Join our new lab in York, UK!
BioPharmaceutical CMC Solutions – Large Molecules (BioCMC) is expanding and we have opened the doors to our new 17,000ft2 High quality lab near Sand Hutton, York.
We are currently recruiting for a QC Scientist.
The BioCMC solutions Division in York accommodates: Protein Chemistry, ELISA & Cell Based Assay’s. The facilities will also include a Sample management Lab, Stability suite, Mass Spec, Cell storage suite, Waste management inc. autoclave and Consumables store.
The lab is based on attractive 80 acre of parkland setting on the NAFIC Business Park a few miles north of York and comprises of an On-site Gym, nursery, restaurant & café. There will also be designated parking for Covance employees.
Working as part of the QC Laboratory Operations Group, the QC Scientist routinely manages a number of assays pertaining to common techniques. Typically, the QC Scientist will work on single projects (for one or several related techniques), or be part of a larger cross-sectional project working in conjunction with a Lead Scientist (LS). Project requirements may include, but are not limited to; (complex) assay transfer, validation, samples analysis, batch/release testing, and stability studies. They will write protocols and reports, prepare and review analytical procedures, and be accountable for the approval and integrity of data and associated quality documentation. The QC Scientist has knowledge within a relevant field and is able to troubleshoot techniques in the area of their expertise. The management and approval of assay data by the QC Scientist forms a large area of responsibility for GMP projects. They may also be required to act as a Study Director or Principal Investigator for GLP projects, or Responsible Scientist for GCP projects. The QC Scientist is therefore required to adapt to changing regulatory requirements, depending on project types.
In this role, the QC Scientist will provide internal Clients with a central scientific point of contact for techniques within their area of expertise, or for external Clients where the molecule is not overseen by a LS. The individual is accountable for effective communication either directly with the Client or via the LS to ensure that Client requirements and project deliverables are met. This involves discussion with the Client/LS to design proposals/protocols, the Project Management Office (PMO), and communication with QC Section Managers, as well as other scientific and analytical staff. The QC Scientist has scientific oversight of relevant techniques in order to ensure the successful initiation, planning, execution, monitoring and completion of projects.
The QC Scientist is required to have in-depth knowledge of the GMP/GLP/GCP and regulatory guidelines as they ensure that projects are carrried out to the required standards, and that work is conducted in compliance with applicable regulatory requirements.
The QC Scientist will be responsible for overseeing the work of other QC Scientists where appropriate. They will be expected to train, coach and mentor members of the team and across functions as required.
The individual will identify and communicate scientific and regulatory developments within their field of expertise, to include Lead Scientists, QC Scientists and Laboratory Analysts. The QC Scientist will represent Covance internally or externally by preparing and/or giving presentations, writing or supporting the preparation of scientific papers and/or posters, in order to communicate the work of Covance QC laboratory operations.
The QC Scientist will be required to perform lab work as required, and provide support with regards to general laboratory operations and processes, leading by example to members of the QC operations team.
The post holder should typically have: