Job Overview: We are currently recruiting for a QC Scientist to join our growing BIOCMC department in Greenfield, IN. The Bioassay section is focused on the assessment of the biological activity of large molecules using cell-based assays and ELISAs. The accurate determination of the potency 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. Cell-based assays are also used as part of the immunogenicity assessment of the of large molecule drug to detect the presence of neutralising anti-drug antibodies that may be elicited in toxicology and clinical trials trial subjects in response to biological drug administration. A wide variety of cellular, biochemical and ligand/ receptor binding assays are used. The endpoint determinations of these assays include, but are not limited to; Fluorescence, Luminescence, ELISA, Flow cytometry, electrochemiluminescence (MSD) and FRET. Experience of cell culture work /ELISAs coupled with a good background in aseptic technique whilst working in a Class II facility would be advantageous in this section. The Role:
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 be responsible for single projects (for one or several related techniques), may be part of a larger cross-sectional team leading small to medium multi-technique projects (as a molecule lead), or be part of a larger cross-sectional project working in conjunction with a more experienced QC Scientist or Lead Scientist.
Project requirements may include, but are not limited to; assay transfer, validation, sample 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 customers with a central scientific point of contact for techniques within their area of expertise, or for external Clients where the QC Scientist is not the molecule lead. The individual is accountable for effective communication either directly with the Client or via the molecule lead to ensure that Client requirements and project deliverables are met. This includes discussion with the Project Management Office (PMO), molecule lead if applicable, 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 good working 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 work with more experienced QC Scientists or molecule leads to identify and communicate scientific and regulatory developments within their field of expertise, to include QA, management, Lead Scientists, QC Scientists and Laboratory Analysts. The QC Scientist may 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.Education/Qualifications:
- The post holder should ideally have a relevant degree and/or 5-6 years industry experience.
- Computing skills, including word processing and use of spreadsheets (e.g. Microsoft Office packages and Microsoft Project).
- An in-depth understanding of health and safety policies, Company policies and procedures, and a good 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.
- The ability to get things done by influencing others (both internal and external).
- Knowledge of capabilities and expertise of the Covance organisation and companies that may provide support services.
- An up to date knowledge of regulatory guidelines.
- Commercial awareness, interpersonal and negotiating skills.
- Learn and maintain knowledge of process excellence processes, tools and activities.
- Experience will have been gained in similar types of study management (either internal or external).
- Experience of Client Management.
- Technical expertise in an appropriate scientific discipline.