QC Cell Bank Analyst
Grade – 30
Post Ref – QC0006
Salary – £22,450 – £28,063
Fujifilm Diosynth Biotechnologies based in Billingham, Stockton-on-Tees specialise in developing and executing manufacturing processes for customer’s 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 the Fujifilm Diosynth Biotechnologies global vision is to be the leading and most trusted global Contract Development and Manufacturing Organisation partner in the biopharmaceutical industry.
The role is for a QC Analyst to work as a member of a dedicated QC cell bank team, reporting directly to the QC Cell Bank Manager. The Cell Bank team forms part of the FDBK QC Technical Group and is an integral revenue stream for the Analytical Services Group (ASG).
Within the ASG function, the team is responsible for contract storage and stability testing of GMP microbial and mammalian cell banks. The cell bank team also have site-wide responsibility for the release testing of all newly manufactured GMP microbial and mammalian cell banks as well as ensuring that, incoming customer cell banks to be used in GMP processes meet strict quarantine and release tests.
The main responsibilities of this team are detailed below:
- GMP compliant Cell Line Characterisation (CLC) of Microbial and Mammalian cell banks, covering host systems such as E.coli, Pichia, Saccharomyces and CHO.
- ICH compliant storage and stability trial of GMP cell banks, including at ultra-low freezer temperatures and liquid nitrogen.
- Batch documentation for quality control of GMP cell bank manufacture including QC docs, specification rationales, Certificate of Analysis etc
- Review and approval of customer release data prior to arrival of all external cell banks into the FDBK GMP storage facility. This include working closely with QA and other technical departments to ensure external data are consistent with regulatory and FDBK requirements.
- Management of Outsourced testing activities for cell banks including regular technical call, project meetings and escalation of testing delays to site management to minimise impact on milestones and disposition timelines.
- Site-wide management and maintenance of GMP cell banks including client dispatches, vial issuance for technical use or GMP inoculum provision.
Successful applicants would ideally have some or all of the experience below:
- cGMP analytical activities (good documentation practices)
- A Microbiology /Biotechnology Graduate or to have a good understanding of Microbiological techniques with at least 2 years of experience in this field.
- Aseptic handling/technique
- A proven ability to follow methods.
- Project ownership/planning.
This position provides an excellent opportunity for applicants who want to further expand their microbiological or biotechnological skills in a fast paced but enjoyable and informative environment.
We offer a generous benefits package including;
- Competitive salary plus company bonus scheme
- Up to 35 days of holiday, plus bank holidays.
- BUPA healthcare cover
- Salary Sacrifice scheme offering cycle-to-work, technology scheme, dental plan 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 15th March 2019. 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.