QC Scientist-Biodistribution

Job Overview:

Are you looking to join an expanding team with scientific leadership opportunities? Does the field of cell and gene therapy pique your interest? Do you enjoy a variety of scientific methodologies and bringing medicine to patients? If so, then we might have the right career opportunity for you!

Our Greenfield Labcorp site is currently recruiting for a QC Scientist to join the Biopharmaceutical Chemistry Manufacturing Controls (CMC) division. The CMC division provides end-to-end analytical solutions and testing services to ensure quality control of our clients manufactured drug products. We work with leading pharmaceutical and biotech clients to ensure that their manufactured drug product or API (Active pharmaceutical Ingredient) passes all quality testing. Once this testing is complete, it brings our clients one-step closer to successfully launching that drug product on the market.

The QC Scientist will join the expanding Biodistribution/Molecular Biology team in the CMC division and will be responsible for managing and directing studies on behalf of our Clients for analytical testing of key cell and gene therapy molecules. Job responsibilities are similar to that of a Study Director (GLP) or Responsible Scientist (GCP), and the appropriate candidate would be expected to deliver results in a fast paced environment. The team works on all aspects of the drug life cycle, from research and development through to commercial release material. We support biodistribution, persistence and shedding studies, clinical trials and stability material for our Clients in our dedicated PCR and virology suites. The ideal candidate should have a good working understanding of GLP and GCP regulations within this field and 5 years' experience within industry or a CRO would be preferred.

• Participate in and/or conduct project meetings.
• Attend client conference calls and meetings for specific technical requirements arising during projects.
• Prepare and approve project protocols and amendments. Ensure that the required regulatory, scientific and client requirements are captured.
• Ensure assays are performed in accordance with the protocol, client requirements and Labcorp Standard Operating Procedures (SOPs) and policies.
• Coordinate or facilitate the scheduling or management of lab work, where necessary.
• Where appropriate, write or manage protocols, Client Methods, Working Documents (WD), and competently review these documents.
• Review and approval of regulatory (GLP/GCP) data.
• Write and own (where appropriate) assay based quality documents - Quality Events, Risk Assessments, CAPAs, Change Controls and Out of Specification (OOS).
• Perform tracking/trending and subsequent interpretation of assays and feedback to Operations and Clients as appropriate.
• Identify and communicate adverse events to management, and provide support in the resolution of these events.
• Prepare project reports and approve these documents.
• Accountable for QA and Client comments on Protocols and Reports where necessary.
• Ability to make decisions on assay results/data, with guidance from an experienced QC Scientist or Lead Scientist where necessary.
• Write and approve assay investigation reports.

Education/Qualifications:

• The post holder should ideally have a relevant degree and/or 3 to 5 years relevant industry experience.

Experience:

• Computing skills, including word processing and use of spreadsheets (e.g. Microsoft Office packages and Microsoft Project).
• An understanding of health and safety policies, Company policies and procedures, and an understanding of GLP/GCP.
• The post holder should be able to communicate effectively at all levels, with other Labcorp employees, as well as external clients, suppliers, etc.
• The ability to get things done by influencing others (both internal and external).
• Up to date knowledge of regulatory guidelines.
• Knowledge of capabilities and expertise of the Labcorp organization and companies that may provide support services.
• Commercial awareness, interpersonal and negotiating skills.
• Learn and maintain knowledge of process excellence, tools and activities.