QC Scientist - York, UK
Join our new lab in York BioCMC is expanding and we are soon opening the doors to our new 17,000ft2 High quality lab. We are currently recruiting for a QC Scientist. The BioCMC solutions Division in York will accommodate: 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 Operations Group, the QC Scientist routinely manages a number of studies pertaining to common techniques. These techniques may comprise single studies or be part of a larger study / project working in conjunction with the Scientific Lead. This may include but is not limited to; validation, transfer, batch release and stability studies. They will write protocols and reports for single studies with no assigned Scientific Lead. The QC Scientist has in depth knowledge in a relevant field and is able to troubleshoot techniques in the area of their expertise. The QC Scientist is accountable for the approval and integrity of the data and associated quality documentation. They are also responsible for the preparation and review of analytical procedures. In this role, the QC Scientist will provide internal Clients with a central scientific point of contact for techniques within their area of expertise. The individual is accountable for effective communication either directly with the Client or via the Scientific Lead to ensure that Client requirements and deliverables are met. This involves discussion with the Client to design proposals, working with Project management, communication with the QC Section Managers and oversight of scientific progress of techniques and studies to ensure the successful, initiation, planning, execution, monitoring and completion of projects. The QC Scientist ensures that the studies are carried out to the required standards ensuring that all work is conducted in compliance with applicable regulatory requirements (GxP). The QC Scientist is required to have an expert knowledge of the GxP and regulatory guidelines. They are the main point of contact for internal and external clients where the molecule is not overseen by the Scientific Lead. Where the molecule is overseen by a Scientific Lead the QC Scientist will act as the main technical contact. 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 expertise to the molecule management team and the wider senior scientific group (Analytical Development and QC Scientists). There is an expectation that the senior members of the QC Scientist team will be required to travel to visit clients and attend conferences, and represent Covance by preparing and/or giving presentations and writing scientific papers in their area of expertise. Education/Qualifications - Typically be educated to a minimum of degree level in a life science subject or equivalent. - Be accredited to or working towards Project Management Professional (PMP) status and maintain status through conference attendance, presentations etc. Experience - We are looking for someone with strong project management Experience within a relevant industry. - The ability to get things done by influencing others (both internal and external). - An up to date knowledge of regulatory guidelines is desirable. - An in-depth understanding of health and safety policies, Company policies and procedures, and an in-depth understanding of the GxPs - Knowledge of drug development process. - Commercial awareness, interpersonal and negotiating skills. - Learn and maintain knowledge of process excellence processes, tools and activities. EEO Employer . Key words: CMC, Early Development, GMP, GxP, GCP, GLP, quality control, ELISA, analyst, Laboratory, Scientist, R&D Scientist, Senior Scientist, Quality Control Scientist, Technologist, Analyst, Technician, Research Scientist, Yorkshire.