Lead Scientist (Biosimilars)
Yorkshire, United Kingdom
COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries.
Due to continued investment and to meet increasing demand from the Biopharmaceutical sector, the BioPharm CMC Solutions group currently has a number of exciting and key job opportunities.
We are expanding our Biosimilar solutions with a dedicated Biosimilars team. The role of the team is to continue to develop our end to end solution, by creating an analytical pathway. There will also be a company drive and support to develop this approach and work with all departments within Covance from Non-clinical, clinical to market access.
We are keen to attract outstanding individuals who have a passion for drug development and in particular, Biosimilar development.
We are currently recruiting a Lead Scientist for our BioPharm CMC department.
About the Job:
Working as part of the Molecule Management Group, the Lead Scientist (LS) within the Biosimilars team will be responsible for developing the scientific rationale and implementation of the Biosimilar strategy within BioCMC. This will require working in a team on multi-technique Biosimilar projects and designing a rationale for linking structural attributes with function and Mode of Action and developing risk assessments.
In this role, the LS will provide internal and external Clients with a central scientific point of contact within BioPharmaceutical CMC Solutions – Large Molecules (BioCMC). The individual is accountable for leading the scientific team to ensure that Client requirements and deliverables are met. This involves discussion with the Client to design Biosimilar proposals, working with the PMO and Development scientists. It will also involve communicating with the QC section managers and oversight of scientific progress of projects to ensure the successful, initiation, planning, execution, monitoring and completion of projects. The LS primary responsibilities will be to navigate the regulatory framework to ensure that the client programs are conducted to meet the defined milestones along the drug development pathway with scientific integrity.
The LS is expected to have a working knowledge of all methodologies for a Client Biosimilar project. They will write protocols and reports using the QC scientist approved data that fulfils the protocol design and all regulatory expectations.
The LS will be required to communicate with internal and external project teams, departmental management and the Client to ensure effective scientific progress throughout the life cycle of a project in partnership with the PMO. The LS will be expected to communicate the scientific and regulatory framework of a project that builds a team to understand and delivers the drug development milestones.
The individual will identify and communicate scientific and regulatory developments to the molecule management team and the wider senior scientific group (Method Development and QC Scientists).
The post holder will report to a Senior Lead Scientist on a daily basis.
The post holder will ensure adherence to the BioCMC SOPs and will be responsible for completion of all relevant documentation.
Yorkshire based position.
Required Skills, Experience and Education:
- The post holder should have a relevant degree and/or PhD;
- Experience of drug development ideally throughout the drug development pathway and particularly of Biosimilars;
- A working knowledge of a wide range of CMC analytical techniques;
- Working knowledge of statistics and it’s application to techniques and regulatory applications (validation, equivalence);
- The ability to get things done by influencing others (both internal and external);
- An up to date knowledge of regulatory guidelines and their application;
- Knowledge of capabilities and expertise of the Covance organisation and companies that may provide support services;
- Commercial awareness, interpersonal and negotiating skills.
How to apply:
If you are interested in a Covance opportunity and would like to apply, please visit our website at covancecareers.com and look for the reference 61505BR.
You can also follow the link:
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