Band 7 B7 Senior Scientist JD; PDF, B

Key Details

Location:

Royal Free Hospital, Pond St, London, NW3 2QG

Contract:

23 months (Fixed term)

Hours:

Full time – 37.5 hours per week
Salary: £54,320 – £60,981 per annum (Band 7, Grade B7)

We are currently looking for a Senior Scientist to lead the quality control of Cell Therapy products, including a human embryonic derived product, in collaboration with a large pharmaceutical company. The role will focus on establishing and maintaining GMP Quality Control for release testing and stability studies. Extensive flow cytometry experience, particularly with FACSLyric to GMP level, is required.

• Assist/lead in the preparation and review of GMP documentation (BMRs, SOPs, Change Control, user requirement specifications, process deviations, risk assessments).
• Perform ATMP quality control for clinical trials, ensuring compliance with GMP regulatory and quality standards.
• Coordinate QC scheduling, labelling, packaging and distribution of starting materials, raw materials and final drug product.
• Ensure appropriate and timely sampling and testing of raw materials, in‑process samples and finished product.
• Maintain a QC laboratory environment suitable for the manufacture of ATMPs.
• Provide flow cytometry support to other users of the CCGTT.
• Coordinate external testing activities.

• Knowledge and experience with ATMP GMP QC (minimum 2 years).
• Flow cytometry expertise.
• FACSLyric experience to GMP level (minimum 1 year).
• Supervisor experience (desirable).
• MSc in a relevant field (essential).
• Stability studies and GMP requirements knowledge.
• Experience writing QMS documents.

• Essential criteria:
  Knowledge and experience with ATMP GMP QC (at least 2 years), flow cytometry expertise, FACSLyric experience to GMP level (1+ year).
• Desirable criteria:
  Supervisor experience.
• Education:
  
  MSc in a relevant field.
• Skills:
  
  Stability studies and GMP requirements, knowledge of writing QMS documents.

Everyone is welcome at Royal Free London NHS Foundation Trust. We are proud of our diversity and continue to undertake new initiatives to advance equality for LGBT+, BME, gender equality, staff carers and people with disabilities and lived experiences.

Applications are welcome from people wishing to job share or work flexible patterns. We are committed to equal opportunities. Due to the high number of applications, the vacancy may close before the advertised closing date. Only candidates who demonstrate how they meet the person specification will be shortlisted.

Name:
Usha Agarwala

Job title:

Head of Quality Control
Email address: [email protected]

Vaccination:
We encourage staff to get COVID‑19 vaccine and booster doses. Apprenticeship training may be available. Applications from job seekers requiring sponsorship are welcome. All personal data may be transferred to NHS organisations and managed through our electronic systems. A DBS check will be required.