Production Technician

Cambridge, United Kingdom
Operations /
Permanent, full-time /
On-site
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.

The role
Biofidelity is building its Production team responsible for the development, implementation, and continuous improvement of business and manufacturing processes and methods to ISO 13485.  As a Production Technician, you will be an essential member of our production team, responsible for the manufacturing and quality control of molecular diagnostic assays and reagents. You will play a crucial role in ensuring the production process meets strict quality standards, regulatory requirements, and production schedules. This role reports to the Production Manager.
 
Key responsibilities:
       Production:
-Execute production protocols to manufacture molecular diagnostic assays and reagents, following established procedures and batch records.
       Quality Control:
-Perform quality control checks and tests on raw materials, intermediates, and finished products to ensure adherence to product specifications and regulatory standards.
       Documentation:
-Maintain accurate and detailed records of all production activities, including batch records, deviations, and any required documentation.
       Equipment Maintenance:
-Operate, maintain, and troubleshoot production equipment and instruments to ensure optimal performance and minimise downtime.
       Inventory Management:
-Manage inventory levels by monitoring stock levels, ordering materials, and participating in inventory audits.
       Adherence to SOPs:
-Follow standard operating procedures (SOPs) and safety guidelines to ensure a safe and compliant working environment.
       Team Collaboration:
-Collaborate with cross-functional teams, including research and development, quality control, and regulatory affairs, to support product development and continuous improvement efforts.
-Support Operations and product development teams as required in order to deliver product and development projects.
       Compliance:
-Ensure compliance with quality and regulatory requirements, throughout the production process.
 
Knowledge, Skills and Abilities:
      Proficiency in molecular biology techniques, aseptic techniques, and laboratory equipment operation is a plus
      Experience of working within an ISO13485 environment is advantageous
      Adaptability: Willingness to learn new techniques and adapt to changing production requirements
      Strong teamwork ethic and the commitment to successfully deliver to tight deadlines
      High accuracy and attention to the detail is a must for both laboratory and office-based work
      Clear communicator, with a ‘can do’ attitude
 
Requisite Education and Experience / Minimum Qualifications:
      A Bachelor's or advanced degree in molecular biology, biochemistry, genetics, biotechnology or a similar subject is required
      Minimum of one-year prior industry experience in molecular biology or diagnostic production (essential)