BIOFIDELITY is looking for employees for positions:
production manager
Working hours
full-time | Permanent
Responsibility
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
develop and maintain production schedules to ensure timely delivery of products
monitor production progress and adjust schedules as needed to meet demand
the role
biofidelity is a revolutionary genomic technology company dedicated to unleashing the potential of genomics to transform human health and the world we live in
biofidelity is creating a dedicated Manufacturing team responsible for the supply and scaling of its product portfolio
Education
bachelor's degree in a relevant scientific or engineering field; advanced degree preferred
strong knowledge of molecular biology techniques and diagnostic assays
previous experience of working under ISO 13485
minimum of 5 years of experience in molecular diagnostics or biotechnology production, with at least 2 years in a supervisory or management role
Requirements
demonstrated experience working cross-functionally and collaboratively across different teams
proficiency in a variety of molecular biology techniques and principles
knowledge in clean formulation and molecular grade processing required
knowledge in production automation systems preferred
applied knowledge of Six Sigma and Lean Manufacturing principles preferred
mathematics and statistics aptitude preferred
proficiency in Product Life Cycle Management and change control preferred
working knowledge of cost accounting/manufacturing finance preferred
quality manager
Working hours
full-time | Permanent
Responsibility
developing and delivering Quality training across the company
planning, initiating, and managing quality continuous improvement projects
supporting investigations and complaint handling
ensuring supplier and subcontractor compliance to Biofidelity requirements
acting as a point of contact with certification authorities, including arranging and planning for assessments
creation and Maintenance of product medical device files. Assisting with drafting and compilation of product documentation for regulatory submissions
delivering and maintaining an ISO 13485:2016 Quality Management System, initially for Design and Development
supporting the product and software development teams with design control and risk management in accordance with ISO 14971:2019, through prior experience, training, and education
Education
degree in science, medical or technical field
lead Auditor Qualified
proven Quality Managerial experience in ISO 13845:2016, with at least 3 years as the Quality lead i.e. Management Representative
Requirements
previous experience in implementation and management of an ISO 13485 QMS
knowledge and demonstrated experience within design and development of molecular diagnostic reagents, consumables and IVDs
excellent organisational, communication and leadership skills
results-oriented, with strong attention to detail
practical knowledge of other applicable standards and regulations including IEC 62304, ISO 14971, 21 CFR 820, 21 CFR Part 11, IVDR 2017/746 EU
laboratory technician
Working hours
full-time | Permanent
Responsibility
performing routine laboratory functions to support scientific experiments and investigations
helping Lab Manager with stock and waste management
manufacturing reagents based on written work instructions according to Quality standards, which will be assembled in the kit
preparing reagents based on written work instructions according to Quality standards
quality control of raw material and reagents using provided QC method
writing Quality documentation
processing whole blood samples from healthy donors and patient samples
Education
A Bachelor's or advanced degree in molecular biology, biochemistry, genetics, biotechnology or a similar subject is required
at least one-year industrial laboratory experience preparing reagents or running molecular biology assays
A Bachelor's or advanced degree in molecular biology, biochemistry, genetics, biotechnology or a similar subject is required, with a minimum of one-year laboratory experience
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
experience in manufacturing reagents and quality control
experience in PCR and qPCR analysis is advantageous
experience in PCR and qPCR analysis
experience with QMS is advantageous
experience of working within an ISO13485 environment is advantageous
office manager
Working hours
full-time | Permanent
Responsibility
provide general administration support - manage company records, ensuring they are kept up to date and filed
support Senior Leadership Team with diary assistance and meeting bookings
organise and coordinate other company meetings
arrange conferences, travel, and hotel bookings for the team
process purchases, invoices and expenses using Xero Accounting
support recruitment, contact applicants and make interview arrangements
work closely with the People team to organise and manage onboarding and induction for new employees
provide support with HR administration and HRIS
Education
proven previous experience in a similar role, with diverse and hands on responsibilities in a fast-paced environment
proven previous experience providing support to the C-Suite level
experience with contract management
experience in inputting accounts invoices or data entry using Xero Accounting or similar accounting software
experience with HR administration
previous experience in life sciences or healthcare industry
Requirements
excellent attention to detail and ability to produce high-quality work
impeccable organisational skills coupled with methodical and structured approach
ability to think on feet to solve problems and maintain a high level of accuracy, even in a changeable work environment
proficiency in GSuite and Microsoft products
strong numerical and administrative skills
strong written skills demonstrated in a range of contexts
excellent communication & interpersonal skills and ability to relate to people at all levels demonstrating highest level of professionalism
ability to multi-task whilst prioritising workload and ability to work independently
data scientist
Trade
Mathematics
senior software engineer
Trade
software Development
Software Development
Responsibility
design and architecture of projects to fulfil key software requirements
implement components of a project writing clean, testable code
perform code reviews and provide technical guidance to more junior team members
write and maintain tests and documentation
help to develop and maintain infrastructure code and deployment pipelines to support operations and releases
work with the quality team to ensure compliance with relevant regulations, and contribute to continual improvement of quality processes
Education
full stack software development experience in industry
experience developing applications as part of a cloud based solution
experience in CI, deployment automation and monitoring for cloud based solutions
experience with security, authentication and access management
familiarity with relational databases , schema design and ORMs
experience with orchestration, provisioning and containerisation such as Kubernetes, Nomad, and Docker
experience in requirements gathering and development of use cases, technical specifications and design documentation
prior experience adhering to Software Development Life Cycle processes and/or working within a quality management system to ISO 13485, IEC 62304, or ISO 27001
Requirements
clear communicator, with the ability to work across the company including non technical colleagues
willingness to learn new technologies and skills as required and happy to take ownership of projects in a small team environment
research scientist
Trade
scientific Research & Development
Scientific Research & Development
Education
phD in molecular biology or MSc and 3-5 years relevant academic or industrial experience
Requirements
proficiency in molecular biology techniques such as PCR , qPCR , isothermal amplification and nucleic acid extraction
demonstrated ability to apply knowledge and expertise to complex challenges
broad understanding of assay development methodology including testing of sensitivity and specificity
skilled in pushing molecular techniques into new areas, potentially working at single molecule levels
ability to design, execute and analyze experiments with minimal support from Senior Scientists
ability to read and understand scientific content and apply to ongoing work
familiarity with laboratory equipment and instrumentation used in molecular biology assays, including pipettes, centrifuges, thermal cyclers, and spectrophotometers
understanding of laboratory safety protocols and procedures to ensure compliance with regulations and maintain a safe working environment
Responsibility
collaborate with interdisciplinary teams including biologists, bioinformaticians, engineers, and clinicians to ensure the assay meets the requirements of the intended application
production technician
Education
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
Requirements
proficiency in molecular biology techniques, aseptic techniques, and laboratory equipment operation is a plus
experience of working within an ISO13485 environment is advantageous
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
adaptability: Willingness to learn new techniques and adapt to changing production requirements
Responsibility
follow standard operating procedures and safety guidelines to ensure a safe and compliant working environment
collaborate with cross-functional teams, including research and development, quality control, and regulatory affairs, to support product development and continuous improvement efforts
perform quality control checks and tests on raw materials, intermediates, and finished products to ensure adherence to product specifications and regulatory standards