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We currently have a great opportunity for an experienced scientist to join a leading life sciences company based in the Cambridgeshire area as a Senior Scientist / Study Director. We are looking for a candidate with experience of immunoassays or flow cytometry to join and take responsibility for the management of analytical studies / phases of studies for the development of biopharmaceuticals in the capacity of a Study Director or Project Manager, ensuring that all work is conducted in accordance with the Protocols, Plans, SOPs and appropriate regulatory standards (GLP/GCP).
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Senior Scientist / Study Director will be varied however the key duties and responsibilities are as follows:
1. Protocol and Plan preparation and amendment, and File Note preparation. Scheduling of the work (in conjunction with the Team Leader) and maintenance of Master Schedule
2. Analytical method preparation, development and validation for the analysis of biopharmaceuticals. This could include flow cytometry, immunoassays or clinical analysers. You will also be expected to QC check and interpret analytical data.
3. Ensure all work is conducted in accordance with the Protocol/Plan, SOPs and appropriate regulatory standards (GLP/GCP). You will be expected to respond to comments from the Quality Assurance department, prepare reports / SOPs and archive studies.
4. The role of Senior Scientist / Study Director will be client facing and you will provide study progress to sponsors, manage day-to-day activities of assigned studies and attend sponsor meetings.
To be successful in your application to this exciting opportunity as the Senior Scientist / Study Director we are looking to identify the following on your profile and past history:
1. Relevant degree in a life sciences related discipline, plus previous experience working in a client / customer facing role within a scientific industry environment. Ideally you will have gained experience acting as a Study Director for GLP studies.
2. Proven industry experience in at least one of the following techniques: Flow Cytometry, ELISA, Clinical Analysers. This experience should have been gained working in a GLP environment.
3. Working knowledge and practical experience with method development and method validation.
Key Words: GLP | Study Director | Study Manager | Senior Scientist | Method Development | Method Validation | Biologics | Biopharmaceuticals | immunology | immunoassay | flow cytometry | clinical analysers
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer that is happy to welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors and is made up of a collaboration of scientists supporting science. We look forward to helping you with your next career moves.