Method Development Analyst - 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 Method Development Analyst. 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 an attractive 80 acre of parkland 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. Method Development Analyst Responsible for the efficient development and establishment of study methods within BioCMC, (may take the role of QC Scientist on non-regulatory work), including day-to-day monitoring and supervision of analyst's work and ensuring procedures are scientifically sound and that they meet client requirements. Has responsibility for the scientific, technical and regulatory conduct of studies allocated to him/her as well as for the approval of study data, interpretation, documentation and reporting of results. The individual has a responsibility to work with QC Scientists and Lead Scientist where appropriate to conduct all work in compliance with applicable regulatory requirements, and specifically those regulations (GLP, GCP and/or GMP) specified in the study plans, protocols, or work agreements governing the work in which they are involved, being the main point of contact for analysts and clients and taking responsibility for ensuring client deadlines are met. They are also responsible for the efficient completion of draft analytical procedures within BioCMC. Take responsibility for technical and practical aspects of designated projects including troubleshooting and method development, especially those that fall at the limits of routine capabilities due to the project complexity of chosen technique. Provide effective communication with all internal staff, including QA and particularly as direct contact for Clients. As required, you will be expected to provide appropriate technical and procedural training for staff to develop their skills and the overall group knowledge base. Should take responsibility for technical aspects of projects undertaken within the group, maintain a track of team activity and strive to keep projects on schedule. Reports to the Assay Development Manager on a daily basis. Education/Qualifications Typically have a relevant scientific degree and/or an appropriate amount of laboratory Experience . A PhD would also be of advantage for this position in a relevant field. Experience - To be successful in this role we are looking for previous Experience in method development - Computing skills, including word processing and use of spreadsheets (e.g. Word, Excel). - In-depth understanding of Health and Safety policies, Company Policies and Procedures, a working knowledge of ISO (accreditation and application), and an in-depth understanding of the GxPs. - Excellent project management and communication skills. EEO Employer . Keywords: Method Development Analyst, CMC, Chemistry Manufacturing Control, Biopharm, Biopharmaceutical CMC Solutions, Early Development, Large Molecule, GMP, Gxp, GCP, GLP, HPLC, Mass Spectrometry, ELISA, Cell Based Assays, PCR, Molecular Biology, Cell Culture, UK, Yorkshire.