Qc Specialist - Manchester, United Kingdom - Instil Bio

Description

About Instil Bio
Instil Bio is a science driven dynamic cell therapy company on the frontier of revolutionising cancer treatment.

We are changing the course of medicine, drawing on our own research and data to challenge established conventions, pushing boundaries to change the course of medicine.

Transforming the lives of our patients is at the heart of everything we do, they put their trust in us to develop personalised treatments, with the utmost integrity.

Come and thrive in our vibrant, fast paced, open, committed and encouraging culture and make a difference to patients' lives across the world.

QC Specialist
We now have a fantastic opportunity for a QC Specialist to join us at our Manchester site.

Reporting to the Quality Control Manager you will be responsible for performing a range of QC assays, predominantly Flow Cytometry.

Key Duties & Responsibilities

• Responsible for performing, reviewing and recording quality control assays ensuring safety, efficacy, dose and purity of product.
• Performing assays to measure key quality attributes of product including:
• Flow cytometry assays
• Automated cell counting, viability and phenotyping assays
• Endotoxin assays
• Sterility assays
• Perform release testing of raw materials.
• Support instrument and method qualification, verification and validation.
• Authoring and reviewing QC GMP documents (including SOPs).
• Checking and reviewing of data
• Logging and tracking samples provided by Production for QC testing
• Undertake Investigations Deviations, Change Controls and CAPAs

Relevant Education Skills and Experience
As a Quality Control Scientist you will have the following qualifications, skills and experiences:

• QC experience in a pharmaceutical/ Biopharmaceutical industry working in a GMP laboratory.
• Experience in Flow cytometry
• Experience in Cellbased potency assays
• Experience authoring, reviewing, and implementing methods and/or standard operating procedures in the quality control environment.
• Experience in change control, method qualification, validation and/or transfers.
• Excellent interpersonal, verbal and written communication skills

Whilst not essential it may be an advantage if you have experience of:

• Automated Sterility/Endotoxin testing methods
• Knowledge of EMA Eudralex Volume 4 GMP requirements for manufacture of Advanced Therapy Medicinal Products (EU GMP guidelines Part IV))
• MHRA and HTA regulations associated with cell therapy products

Remuneration & Benefits
The salary for the QC Specialist role will be highly competitive together with an attractive, bonus and benefits package.

**Application Process