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QC Scientist Bioassay

Location
Harrogate, Yorkshire
Job Type
Permanent
Posted
6 Sep 2022

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 Bioassay 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: ELISA & Cell Based Assays.

  • 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: ELISA, or Cell Based Assays.

  • 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, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.

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Details

  • Job Reference: 705279992-2
  • Date Posted: 6 September 2022
  • Recruiter: LabCorp
  • Location: Harrogate, Yorkshire
  • Salary: On Application
  • Sector: Science & Technology
  • Job Type: Permanent