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Covance

Assay Development Scientist

Covance

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 for 2 Assay Development Scientists for our Biosimilars team. This is part of a scientific team who will be developing methodologies for Biosimilars for our clients. It is a focus area for Covance and an exciting opportunity to be part of a growing and dynamic group based in Yorkshire.

Responsibilities:

  • Has a working knowledge of Biosimilar development ideally and must have an in-depth knowledge of analytical techniques used for antibody/protein analysis. You will engage with internal/external clients on standard and novel methodologies to characterise and set specifications for Biosimilar molecules. Knowledge of higher order techniques would be an advantage. Awareness of new technological advances with the ability to look ahead to new assays or implementation;
  • Work as part of a team to deliver methodologies, liaise with Clients and interpret a wide variety of analytical results;
  • Responsible for on time delivery targets (protocols/results/reports);
  • Will be involved in establishing Development & Establishment scope with Client;
  • Will produce study protocols and reports to meet client and regulatory requirements;
  • Responsible for Gap Analysis as appropriate when Developing/Establishing methods;
  • Involved in start-up and ongoing study meetings;
  • To be aware at all times of study status and anticipate problems that may affect timing, quality etc. and to work with operations taking appropriate action to resolve such problems and prioritise analysis for clients;
  • Provides client feedback to team;
  • Responsible for providing methods post establishment as confirmation of readiness for Qualification etc.;
  • Responsible for set up of appropriate software (Softmax Pro, Empower etc.);
  • Hosts and participates in scientific client visits;
  • Ensures that their individual training records are up to date and accurately reflect their capabilities;
  • Performs any other task as may be reasonably requested by the BioCMC Management.

Required Skills, Experience and Education:

  • Responsible for the efficient development and optimisation of study methods within the relevant group;
  • As required, provide appropriate technical training for staff to develop their skills and the group knowledge base. Should take responsibility for technical aspects of projects undertaken within the group, maintain track of team activity and strive to keep projects on schedule;
  • In depth knowledge of data processing systems;
  • Comprehensive understanding of routine use and maintenance of equipment appropriate to BioCMC, including trouble shooting;
  • To help support equipment qualification within the BioCMC Division. This may include qualification design and protocol preparation.

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 63296BR.

You can also follow the link:

http://jobsearch.covance.com/jobs/1476812-Assay-Development-Scientist-Protein-Chem.aspx

EEO Employer Covance is committed to diversity in the workplace and is an equal opportunity employer. Your confidentiality and privacy are important to us.

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