World-class medical diagnostics
Cambridge Life Sciences is a well-established clinical chemistry company based in Ely near Cambridge. We produce clinical diagnostics tests that are used for medical and research purposes, globally. We are part of a dynamic and fast-moving group. Following its acquisition in 2021, the company is now gearing up for significant expansion and growth into new fields of expertise within medical diagnostics.
We are an equal opportunities employer that provides a friendly, team-orientated working environment focused on providing our customers with the best possible products and highest level of service.
Cambridge Life Sciences Ltd is always interested in hearing from talented people who may wish to join our team. If you believe you have the drive and commitment to be a successful member of our team, please send us your application for the specific opportunities shown below.
To apply please email your CV and covering letter
Agencies: Please note that we use a preferred agency only.
CURRENT VACANCIES
Group QA/QC Manager
We are seeking an experienced Quality Manager who will be responsible for the compliance to IVDR and establishing CE and UKCA marks and the maintenance of our quality management system to meet ISO 13485 & ISO 15189 requirements and Quality Control of the production site.
The role will see you responsible for two sites, harmonising the Quality Management System across both locations and driving continuous improvement within the quality culture.
As Group Quality Manager you will need to be able to juggle managing a team of three whilst also remaining hands on in the day to day quality activities such as:
Key Responsibilities:
- Ensure department targets and objectives are met, including post-marketing vigilance, quality, complaint analysis, product conformances
- Relevant industry background in a quality management position
- Prior experience maintaining a QMS aligned with ISO 13485 and, ideally ISO 15189 (or ISO 9001, ISO 17025)
- Previous experience in attaining CE / UKCA marking
- Preparation experience for external audit by regulatory bodies (BSI, UKAS or similar agency)
- Planning, initiating, and managing quality improvement projects
- Experience in conducting internal and external audits
- Approval of technical transfers and Quality Agreements
- Audit contractors and suppliers etc. to ensure they comply with site standards
- Provide advice and support to sales/ technical personnel and other stakeholders
- Monitor quality data daily, and take appropriate action, make decisions, or highlight when necessary
- Lead all elements of Quality Control, document control, validation, calibrations, customer Quality interface and supplier Quality assurance by developing key supplier partnerships
- Develop and deliver excellence in manufacturing practices and work with team to develop engagement of all employees in the improvement of Quality, creating training and quality standards to enhance and ensure competence
- Management of the Quality Department including annual goal setting, multiskilling, training and management of Quality standards
- Any other duty assigned within the skill of the employee
Essential Criteria:
- Bachelor’s degree in Quality / Science / Engineering or other Technical field
- Manufacturing and distribution experience working in a quality assurance role or related department desired
- People management experience
- Must have an understanding of common problem-solving tools
- Experience in Lean Six Sigma with certification required
- Audit qualification or experience
Desirable:
- Strong leadership and change management skills
- Candidates from a Medical Device background with FDA/ISO or having substantial experience with ISO 9001/13485 will have an advantage
- Exceptional problem solving and analytical skills with the ability to make quick and appropriate decisions. Proficient at multitasking and prioritizing
- Thorough knowledge and understanding of manufacturing systems and solid working knowledge of processes and products
Chief Technical Manager
Overview
Cambridge Life Sciences is a well-established medical diagnostics specialist, based in Ely near Cambridge. We produce clinical diagnostics tests that are used for medical and research purposes, globally. Upon its acquisition in 2021, Cambridge Life Sciences became part a successful and dynamic group which is now investing to drive the growth of our company. We are now gearing up for rapid growth and expansion into new fields of expertise within medical diagnostics.
Cambridge Life Sciences requires a creative and experienced technical lead to foster product innovation. You will be an expert in your field and will use your ideas to enthusiastically expand and strengthen our product offering. You will guide product development of clinical chemistry and molecular diagnostics products, and expand our reach within diagnostic services.
Essential Requirements
- Solid experience of developing clinical products within CE or ISO 13485 is essential. Knowledge of IVDR, IVDD or ISO 15189 will be an advantage.
- Minimum of a good honours degree in biological sciences or a related subject. A PhD or Masters degree is preferred.
- Knowledge of the science associated with the use and manufacture of clinical chemistry or molecular diagnostics products, preferably within immunology, PCR, or a related specialism.
- Have a working understanding of Quality Management Systems particularly ISO 13485:2016.
- The ability to work swiftly with close attention to deadlines.
- A flexible and creative approach to the demands of a small business.
Key Responsibilities
- Ensure all development projects are well-managed, and run to budget and timescale.
- Manage the R&D team including professional development, performance management, team-building
- Manage the departmental budget against various projects and activities
- Manage the product lifecycle, including guiding the development of enhanced and novel products
- Work closely with the UK General Manager, Technical Development Manager and Marketing team to develop and introduce new products and services
- Provide product and application intelligence to guide product marketing
- Work with the Group QA/QC Manager to ensure existing and future products and projects meet the regulatory requirements.
- Work with the Production Manager to ensure new and existing products are produced according to best scientific practice.
- Ensure implementation and adherence to health and safety procedures.
- Investigate product failures and implement CAPAs as identified.
Summer Internship for Life Sciences Undergraduate - Biological supply chain research
We are seeking a numerate undergraduate student studying life sciences/biology/biochemistry for a paid summer placement. The role will entail researching suppliers for specialist biological reagents for our product range of In vitro diagnostic test kits.
The role is available with immediate start up until October 2023 and will be based at our Ely office. Hours - negotiable - full time is 37.5 hours/week.
Essential Requirements:
- Undergraduate studying life sciences or similar subject
- Highly numerate and able to use spreadsheets
- Analytical skills to be able to research supplies and produce actionable information from the data
- Report writing and presentation skills
Management Accountant
We are seeking a management accountant to provide accounting, costing and budgeting support for Cambridge Life Sciences and report to the parent group, in accordance with company policies and procedures.
The work is onsite in the company office and the office hours are Monday to Friday 9.00 am to 5.00 pm but some flexibility may be available
Essential Requirements:
- Proven ability to calculate, manage and plan accounting and financial records.
- Ability to plan and work with initiative.
Desirable:
- Knowledge of Microsoft Office, SAGE accounting systems (or similar) would be an advantage.
- Attention to detail, task oriented and a flexible and willing approach.
Key Responsibilities:
- Create and prepare internal monthly management reports for the General Manager.
- Prepare draft Management Accounts for the business to be reported to the group.
- Quarterly VAT preparation and reconciliation
- Prepare monthly cash forecasts.
- Prepare profit and loss forecasts as necessary and oversee the annual budget process
- Report to the Financial Controller on a weekly basis and going through any queries.
- Prepare the annual audit files to be sent to the external auditors. Support the annual stock-take.
- Manage the annual insurance process
- Manage the Finance Assistant whose role is to maintain the Sales & Purchase ledger.
- Supervise the month end procedures. Posting journals and prepare workings papers to help this process.
- Manage Credit Control, working with the Finance Assistant.
Qualifications:
- Part or post qualified accountant is desirable and AAT Level 4 Advanced Certificate/QBE is the minimum qualification.
Salary:
- Competitive salary based on experience and qualifications.