About LabCorp Drug Development:
As a leading contract research organization, LabCorp provides comprehensive drug development solutions for a range of industries. We are a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Together with our clients, we support the development of innovative, life-changing treatments.
The Role:
Our UK site in Harrogate, is currently recruiting for a QC Scientist to join the CE CMC team.
The CMC business unit; provides dedicated release and stability testing from preclinical phases through the commercial life of a product. The CMC team support method development, transfer, phase appropriate validation & assay establishment of large molecules. We structure ourselves to deliver scientific expertise to our clients; collaborating closely with them to support the development of medicinal products through the drug development process and onto market.
The QC Scientist role within the CMC department is a Senior Scientist position. You will provide technical and regulatory oversight for stability and batch release testing; executed by the laboratory QC Analyst team in a GMP environment. Alternative terminology for the QC Scientist include Study Manager and Lead Scientist
Job Responsibilities:
Acting as the scientific lead in one or more of the following analytical techniques: Capillary Electrophoresis including CE-SDS and cIEF, SDS-PAGE and Compendial Techniques such as pH, Appearance and Osmolality.
Supporting client projects for Stability and Batch Release for Large Molecule products including Monoclonal Antibodies and Vaccines.
Designing method development and validation strategies.
Performing technical appraisal of analytical data against acceptance criteria and study parameters for reporting to the client.
Perform regulatory compliance checks and maintain regulatory oversight during study execution.
Lead technical or regulatory investigations when required throughout the conduct of a project.
Training, mentoring and coaching of laboratory analysts and other team members.
What Labcorp Drug Development can offer you:
A comprehensive onboarding training plan covering laboratory, technical and regulatory training packages.
Unsurpassed career development opportunities, with the ability to develop your technical and managerial skills.
Ability to work with a variety of different clients on wide ranging projects.
Competitive salaries and a comprehensive benefits package including health cover and contributory pension.
Key Information:
Position includes a 6-month onboarding & probationary period during which working hours are 8:45am – 5pm.
The role incorporates both office working and laboratory based activities, with the flexibility to work both on site and at home.
Prerequisites:
Required: Scientific degree (BSc / MSc / PhD or equivalent).
Required: Able to communicate effectively at all levels with internal employees and external clients, with the ability to get things done by influencing others.
Required: Commercial awareness, interpersonal and negotiating skills and able to learn and maintain knowledge of process excellence processes.
Either: Technical expertise in at least one of the following scientific disciplines: Capillary Electrophoresis including CE-SDS and cIEF, SDS-PAGE and Compendial Techniques such as pH, Appearance and Osmolality.
Either: Experience within industry or similar, with study management and client management.
Preferred: An in-depth understanding of health and safety policies and a good understanding of GMP regulatory guidelines.
Labcorp is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
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