Genomics & Diagnostic Solutions
We are expanding our capabilities in our Genomics Consumables business and looking to engage the appropriate expertise to lead technical contributions in this product area, with a particular focus on Next Generation Sequencing and Molecular Diagnostic workflows.
Experience relating to genomic/molecular biology technologies and applications e.g., nucleic acid extraction, isolation, purification and analysis, nucleic acid modifying/amplification enzymes, as well as development of magnetic particles in applications and products is desired. Familiarity with the use of automated liquid handling systems for these applications and NGS bioinformatics/data analysis would be an advantage.
This role presents a unique opportunity to join our dedicated, motivated, and innovative team. Located at the Cardiff, UK site and reporting to the local site R+D Leader.
You will be involved in the transition of projects from research to development, manufacture and product launch, as well as post launch activities such as customer issues and support, being capable of lone working but also able to work within and influencing cross-functional teams.
Responsibilities will include:
- Execution of cross-functional tasks, including concept discussion, program execution, product design, specification, characterisation and analysis for use in customer assay applications.
- Design and completion of appropriate test and characterization procedures, pilot trials, and commercial field delivery.
- Motivate the team and drive a sense of urgency on meeting program commitments.
- Work with cross functional teams defining and prioritizing the program objectives, critical success factors and deliverables for the team, develop process validation and design transfer protocols, project plans and ensure adherence to schedules and project deadlines. Including to drive manufacturing transfer, efficiency, and reliability.
- Address regulatory issues to enable products that are developed, manufactured, or distributed to meet required standards.
- Good working knowledge of CAPA systems, resolving and assisting in the closure of deviations initiated during qualification/validation execution. Initiate and implement change control activities in accordance with site procedures.
- Working with the team to deliver quality outcomes on time and within budget.
We are looking for candidates with ~ 5 years productive and broad assay experience, and preferably with PhD or equivalent. Experience of working within a large-scale industrial environment, diagnostic, CRO or clinical analytical assay setting with working knowledge of Medical Device 13485 or other Quality Systems Management/Medical device experience would be beneficial.
- Sound technical and domain experience.
- Demonstrated experience on global product releases throughout the entire NPI cycle.
- Strong written and oral communication skills.
- Self-starter, energizing, results oriented, and able to multi-task.
- Demonstrated problem solving ability and results orientation.
- Demonstrated LEAN skills.