Study Manager - Immunology

Overview

Study Manager - Immunology

If you are a talented Scientist who has experience in a wide range of assay techniques, technical understanding of a wide range of methodologies and the ability to work independently on exciting projects then this might be the role you have been waiting for!

Work in a family friendly and flexible environment where part time hours are an option!

Role responsibilities

• Experimental expertise in at least one scientific area encompassing multiple techniques.
• Capable of training junior staff to a high level of competence.
• Advanced data analysis skills across a broad range of techniques.
• Clear understanding how assay design impacts data interpretation across a broad range of techniques.
• Application of high-level technical knowledge to assay development, qualification and validation.
• Guide Customers in making the best decisions for assay design and data interpretation.
• Lead complex development studies across a range of technical areas.
• Identify the relevant technical resources required to design and develop complex assays
• Independently manage studies including study planning, scheduling, preparation and review of documentation, and customer communication, with support from the Project Lead and/or Senior Study Manager.
• Prepare protocol, reports and proposals for a wide range of studies, include complex development and qualification studies.
• Be able to lead Customer discussions and advise on complex challenges that may arise during a customer study.
• Support the commercial team in preparing proposals and contracts.
• Contribute to discussion on research and development projects where appropriate.
• Ensuring adherence to Good Documentation Practices resulting in completed documents, which require minimal revision upon review.
• Performance of technical review of a wide range of documents including, but not limited to, analytical procedure and laboratory documentation
• Design and implement process improvements ensuring that the studies are operationally efficient to enable the continuous improvement of study management and to simplify and optimise procedures.

Person specification

• Experience in the management of a broad range of customer studies within a contract research organisation or equivalent.
• Good knowledge of the analysis of biopharmaceuticals and application of ICH guidelines.
• Previous experience in assay development or academic research
• Degree in a relevant field with significant laboratory experience or equivalent relevant experience.
• Technical competence in a range of bioanalytical and immunological methods.
• Ability to analyse data generated from multiple assay platforms.
• Strong interpersonal skills.
• Flexible working attitude.
• Good organisational and planning skills.
• Good interpersonal skills.

Next Steps

Apply in the first instance online or by contacting Nichola Price at or on .

Equal Opportunities

FPSG is committed to equal opportunities regardless of gender, race, disability, sexual orientation, religion or belief and age.

We are Disability Confident and neurodiverse aware. If you have a disability, please tell us if there are any reasonable adjustments we can make to assist you in your application or with your recruitment process