Method Development Assistant

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 largest UK site in Harrogate, is currently recruiting for a Method Development Assistant to join the Molecular BioA group performing a number of techniques with a key focus on PCR & Extractions.

The Molecular BioA team provides analytical solutions and testing services in support of non-reg, preclinical and clinical projects. The Method Development role, within this method development team, will primarily be responsible for the development/ transfer, and validation of analytical methods within Molecular BioA.

Job Responsibilities:

• Responsible for the efficient development and optimisation of analytical methods within Molecular BioA, in accordance with Sponsor requirements and associated protocol and procedures.
• Monitors assay performance in support of implementation post development
• Participates in Sponsor meetings and contributes to scientific discussion
• Has appropriate knowledge of analytical techniques applied to a given study, is aware of new technology developments and has the ability to support their implementation. Has knowledge of set-up and use of software for data processing as a component of MD (Thermo Sample Manager, QuantStudio, Softmax Pro, etc). May provide technical training for staff across Molecular BioA.
• May be involved in advising on the MD and validation scope for proposed studies. Demonstrates knowledge of Sponsor requirements and works with all project stakeholders to plan accordingly
• Responsible for on time delivery targets. Anticipates study start, manages status and issues that could affect scheduling or quality, and takes appropriate actions; maintains awareness of potential for work scope change as well as the status of additional project components led by other team members. Provides feedback to study stakeholders and takes appropriate action to resolve issues.
• Accountable for creating and maintaining study documentation (including MD Protocols, Analytical Procedures or Methods, Working Documents and MD Reports), in compliance with Labcorp process, SOPs, data integrity policy and relevant regulatory guidelines (CLIA, GxP, ISO). Demonstrates respect for data protection and Sponsor confidentiality. Ensures data is archived in a timely fashion.
• Demonstrates high standards of personal and scientific integrity
• Demonstrates regulatory compliance by maintaining Training Record, ensuring that appropriate policies/ SOPs are read and that training and CCLs are in place, up to date and accurately reflect his/ her capabilities.
• Performs any other task as may be reasonably requested by the Molecular BioA Management.

What LabCorp Drug Development can offer you:

• A comprehensive training plan; with the ability to develop your technical and managerial skills.
• Unsurpassed career development opportunities.
• 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.

Education/Qualifications:

• Scientific degree (BSc/MSc/PhD or equivalent).

Experience:

• The successful candidate is expected, at a minimum, to have a degree in a relevant scientific subject and to have a minimum of 2 years’ experience working with biopharmaceutical products ideally in a regulated environment.

• Ideally the candidate will have experience of analytical techniques including PCR & Extractions

• Experience of working in a CRO environment with knowledge of UK/ OECD GXP regulations would be an advantage.