Currently recruiting for a QC Scientist in our Harrogate site to join our expanding BIOCMC department.
You would join our Protein Chemistry and ELISA team as a QC Scientist.
These two sections combine to focus on providing analytical support in the drug development pathway for the characterisation and stability assessment of large protein molecules, including: vaccines, antibodies, cytokines and growth factors. The accurate characterisation of a drug is necessary to release manufactured batches of the drug, assess stability (shelf life) and evaluate the impact of changes in manufacturing process or in formulation. This is achieved using a variety of analytical techniques such as: SDS-PAGE, Western blotting, Isoelectric focusing, Capillary electrophoresis, HPLC, spectrophotometry, ELISA, amino-acid analysis, peptide mapping, and Glycosylation analysis.
• Participate in the Client enquiry/project initiation process. Contribute to the generation of Client specific proposals, support of associated conference calls and Client visits.
• Responsible for defining the scope of single assays/techniques, including batch testing, release testing, sample analysis, stability, and assay development, or validations/transfers with the Client.
• In-depth knowledge of regulatory expectations, and section specific techniques and capabilities, in order to advise the client or internal customer.
• Perform and review gap analysis Client methods being transferred in your area of expertise.
• Ability to design standard and non-standard (complex) protocols.
• Knowledge of the client requirements and plan accordingly to meet Client deadlines.
• Ensure Health and Safety information (including GMO risk assessments) are in place and are readily accessible.
• Ability to independently manage complex client requirements and rapidly on-board new client projects.
• Participate in and/or conduct project meetings.
• Attend client conference calls and meetings for specific technical requirements arising during validation, transfer, batch release and stability studies.
• Work across all operational sections and other departments/sub-contractors associated with a specific project to achieve overall milestones.
• Prepare and approve project protocols and amendments. Ensure that the required regulatory, scientific and client requirements are captured.
• Perform content review of standard and non-standard protocols for all assay types e.g. development, validation, sample analysis, release testing etc.
• Ensure assays are performed in accordance with the protocol, Client requirements and Covance Standard Operating Procedures (SOP).
• Coordinate or facilitate the scheduling or management of lab work, where necessary.
• Write validated Analytical Procedures (AP) and Working Documents (WD), and competently review these documents.
• Perform lab work as required.
• Review and approval of regulatory (GMP/GLP/GCP) data.
• Write and approve assay based quality documents – Quality Events, CAPAs, Change Controls, Out of Specification (OOS), and Investigation Reports.
• Perform tracking/trending and subsequent interpretation of assays.
• Identify and communicate adverse events, and advise management on scientific solutions.
• Ability to problem solve unexpected analytical events within projects/assays, and issues within the wider group, and quickly adapt to control new situations.
• Prepare project reports and Certificates of Analysis (CofA), and approve these documents where necessary.
• Ability to make decisions on assay results/data.
• Write and approve assay investigation reports.
• Ability to review and approve complex reports.
• Be aware of the study or assay status at all times and anticipate issues which may affect, quality, time lines etc. To be responsible for communication of the issues to all parties internally and to take appropriate action to resolve.
• Lead in-depth scientific discussions with the client and/or internal customer.
• Ensure all studies are archived in accordance with the current SOP.
• Manage batch testing, release testing, sample analysis, stability, and assay development, or validations/transfers.
• In-depth knowledge of relevant scientific and GMP/GLP/GCP guidelines.
• Act as a Subject Matter Expert (SME) within a QC Section.
• Knowledge of standard and non-standard study designs and the ability to draw scientific conclusions.
• Working method knowledge e.g. instruments used within the laboratories.
• Assist in the preparation/review of training modules in area of expertise.
• Actively support, mentor and develop others in the group, through continuous and consistent feedback.
• Write and review methods (SOPs).
• In-depth knowledge of study process from award to finalisation, archiving and amendments to final reports.
|• The post holder should ideally have a relevant degree and/or 6-8 years industry experience.|
• The ability to get things done by influencing others (both internal and external).
• An up to date knowledge of regulatory guidelines is desirable.
• Knowledge of capabilities and expertise of the Covance organisation and companies that may provide support services.
• Commercial awareness, interpersonal and negotiating skills.
• Learn and maintain knowledge of process excellence processes, tools and activities.
The post holder should typically have:
• Computing skills, including word processing and use of spreadsheets (e.g. Microsoft Office packages and Microsoft Project).
• An in-depth knowledge of health and safety policies, Company policies and procedures, and an in-depth understanding of GMP/GLP/GCP.
• The post holder should be able to communicate effectively at all levels with other Covance employees, as well as external clients, suppliers, etc.
• Several years industry experience in a relevant field.