Biopharmaceutical Subject Matter Expert

  • Salary: Competitive
  • REF Number: 00033635
  • Consultant: Jocelyn Blackham
  • Contact: 01438 723500
  • Date Published: 21.08.2015
  • Closed Date: 14.09.2015
  • Sector: Pharmaceutical
  • Location: Home Counties
  • Discipline: Qa/Validation

Jocelyn Blackham at CK Science is currently recruiting for a Biopharmaceutical Subject Matter Expert to join a global pharmaceutical company based in Berkshire. This role is offered on a full time temporary basis for 18 months.

Your main responsibilities in this role will be to:

  • Be accountable for the technical supervision of biopharmaceutical manufacturing activities performed at Contract Manufacturing Organisations (CMO's)
  • Assist in the development of all technical documents required for the Technology Transfer
  • Provide full technical support on biopharmaceutical products
  • Write and review all relevant supporting technical documentation, e.g. plans, protocols, reports as well as sections of CMC Regulation dossier
  • Provide technical support to the Quality Assurance staff for the assessment of change controls, unplanned events, impact assessments, CAPAs and out of specification (OOS) investigations
  • Keep abreast of current best practices and important advances in the field of biopharmaceutical manufacturing

You are required to have the following qualifications, skills and experience:

  • MSc in a life science discipline (or equivalent)
  • Hands on experience supporting cGMP manufacture of Biologics Drug Substance and Drug Product
  • Solid experience in technology transfer of Drug Substance manufacturing processes

If you are employed by this client you will be joining a global pharmaceutical company based in Berkshire. For more information or to apply for this Biopharmaceutical Subject Matter Expert position please contact Jocelyn on +44 (0)1438 723 500 or email Alternatively, please click on the link below to apply online now.

CK Science is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference ST33635 in all correspondence.

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