Senior MSAT Scientist

We are looking for a driven individual to join us as a Senior MSAT Scientist.

We are RoslinCT, a world-leading cell and gene therapy contract development and manufacturing organisation creating cutting-edge therapies that change people’s lives. Collaborative, dedicated and talented people are at the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilising ground-breaking science.

As part of our continued growth, we are now recruiting across all of our teams including this Senior MSAT Scientist role. This role is well suited to an individual with experience in cGMP Biologics Manufacturing, ideally within cell and gene therapies, looking to apply their knowledge to an industry-leading, growing organisation.

The Role:
As a key member of our MSAT (Manufacturing Science & Technology) team, you will work with the RoslinCT Development & Manufacturing teams, in addition to our clients, to provide technical support for cell and gene therapy Manufacturing process technology transfers, process improvements and quality investigations in addition to providing real-time on the floor technical support in our cleanrooms.

The ideal candidate will have experience in cell and gene therapy cGMP Manufacturing, although this is not essential.

Responsibilities:
Work at RoslinCT is fast paced, and no two days are the same. Your responsibilities will therefore be varied, and will include;
* As part of the wider MSAT team, delivery of a variety of assigned cell and gene therapy Manufacturing technical projects and tasks ensuring project timelines are met.
* Implementation of new processes and products, including process descriptions, from our clients and the RoslinCT Development team into RoslinCT’s Manufacturing facilities.
* Undertaking of facility gap assessments, and supporting the completion process, for incoming Manufacturing projects and initiation of subsequent required actions to support successful process transfers.
* Writing of process change controls, validation protocols, risk assessments, batch records and other relevant documentation for ongoing and new Manufacturing processes.
* Development of new technical protocols, SOPs and related technical documentation for technology transfer and development of Manufacturing projects.
* Completion of GMP material assessments and finalisation of the bill of materials.
* Management of a process monitoring programme to proactively identify and react to out of trends and shifts in Manufacturing process performance.
* Provision of cross-functional technical support and collaborative work with the Development, QC, QA and Supply Chain teams.
* Co-ordination of evaluation and adoption of new cell and gene therapy Manufacturing technologies.
* Provision of training to Manufacturing staff on any new Manufacturing processes transferred into cell and gene therapy Manufacturing.
* Support in technical investigations and generation and approval of technical reports to support close-out of deviations and troubleshooting of issues.
* Identification of trends in data reviews and collation and analysis of batch data for preparation of client process summary reports.

Qualifications:
You will hold a Life Sciences degree or equivalent relevant experience.

Skills and Experience:
You will be able to demonstrate:
* Experience in GMP Manufacturing within the Biologics (and/or cell and gene therapy Manufacturing) sector.
* Experience working with cGMP systems and UK/EU/FDA regulations for medicinal products.
* Experience writing technical documentation such as process change controls, validation protocols, batch records and SOPs.
* Previous hands-on experience of GMP cell and gene therapy Manufacturing processes and/or with iPSC lines or human progenitor cells would be desirable but not essential.

Benefits:
In addition to a competitive salary and the opportunity to join an exciting, rapidly expanding company delivering life-changing therapies, we offer:
​* 31 days of annual leave, plus 4 public holidays - when you have been with us for three years, we will give you an extra day holiday and when you reach 5 years, you’ll get an extra two days’ holiday.
* Competitive company pension scheme – we contribute up to 8% of your salary (depending on length of service) to ensure that you are all set for the future.
* Group Life Cover – you are automatically covered for three times your basic salary to give you peace of mind for you and your family.
* Healthcare Cashback, Mental Health/Wellbeing support and gym discounts via our Healthcare plan.
* Staff discounts on food, drink, electronics, entertainment and electricals.
* Access to our Cycle2Work Scheme so you can save up to 42% on a new bike to help with your commute and wellbeing.
* We have a dedicated Social Committee and other regular company events such as BBQs, team drinks, quizzes, parties and 5-aside football.
* Career Progression & Training Opportunities are provided for all of our staff to help you achieve your goals and grow professionally and personally.

Values:
A key part of working at RoslinCT is being able to embody our company values, which are integral to the work we do here. As such, you should be able to demonstrate:
* Passion for customer satisfaction.
* Ability to support a ‘one team’ approach.
* Great communication.
* Commitment to personal growth and development.
* Accountability for your work.

Location:
We are based at Edinburgh BioQuarter, which acts as a hub for Scottish Life Science with close links to the University and the Royal Infirmary.

Employer Value Proposition:
RoslinCT is seeking the best, brightest, and most passionate cell and gene therapy talent with a diverse range of skillsets, experience, and perspectives. We offer industry-leading annual leave allowances, career development opportunities and employee benefits, as well as working groups and social activities, and are dedicated to developing the next generation of experts and future leaders of our company. If you want to utilise your skills and talent in a state-of-the art company that truly changes lives, you belong at RoslinCT.