- Contract Type
United Kingdom - M4 Corridor
TalentSource Life Sciences is currently searching for an experienced Principal Scientist to join one of our biotechnology partner companies in the UK. This is an office based position along the M4 corridor and we are able to consider both permanent employees and freelancers.
The successful candidate will be working on studies dedicated to one client. We are looking for someone with strong project management skills with Phase I studies, who is able to act quickly, make well considered decisions and provide solutions.
TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your TalentSource Line Manager who will work closely with you to support your professional development and growth.
Job specific tasks and responsibilities:
- Design and execution of the bioanalytical strategy (Pharmacokinetic, Immunogenicity and Biomarker)
- Assure bioanalytical tasks are executed with good scientific quality, on the relevant quality system and within the agreed timelines. Oversee the execution by internal facilities or external vendors.
- Departmental representative in multidisciplinary project teams
- Collaborate with multiple internal and external stakeholders (therapeutic area, quantitive clinical pharmacology, clinical operations, non-clinical safety, contract research organisations, etc.) to build and execute the bioanalytical strategy
- Partipcate 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). Support scientific advice meetings with regulatory authorities (EMA, PMDA, FDA)
- Oversee the writing of the Immunogenicity Risk Assessment
- Particpate in vendor governance through technical and study audits
- Compliant with GLP, GcLP, GCP
Education, Qualifications & Experience:
- Bachelor's Degree in Life Sciecnes or equivalent. Master's or PhD is preferred.
- Extensive experience in the pharmaceutical industry or a CRO, supporting regulatory bioanalysis of large molecules
Skills & Knowledge:
- Extensive knowledge of a range of bioanalytical techniques including LC-MS/MS, Immunoassay, flow cytometry and quantitive PCR to support the analysis of Pharmacokinetics (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 the FDA and EMA
- Previous experience managing CROs
- Demonstrated ability to collaborate in and influence multidisciplinary teams
- Expeirence with multispecific NBEs (beneficial)
If you would like to apply, please visit https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00001419
Why TalentSource Life Sciences/CROMSOURCE?
CROMSOURCE is a family-owned, high quality ISO-certified international provider of outsourced services to the pharmaceutical, biotechnology and medical device industries. Since 1994, we have been supporting our clients with outstanding clinical research and staffing solutions services. TalentSource Life Sciences is a fully dedicated flexible resourcing unit within CROMSOURCE and the successful growth has been achieved by putting high quality and client focus at the heart of everything we do.
Our employees are the most valuable company asset and we value resources and ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology.
Our approach is to equally value our clients and our own people. We know that we are not simply providing 'staff' or 'resources'. We are providing expert people. Highly talented, well trained, motivated people who make a positive difference to the work of our clients every day. Together we help our clients succeed in their work developing medicines and medical devices for patients around the world. Our large management team consists of a people with an extended experience within pharma and a high level of market knowledge. We our open, friendly and approachable and aim to support you through the recruitment process every step of the way.
As this position is client-facing, the successful candidates must be confident and be able to drive the role and themselves and to work autonomously in close liaison with a line manager at TalentSource, who will provide you with mentoring and guidance.
To ensure the success of our clients, our team of international professionals is focused on continuous improvement. We invest in our employees by providing the coaching and training necessary to deliver high quality services for our clients.
Every day we strive to create an environment in which all employees can contribute to their full potential and at the same time allow the company to develop and grow with them. With CROMSOURCE you will be able to participate in exciting projects and achieve your professional goals.
Keywords: Principal Scienitist, Scientist, Bioanalytics, Bioanalytical Scientific Manager, Bioanalytical, Biomarker, Pharmacokinetic, Immunogenicity, NBE, PCR, Immunoassay, CRO, Contract Research Organisation, Outsourced, Biopharmaceutical, Biopharma, Permanent, Contract, Temporary, Freelance