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Job Details

Lead/Senior QC Scientist

Company: Covance
Location: York, UK
Reference: 23703
Closing Date: 16 Dec 18
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

We are currently recruiting for a Senior QC (Lead) Scientist to join the expanding team of BioPharmaceutical CMC Solutions – Large Molecules (BioCMC).

Requirements:

Join our new lab in York, UK!

BioPharmaceutical CMC Solutions – Large Molecules (BioCMC) is expanding and we have opened the doors to our new 17,000ft2 High quality lab near Sand Hutton, York.

 

We are currently recruiting for a Senior QC (Lead) Scientist to join the expanding team.

The BioCMC solutions Division in York will accommodate a variety of Protein Chemistry based analytical techniques, Mass Spectrometry, ELISA & Cell Based Assay. The facilities will also include a Sample management Lab, Stability suite and Cell storage suite.

 

The Covance York facility is based on an attractive 80 acre site on the NAFIC Business Park a few miles north of York and comprises of an On-site Gym, nursery, restaurant & café. There is also parking for Covance employees.

Working as part of the Operations group, a Senior QC Scientist routinely manages large, complex and multi-technique projects including method qualification and validation. In this role, the Senior QC Scientist will provide internal and external Clients with a central scientific point of contact for projects within BioCMC. The individual is accountable for leading the scientific teams to ensure that Client requirements and deliverables are met and to ensure regulatory compliance.

The Senior QC Scientist 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 Senior QC Scientist needs to have an extensive working knowledge of all methodologies for a Client project. They will write protocols and reports using data approved by QC Scientists that fulfils the protocol design and all regulatory expectations. The Senior QC Scientist 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 Project Management Office.

The Senior QC Scientist 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 operational team and the wider senior scientific group (Method Development and QC Scientists). There is an expectation that the senior members of the scientist team will be required to travel to visit clients and attend conferences, and represent Covance by preparing and/or giving presentations and writing scientific papers. The post holder will ensure adherence to the BioCMC SOPs and will be responsible for completion of all relevant documentation.

 

Requirements:

  • The post holder should ideally have a relevant degree/PhD
  • Significant and relevant industry experience in CMC Drug Development.
  • A working knowledge of a wide range of CMC analytical techniques (including experience in  method development and validation)
  • Working knowledge of statistics and its 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  GxP regulatory guidelines and their application.
  • Knowledge of capabilities and expertise of the Covance organization and companies that may provide support services.
  • Commercial awareness, interpersonal and negotiating skills.
  • Learn and maintain knowledge of process excellence processes, tools and activities.
  • Computing skills, including word processing and use of spreadsheets (e.g. Microsoft Office packages and Microsoft Project).
  • Understanding of health and safety policies, Company policies and procedures, and an in-depth understanding of the GxPs.
  • Ability to communicate effectively at all levels with co-workers, as well as external clients, suppliers, etc.

 

keywords: QC, quality control, HPLC, CE & iCE, ELISA, Cell Based Assay, Mass spectrometry, pharmacoepia, chemistry, CMC, CE & iCE, SPR, isoelectric focusing, capillary electrophoresis, GLP,GMP, GxP, large molecules, biochemistry, cell culture, PCR, Molecular Biology, Mass Spec, MS, recombinant, biosimilars, antibody drug conjugates, monoclonal antibodies, Vaccine development, cell therapy, gene therapy, siRNA, Oligonucleotides, batch release, stability, HPLC, Molecular Biology, Virology, QC Scientist, Lead Scientist, Principal Scientist, Senior Scientist.

Apply for this job: Lead/Senior QC Scientist

Contact Information:

Address:  Covance Harrogate
Harrogate

England
Website:  Visit Our Web Site

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