Metabolomic Diagnostics are currently seeking an Assay Development Project Manager to join our team. The Assay Development Project Manager is responsible for leading and managing projects to develop assays using LCMS and Immunoassay platforms for Research Use Only (RUO) and In Vitro Diagnostic (IVD) use.
- Leading a multidisciplinary project team to develop assays from concept through to commercialization, with full accountability for project delivery. Technical Lead reporting to senior management.
- Ensuring that projects have clear goals and milestones that are aligned with those of the business, and supporting project team members to set and achieve their own goals and outputs accordingly.
- Creating assay development project plans through all stages of development, supported by key technical, operational, quality and regulatory staff.
- Full responsibility for managing project budgets, schedules, resources and risks.
- Regularly updating senior management on project plans, resource requirements, status, risks and mitigations.
- 5+ years of relevant experience managing product development of IVD assays/devices through all stages from concept through to market readiness.
- Experience implementing industry-leading project management best-practices, tools and techniques.
- Degree in Chemical or Physical sciences (or related field) or can demonstrate hands-on experience in these fields.
- A good understanding of the quality-assurance and regulatory frameworks applicable to IVD assays, including FDA and CE-IVD requirements.
- The ability to lead and manage technically complex projects with multi-disciplinary project teams.
- Excellent time-management, planning, and organization are required to be successful in this role.
- Excellent communication and leadership skills.
- Ability to work successfully in a fast-paced, deadline-driven environment.
- An understanding of markets, customers and competitive landscapes for research-use and diagnostic assays is desirable.
- Experience of developing and launching mass-spectrometry-based assays is desirable.
- An understanding of working in an innovative early-stage environment is beneficial.
Working with Metabolomic Diagnostics:
Metabolomic Diagnostics Ltd is an early stage biotechnology company located in Cork, Ireland. The company is developing novel and innovative tests to predict pregnancy-related complications by the detection and quantification of biomarkers present in the blood. Having been ranked among the top innovators in Europe, Metabolomic Diagnostics was recently awarded €2 million in EU Funding under the Horizon 2020 SME Instrument.
The position presents a unique opportunity to be part of a dynamic, international team focussed on delivering novel products to the market. The Assay Development Project Manager will be instrumental in building Metabolomic Diagnostic’s product portfolio.
Metabolomic Diagnostics offer a competitive salary package and opportunities for career development.
Contact: Interested applicants should contact: firstname.lastname@example.org