in data integrity and the ALCOA+ principles.
  • Knowledge within CSV and GAMP is an advantage.

 

Lab Quality Coordinator, GCLP Laboratory, Lund

As Lab Quality Coordinator at the laboratory in Lund at MinervaX, you will play a central role in the establishment of a GCLP laboratory for clinical samples from MinervaX’s prophylactic vaccine targeting Group B Streptococcus (GBS). The GLCP laboratory is established to move into phase III clinical trials. You will be responsible for the writing, coordination, storage, and maintenance of documentation in the whole laboratory area.

You will be responsible for

  • Writing, reviewing, and updating the SOPs relating to GCLP laboratory, general laboratory processes, sample management, and storage.
  • Coordinating and planning updates of laboratory quality documents in close collaboration with laboratory employees
  • Creating documentation that meets the regulatory requirements within the GCLP area in close collaboration with the Director of Clinical Bioanalysis and QA.
  • Dealing with long-term storage of information and data protection (primarily electronic storage)
  • Revising outdated documents and assuring they are compliant with laboratory processes.
  • Be involved in clinical sample management in the lab.
  • Working closely with colleagues in the laboratory to supporting everyone is completing and submitting the necessary documentation.

 

Manager/Senior Specialist, CMC Quality Assurance

The candidate will be responsible for delivering experienced quality assurance support and advice for MinervaX outsourced manufacturing processes and drug product for clinical trials. In daily work He/She will work closely together with the CMC Team on manufacturing quality matters and challenge and approve documents in connection with development, manufacture, stability, and review/dispositioning of clinical batches.

The main purpose in MinervaX QA is to safeguard patient safety and ensure product quality and compliance in the CMC area, and ultimately provide safe drug products for clinical trials and (later) for commercial use.

Your main responsibilities include:

  • Ensuring MinervaX products used in clinical trials are following the information and documentation provided to Health Authorities.
  • Identifying potential quality gaps and contributing to strengthening CMO production facilities’ compliance level and relationship management within.
  • Support the continuous improvement of the Quality System including CMC Vendor Qualification, Vendor Lifecycle Management as e.g. Audits (including internal audits) and other QA oversight actions
  • Lead Auditor to conduct qualification and recurrent CMO audits
  • Responsible for QA oversight of CMC outsourced activities
  • QA oversight of CMC out-sourced activities and participation in method transfer and tech transfer activities
  • Be an ambassador in improving the Company quality culture, and promote quality awareness through training, mentoring, and participation in teams and task forces.