QC Analyst / Lead Analyst / Senior Analyst
Grade – 30-32
Post Ref – APR0818a
Salary – £22,450 – £35,512
Fujifilm Diosynth Biotechnologies based in Billingham, Stockton-on-Tees specialise in developing manufacturing processes for customers biologic drugs and offering stability studies to support customer drug substance and drug products.
With plants in Billingham, UK, North Carolina, USA and Texas USA our global vision is to be the leading and most trusted global Contract Development and Manufacturing Organisation partner in the biopharmaceutical industry.
As we continue on a period of significant growth we have an opportunity for a QC Analyst to join the Company.
An exciting vacancy has become available to be a part of the newly created Validation team that will be placed within the QC Technical group. This new post as either analyst/Lead analyst or Senior analyst (depending on experience) will report to the QC analytical project lead and work alongside the Analytical Development (AD) group.
Key Duties and Responsibilities of the Validation team:
This team will work alongside the Analytical Development team to perform analytical RAPTA
(FMEA) assessments, to support EMQ (Robustness) studies and to conduct the formal
analytical validation piece for late phase projects.
This team will support the QC/QA effort associated with large analytical validation programs.
Individuals within this team will form the departmental expertise in product assay validation and
may represent the work conducted in support of analytical validation/PPQ campaigns at audit
Successful applicants would ideally have some or all of the experience below:
Biology/Microbiology/Chemistry related Degree or 2 to 5 years relevant experience
Comprehensive understanding of Biological/microbiological/analytical Chemistry techniques
Experience in cGMP analytical activities
Ability to follow methods
Experience in project ownership/planning
Experience in the qualification/validation of analytical methods
Excellent written and verbal communication skills
Ability to write protocols /reports
We offer a generous benefits package including;
- Competitive salary plus company bonus scheme
- Up to 35 days of holiday, plus bank holidays.
- Salary Sacrifice scheme offering childcare vouchers, bikes, dental etc.
- Free parking.
- Generous pension scheme
For further information please see attached Job Description and Person Specification.
Interested applicants must complete an application form and send to HR no later than 12 noon on Friday 12th October 2018. firstname.lastname@example.org
If we have not contacted you within four weeks of the closing date, please assume that you have not been shortlisted on this occasion.