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.
Biofidelity’s core values are Humanity- care & compassion; respecting personal lives; humour. Openness- sharing research; experimental approach; permission to fail. High expectations- be fearless; make a difference; willingness to do what’s needed. Our core values define our company culture, they are shared values, goals, attitudes and practices that characterise Biofidelity employees. We are looking for likeminded people to join the Biofidelity team.
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.
Biofidelity is seeking a Senior Production Scientist to join our team. In this role, you will be responsible for 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 reports to the 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. Preparation of DNA and RNA contrived materials.
· 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. Support with QC method development and establishing performance specifications
· Documentation:
Maintain accurate and detailed production records, batch records, and documentation in accordance with quality and regulatory guidelines.
· Troubleshooting:
Take the lead in supporting and resolving investigations into production-related issues (deviations, non-conformances, complaint escalations, audit issues, and corrective actions) and ensure completion within a timely manner based upon risk.
· 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 and external suppliers, to support product development and validation activities (including technology transfers).
· Supervision and Training:
Support the Production Manager with supervision and training of the Production team through product knowledge and expertise in order to ensure consistent and compliant manufacturing processes.
· Safety:
Support Production Manager with the implementation of Health and Safety processes, compilation of all safety documentation. 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, external stakeholders, etc.)
● Proficiency in a variety of molecular biology techniques- skills and experience in the following are essential: multiplexed PCR/qPCR, DNA/RNA extraction and sample preparation.
● Experienced in supervising junior team members.
● 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
● 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 (PhD preferred)
● Minimum 5 years of experience within a molecular diagnostic assay production regulated environment or similar.
