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Salary Biofidelity is a revolutionary genomic technology company dedicated to unleashing the potential of genomics to transform human health and the world we live in. Our adaptive platform technology removes the noise from genomic data, providing only the information needed to make decision making less complex, faster, and more accurate.
At Biofidelity we are proud to have built a culture of humanity, openness and high expectations. We work towards well-defined goals, with a strong belief that we can make genomics globally accessible. Our people are keen to take responsibility for their work and share both their successes and challenges.
Alongside a competitive salary and opportunities for career development, we offer a comprehensive benefits package including private medical & dental care, bonus, share option scheme, pension, income protection and life insurance, cycle to work scheme, season ticket loan, 26 days per year holiday allowance and free physical training sessions.
The role
We are seeking a highly motivated and skilled molecular diagnostic Production Scientist to join our dynamic team. The ideal candidate will play a key role in the design transfer, process improvement, and production of molecular diagnostic assays, ensuring the highest standards of quality, consistency, and regulatory compliance are maintained throughout the manufacturing process. This role will report to Production Manager.
Key responsibilities:
- Assay Production and Transfer:
Perform the production of molecular diagnostic assays, including reagent formulation, assay assembly, and quality control testing. Lead product technology transfers from product development to production including equipment, test method, and process validation plans. Lead product technology transfers to external contract manufacturers.
- Process Optimization:
Continuously identify and implement process improvements to enhance efficiency, reduce costs, and elevate product quality. Including further hardening of assay specifications, and development of additional quality control processes. Scope also includes business process improvements.
- Quality Control:
Conduct thorough quality control assessments, including analytical and functional testing, to ensure assay performance meets established specifications.
- Documentation:
Maintain accurate and detailed production records, batch records, and documentation in accordance with quality and regulatory guidelines.
- Troubleshooting:
Investigate and resolve production-related issues, deviations, non-conformances, complaint escalations, audit issues, and corrective actions in a timely manner.
- Regulatory Compliance: Ensure that all production processes adhere to relevant regulatory and quality requirements (e.g. ISO 13485:2016) and assist in regulatory submissions when necessary.
- Collaboration:
Work closely with cross-functional teams, including Product Development, QC, and QA/RA, to support new product development and validation activities.
- Training:
Provide training, product knowledge transfer, and guidance to production staff to ensure consistent and compliant manufacturing processes.
- Safety:
Adhere to all safety protocols and promote a culture of safety within the production team.
Knowledge, Skills, and Abilities:
- Demonstrated experience working cross-functionally and collaboratively across different teams (including Technology development, Product development, Quality, etc.)
- Proficiency in a variety of molecular biology techniques
- Ability to follow written procedures with minimal direction
- Ability to manage multiple tasks to deadlines, think on feet to solve problems and maintain a high level of accuracy, even in a changeable work environment
- Excellent problem-solving and troubleshooting skills
- Detail-oriented with strong organizational and documentation skills
- Effective communication, interpersonal and teamwork abilities
- Proficiency in laboratory equipment operation, validation, and maintenance
- Familiarity with ISO 13485 and associated regulations for IVD products, for example EU IVDR and FDA
- Experience with automated liquid handling systems is a preferred
- Working knowledge of Six Sigma and Lean Manufacturing principles preferred
- Mathematics and statistics aptitude required
- Data analysis and technical writing aptitude required
Requisite Education and Experience / Minimum Qualifications:
- Bachelor’s degree in molecular biology, Biochemistry, Biotechnology, or a related field (Advanced degree preferred)
- Minimum 3 years of sustaining engineering, process improvement, or design transfer experience in IVD molecular diagnostic assay production regulated environment
