About Instil Bio
The transition from the era of pharmaceuticals to the era of biotechnology brought tremendous medical innovation to patients’ lives. Come join us as we lead the next transition – from biotechnology to cell therapy.
Instil Bio is a rapidly growing and dynamic cell therapy company; we are building the team that will establish cell therapy as the third pillar of therapeutic medicines. Our people work in a highly collaborative, fast-paced environment, marrying our expertise and dedication with our desire to help patients in need. We offer attractive and competitive compensation plans and benefit programs.
Manufacturing Shift Supervisor
We now have an excellent opportunity for a Manufacturing Shift Supervisor to join the production team in Manchester. Reporting to the Manufacturing Manager you will manage and mentor the Cell Therapy Specialists within the Manufacturing function at Instil Bio (UK)’s clinical manufacturing facilities in Manchester, UK. You will lead, develop and manage staff to support the manufacture of clinical and verification batches to meet clinical demand.
What You Will Do
In addition to managing a shift team of Cell Therapy Specialists your role will require regular interaction with the quality team, MSAT and PD. You will also interact with supply chain and warehouse teams to ensure availability of materials.
Specific activities will include:
* Daily management of Manufacturing team to ensure complete, timely and safe production of cell therapy products ready for release.
* Co-ordinate with other Cell Therapy Team Leaders to schedule production activities across all teams
* Review batch documentation in real-time alongside QA to ensure RFT completion of batch records.
* Monitoring batch manufacturing operations for accuracy against instructions, specifications and ensuring records are accurate and documented in a a timely manner.
* Identifying and escalating deviations and ensuring deviations are documented accurately and in a timely manner.
* Support other departments in executing all elements of the Quality Management System (Root Cause, Investigation and CAPA)
* Managing the Sampling Process end to end including interpreting information from QC reports to make process decisions
* Ensuring environmental monitoring of the Clean Room is performed as per the batch manufacturing and defined operational procedures.
* To participate in the review and update of the technical documentation (BMR’s, SOPs, FRM’s, DAT’s etc.) as part of the quality system as required
* To perform or participate in various process validation activities as required
* Ensuring that Manufacturing Team is trained to the required levels according to the QMS & Training Policies for the manufacturing operations performed.
* Monitor adherence to policies, procedures and SOPs to ensure compliance with manufacturing procedures required.
* Work with the validation engineers to assist in the qualification and testing as part of the change control process where required.
* Comply with all site Health and Safety Regulations including following the Health & Safety Policy and work to the associated COSHH and Risk Assessments
Skills & Experience You Will Bring To The Team
To be successful in the role of Manufacturing Shift Supervisor it is likely you will hold a BSc or MSc degree in a Biological Science, Biotechnology, Immunology or related discipline. You will have gained significant experience in a cGMP manufacturing environment and developed the following skills:
* Ability to plan and prioritise own work and work of others
* Development of a small team of highly skilled staff
* Understanding of the role of the MHRA and or FDA in Good Manufacturing Practice
* Understanding of Good Manufacturing Practice
* Degree in Science discipline
* Knowledge of a range of research techniques and methodologies
* Excellent communication skills, written & oral
* Ability to work well with others in the team environment
* Willingness to learn
Whilst not essential it may be considered advantageous if you have:
* Knowledge of cell culture techniques and Aseptic working
* Experience of advanced Cell Therapy Manufacturing for medical use.
* Closed system manufacturing experience
* BSc in Immunology, Molecular Biology or related discipline
* Knowledge of cell therapy, molecular biology and gene transfer techniques or knowledge of immunotherapy field
* A basic understanding of microbiology
Remuneration & Benefits
The salary for the Manufacturing Shift Supervisor will be competitive within the Biotechnology and wider Scientific Sector with actual salary offered reflecting relevant qualifications and experience as well as performance at interview. In any event we anticipate a basic salary in the £40,000 to £45,000 range (plus shift allowance), offered together with an attractive bonus and benefits package.
If you would like to join us as a Manufacturing Shift Supervisor at this critical time in our development and you think your skills and experience are a good fit for this role, apply with a current CV and we’ll get back to you within a day or two.
Salary: £40000 – £57000/annum Attractive Bonus & Benefits
Job Type: Permanent
Location: M13, Manchester, Greater Manchester
To apply for this job please visit www.cv-library.co.uk.