Production Scientist for Molecular Diagnostics

2 days ago


Cambridge, Cambridgeshire, United Kingdom Biofidelity Ltd Full time

About Biofidelity Ltd:

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Biofidelity Ltd is a leading genomic technology company that utilises innovative technologies to drive the transformation of human health and the world we live in. Our focus on adaptability and precision allows us to unlock the full potential of genomics, enhancing decision-making processes and accelerating breakthroughs.

At Biofidelity, we value a culture of humanity, openness, and high expectations, fostering an environment where talented individuals feel empowered to contribute their expertise and collaborate effectively. We strive to maintain a strong sense of community, driving progress through open communication, continuous learning, and mutual respect.

Biofidelity's core values serve as the foundation of our company culture, embracing Humanity- empathy, care, and understanding; Openness- transparency, experimentation, and innovation; and High Expectations- fearlessness, ambition, and resilience. As a collective, we aim to create a collaborative and inclusive workplace that supports growth and encourages individuals to pursue their passions.

Job Summary:

This exciting opportunity requires a highly motivated and skilled molecular diagnostic Production Scientist to lead the production of molecular diagnostic assays. Reporting directly to the Production Manager, you will spearhead the design transfer, process improvement, and production of these assays, upholding the highest standards of quality, consistency, and regulatory compliance.

Duties and Responsibilities:

• Design and execute the production of molecular diagnostic assays, incorporating reagent formulation, assay assembly, and quality control testing

• Develop and implement process improvements, focusing on efficiency, cost reduction, and enhanced product quality

• Conduct thorough quality control assessments, ensuring compliance with established specifications

• Maintain accurate and detailed production records, adhering to quality and regulatory guidelines

• Troubleshoot production-related issues, collaborating with cross-functional teams to find effective solutions

• Collaborate with internal stakeholders to develop and refine process controls and validate product specifications

Requirements:

• Bachelor's degree in molecular biology, biochemistry, biotechnology, or a related field (Advanced degree preferred)

• Minimum 3 years of experience in IVD molecular diagnostic assay production regulated environment

• Strong analytical and problem-solving skills, with the ability to manage multiple priorities and deadlines

• Excellent communication and collaboration skills, with experience working in cross-functional teams

• Familiarity with laboratory equipment operation, validation, and maintenance, as well as ISO 13485 and associated regulations

• Ability to learn quickly and adapt to changing environments, with a strong commitment to quality and regulatory compliance

The estimated salary for this role is approximately $105,000 annually, reflecting industry standards and the required qualifications and experience. Additionally, the benefits package offered by Biofidelity Ltd includes comprehensive medical, dental, and life insurance, pension, income protection, and other incentives designed to support employee well-being and professional growth.



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