Principal Scientist - Immunoassay

This role is based at Fordham, Cambridgeshire, UK within Drug Development Solutions (DDS). 

With one of the world’s largest bioanalytical centres, recognised for leadership in science and technology, DDS has comprehensive capabilities for pharmacokinetic, immunogenicity and biomarker measurement that span LC-MS/MS, immunoassay and flow cytometry.  We routinely solve difficult method development challenges and have the capacity to support the largest, most complex protocols. Our Bioanalysis Department works together with pharmaceutical and biopharmaceutical companies in support of pre-clinical and clinical trials for a wide variety of clients and therapeutic areas. We use innovative analytical methodology and the expertise of our analytical scientists to speed up the discovery of new medicines. The Department operates a well-equipped laboratory compliant with GLP and GCP, and offers the opportunity to work with state of the art analytical instrumentation.

The Job (Principal Scientist - Immunoassay)

In this role, you will be a technical expert in scientific technology and experimental practice with peer recognition and credibility, and have a track record of publication in peer-reviewed journals and ability to present externally.  The Principal Scientist has an ability to adopt and adapt new technology, tackle challenging method development activities, and is an active contributor to the company’s Scientific Strategy. Alongside, you with provide mentoring and technical support to internal colleagues in operations and in addition contribute your expertise to business development activities to facilitate building strong relationships with new and existing sponsors.

Key responsibilities include;

  • Serve as the scientific lead of the immunoassay bioanalysis team, responsible for driving scientific strategy of the group
  • Be the SME for preclinical and clinical biopharmaceutical PK/PD/ADA assays
  • Lead, and/or contribute to, complex method development or troubleshooting activities at the bench, alongside providing technical supervision in solving method-specific issues
  • Work closely with external stakeholders in discussions related to biomarker data context of use and ensure supporting analytical methods are fit for purpose
  • Drive scientific and technology innovations for PK/PD/ADA immunoassay services
  • Act as peer reviewer for method development and validation studies, and demonstrate robust scientific decision making to ensure work is completed to regulatory compliance and upmost scientific rigour
  • Ensure SOPs, protocols, policies and procedures are up to date with regulatory guidelines or latest industry thinking
  • Actively work with the Business Development team in the preparation of client proposals and support them to meet with new customers and seek out new business
  • Drive a culture of continuous improvement and lean working practices within the team
  • Build strong partnerships with our customers to help them progress their drug development pipeline
  • Be able to lead scientists through the method development process and coach/mentor junior scientists through a technical career path
  • Present on and publish the science at external conferences and in peer-reviewed journals, to build the scientific reputation in the wider community.

The ideal candidate will;

  • Be enthusiastic, proactive, flexible and driven to go the extra mile to find solutions to our customers problems
  • Focus on quality, and possess an excellent attention to detail
  • Communicate effectively; explaining the outcome of experiments to team members and customers

It would be an advantage to have;

  • PhD in biological science, or relevant discipline
  • Experience of Line management, coaching or mentoring
  • Experience in a GxP accredited or clinical laboratory is advantageous
  • Excellent communication skills evidenced by external presentations
  • Willingness to travel if needed

 

Life At Fordham

We have a state of the art purpose built facility within an open green countryside setting, with places to walk and relax outdoors, as well as a café on site.  At Fordham, we have friendly collaborative teams, dedicated to helping our customers to achieve their goals.  Every day is different; we are empowered to solve a range of scientific problems, and embrace continuous improvement.  Individually, and together, we take responsibility to progress projects, learn, and share best practice.  We help one another to progress and grow.  Together we build strong scientific teams, who celebrate success and make time to have fun.   We take care of our people, environment and community.

Benefits

  • Flexible Working: we offer a flexible approach to work where you can adapt your working pattern to balance your home and work needs
  • Defined career progression, mentoring and support is offered, and personal development is encouraged
  • Excellent training and development opportunities for all employees
  • Wide range of flexible benefits, including a group personal pension plan, access to private medical care, cycle to work scheme, travel insurance and more
  • Regular organised social activities; summer fair, Christmas party, occasional food truck visits and other ad-hoc events and celebrations

Education, experience and technical skills:

  • Degree in biological science, or equivalent.
  • Experience working within the pharmaceutical or CRO industry with good understanding of the drug development process
  • Expertise in developing methods to support validation of PK/PD/ADA endpoints using platforms such as MSD, Gyrolab, ELISA and Quanterix.
  • Thorough understanding of GLPs, GCLPs, and regulatory guidance’s
  • Accomplished data interpretation experience and knowledge of statistical approaches for analysing biological data
  • Excellent English spoken and written
  • Excellent attention to detail – reviewing data, plans and reports, and assisting with peer reviews and audits
  • Bachelors degree in biological sciences and relevant industry experience. 
  • PhD would be a distinct advantage
  • Min 5 years of experience in pharma/biotech/CRO
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