Source BioScience Limited is an international provider of integrated state of the art Laboratory Services and Products. Headquartered in the UK, with offices in UK, Europe and the USA, Source BioScience is a fully owned subsidiary of SourceBio International plc.

Day to day site management of the US Source Bioscience facility composed of the Stability Storage suite and the Sanger Sequencing Laboratory. To generate increasing sales for a new laboratory testing facility to be built in San Diego.

The overall objective is to deliver services from the portfolio to customers of Source BioScience to ensure that the activities are performed within the quality performance indicators and according to the relevant Standard Operating Procedures and that the integrity of customer supplied products and samples are maintained at all times.

The post-holder will be expected to work to quality standards, financial regulations operational deadlines and lead new quality initiatives.

Key responsibilities and duties include but are not limited to:

• Leading and managing the Stability Storage and Lifescience team to ensure efficient and effective operation of the suite at all times.
• Senior responsible person for the site facilities, including ensuring that all local licences are adhered to and the point of contact for Source BioScience and client enquires in the US.
• Liaising with clients and UK staff to ensure clients receive complete and accurate information concerning practical operation of the suite and laboratory.
• Ensuring FDA, ICH and GMP regulations are applied and adhered to at all times throughout the suite.
• Hosting Client audits.
• Provide complete, accurate and timely management information including reporting capacity levels and issues in a timely and accurate fashion to relevant stakeholders.
• Working with the Finance team to ensure all work is accurately invoiced.
• Working with the Laboratory Operations lead initiatives within the site that will ensure the most efficient and effective management of the Operational areas.
• Co-ordinating with relevant staff to ensure effective validation and servicing of suite equipment as necessary.
• Reporting of all out of Specification incidents, deviations and Customer Complaints to the Quality Assurance Officer in accordance with SOPs.
• Ensuring peripheral equipment (e.g. data loggers, elgas, etc) is operational at all times, reporting of equipment breakdowns in a timely fashion. Maintaining critical spares in accordance with suite requirements.
• To generate increased sales in the laboratory services provided out of San Diego.
• Performing the duties of the storage technician or sequencing scientist as required, to ensure the smooth running of the suite.

Job Description

Able to work supportively as part of a team and with a friendly and approachable personality.

Support the Quality team and Auditors in maintaining:

• ISO 9001 Quality System requirements, EU (Directive 2003/94/EC) and USA (eFR 21 Part 210/211) current Good Manufacturing Practice regulations and HTA regulations .
• 21 CFR Part 11 regulations - FDA guidelines for electronic records and electronic signatures
• ICH Topic Q1A (R2) - Stability Testing of New Drug Substances and Products
• ICH Topic Q1B (R2) - Photostability Testing of New Active Substances and Medicinal Products
• • Preparation and completion of all relevant documentation and  data  acquisition systems.
• • To comply with all quality control procedures to support maintenance of the Source BioScience's Quality Management System.
  • To comply with safe working practices in accordance with Company safety policies.
  • To participate in the Annual Joint Staff Review process, in accordance with Company Policy.
  • To perform any other duties as may be reasonably required commensurate with grade and experience.
  • Attend any training endeavours as appropriate to role or as reasonably requested.

Due to the volume of applications, we apologise that we are unable to respond individually to each application. If we have not contacted you within 7 working days your application has been unsuccessful and your details have not been retained. Please feel free to apply for any other position you may see in the future.