- Entry level
- No Education
- Salary to negotiate
Location: London or Brussels
We have an exciting opportunity for an Interim Bioanalytical Scientific Manager to work for an expanding, international biopharmaceutical company. The role can be based in the UK (South East, M4 Corridor) or Brussels, Belgium. The contract is for 9 months, but can be extended.
Our client is a global Healthcare giant that develops, manufactures, packages and distributes over-the-counter and prescription pharmaceuticals, nutritional products, active pharmaceutical ingredients and consumer products. They are now expanding their Bioanalysis department which is responsible for the design and execution of bioanalytical strategies throughout the whole portfolio and form the drug discovery to the drug development and post-marketing stage.
Role and Responsibilities:
- Accountable for the design of the bioanalytical strategy and the execution thereof (Pharmacokinetic, Immunogenicity and Biomarker)
- Assures bioanalytical tasks are executed with good scientific quality, within the adequate quality system, and within the agreed upon timelines. This entails overseeing the execution by internal facilities or external vendors.
- Departmental representative in multidisciplinary project teams
- Collaborate with multiple internal and external stakeholders (therapeutic area, quantitative clinical pharmacology, clinical operations, non-clinical safety, contract research organisations, …) to build and execute the bioanalytical strategy
- Participate in preclinical study design and documentation, and in clinical study design and documentation (lab manual, protocol, SAP,…)
- Support regulatory document writing (IB, IND, scientific advice). Supports scientific advice meetings with regulatory authorities (EMA, PMDA, FDA)
- Oversee the writing of the Immunogenicity Risk Assessment
- Participate in vendor governance through technical and study audits
- Compliant towards the adequate quality systems (GLP, GcLP, GCP).
Skills and experience:
- Experience in the pharma or CRO industry supporting regulatory bioanalysis of large molecules
- Extensive knowledge of a range of bioanalytical techniques including LC-MS/MS, Immunoassay, flow cytometry and quantitative PCR to support the analysis of Pharmacokinetic (NBE), Immunogenicity and Biomarker endpoints
- Extensive knowledge of the latest regulatory standards required for GXP studies including international guidance’s published by regulatory agencies such as FDA, EMA
- Previous experience managing contract research organisations
- Demonstrated ability to collaborate in and influence multidisciplinary teams
- Experience with multispecific NBEs is a plus.
To apply for this role, please register on this web site. My team and I would welcome a phone call in private if you would like to explore this role and opportunity, then please contact either myself, Theo Moore, or my colleague Matt Greig, in the London office on +44 (0)20 7801 3384, or at any time during evenings on +44 (0)7918679405.
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