QC Bioassay Scientist- Pharmaceutical -GMP-Iceland-GBP65k-GBP75k

Recruiter
Anonymous
Location
United Kingdom
Salary
65000.00 - 75000.00 GBP Annual + GBP65000 - GBP75000/annum
Posted
11 May 2017
Closes
22 May 2017
Function
Consultant
Contract Type
Permanent
Hours
Full Time
QC Bioassay Scientist- Pharmaceutical -GMP-Iceland-GBP65k-GBP75k-ELISA - GMP - Technology Transfer - QA
A growing bio-pharmaceutical company requires an experienced QC Bioassay Scientist to join its team. You will be working in a state-of-the-art manufacturing facility with some of the best scientists in the industry. To join you will have direct bioassay experience gained within a pharmaceutical or Biopharmaceutical Company.

The role is based at their HQ in Reykjavik, Iceland and as such the salary is inflated to accommodate the increased living costs. Ideally they are seeking an experienced technician who can hit the ground running but still has potential to develop and grow within the business. This is not a management opportunity.

Key responsibilities and work assignments:

Be able to work in accordance with GMP practices, conducting all activities in a compliant manner.
Willing to take on additional activities with little to no supervision
Performing activities above and beyond their responsibilities as and when required

Responsible for performing the following testing;
*Bioassays
*ELISA based binding assays for:
Residual Host Cell Potein
Residual Protein A
Ligand Binding
Residual Hydrogen Peroxide
*Preparing working cell banks using tissue culture techniques
*Microscopy work
*Aseptic practices

Responsible for performing the following activities;
*Support Technology Transfer/Validation testing
*Generating validation documentation
*Notifying line manager of identified deviations
*Initiating and supporting deviations
*Initiating deviations, leading level 1 deviations, and supporting level 2 and 3 deviations
*Supporting OOS/OOT investigations
*Performing routine cleaning, verification and upkeep of laboratory and equipment
*Performing stock checks
*Provide technical training of level I and II scientists
*Actively involved in the preparations for regulatory inspections and directly involved in audit activities
*Reviewing of laboratory documentation, excluding testing paperwork
*Review of laboratory documentation including testing paperwork
*Competent in using of pipettes
*Provide technical support where required
*Complete master laboratory records documentation using GDP
*Performing of any activities required to support testing, e.g. media preparation
*Qualification and optimisation of critical reagents e.g. cell banks, antibodies, reference material, etc.
*Identifying required document changes and updating of quality documentation
*Supporting change controls
*Initiating and leading change control
*Support and oversee activities performed by level I and II scientists as and when required
*Be aware of and comply with current EHS policies

*Communication Skills: Excellent written and verbal communication skills
*Linguistic Skills: Fluent command of the English language, both written and verbal
*Computer Literacy: Proficient in use of a PC and common Microsoft packages such as Word, Visio, Excel
*Organisation and Management Skills: Will be required to participate and make positive contribution to team meetings. Responsible for individual performance management.
*GMP GDP Experience: Will be expected to work to and comply with the requirements of QMS cGMP and GDP Practises and Policies. Will participate in self inspections and regulatory inspections

Qualifications:

*Education: Minimum of a BSc in a relevant scientific discipline and direct industry experience, or 4 years' experience in Pharmaceutical or Biopharmaceutical sector.

*Experience: Knowledge and proven experience of working to GMP standards