Job Description

Labelling & Packaging Operator - 6 Month Fixed Term Contract

Location: Edinburgh BioQuarter, Little France

Who are we?

We are RoslinCT, a world-leading cell and gene therapy contract development and manufacturing organisation creating cutting-edge therapies that change people\xe2\x80\x99s lives.

Collaborative, dedicated and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilising ground-breaking science.

Find out more about what we do !

Why join us?

• The opportunity to join a rapidly expanding company which is changing lives, giving you the skills and experience to develop your career.
• A generous salary package \xe2\x80\x93 we reward our people at the level they deserve.
• 31 days of annual leave, plus 4 public holidays which increases with tenure.
• A competitive company pension scheme to help you save for the future.
• Group Life Cover \xe2\x80\x93 you are automatically covered for three times your basic salary to give you and your family peace of mind.
• Private healthcare and access to mental health/wellbeing support as your health and wellbeing means a lot to us.
• Flexible benefits such as retail discounts and access to the Cycle2Work scheme.

Your dream role

• An exciting opportunity to join our high performing Manufacturing division as a Labelling & Packaging Operator.
• Please note - this is a 6-month Fixed Term Contract.
• You will report to and collaborate with the Labelling & Packaging Lead within the Operational Quality Improvement Team (OQIT).
• Assist in the design, construction, and start-up of our new Labelling and Packaging area which is needed to support the approval of a new commercial product.
• Consolidate all labelling and packaging operations into a single new secure unit. It is anticipated that this team will grow as manufacturing output ramps up to supply commercial demand.
• Print labels and carry out quality checks on all cleanroom assembled products.

• Contribute to the continual improvement of the labelling process.
• Be involved in setting standards for consistency of use, quality and customer focus for labelling and packaging.
• Partner with the RoslinCT Facilities team to collate and provide technical information from Manufacturing and Quality colleagues to complete the design of the new Labelling and Packaging area and associated equipment.
• Formulate detailed layouts micro-flows and operating processes assuring compliance with regulatory requirements.
• Work closely with Manufacturing and Quality Assurance to manage label generation for a wide range of manufacturing activities through preparation, pre-campaign briefing, execution, and batch record review.
• Ensure batches are manufactured correctly and released on time according to the manufacturing master production schedule and customer expectation.
• Work closely with Project Management and Supply Chain to provide correctly configured packaging and product information for shipping.
• Contribute to training to support personnel as required.
• Source and develop new packaging innovations to improve standards and quality.
• Work closely with clients to import/control artwork and client specific packaging/leaflet configurations.

About you

• This is the ideal position for someone with prior experience of pharmaceutical labelling and packaging.
• Previous experience of commercial GMP manufacturing, labelling, and packaging experience would be ideal for this position.
• Experience of commercial GMP cell and gene therapy, mammalian cell culture, sterile manufacturing and/or commercial manufacturing.
• Excellent working knowledge of commercial GMP regulations (UK, European, and US) particularly in respect of ATMPs, aseptic processing, contamination control, documentation, and record management
• A detailed understanding of the expectations associated with ATMP commercial manufacture.
• You will have a good understanding and working knowledge of PICS and ISO regulations.
• Excellent communication and interpersonal skills, with the ability to build strong working relationships internally and externally.
• Competent in the use of Microsoft Office products such as Excel and Outlook.
• Exceptional organisational and planning skills with the ability to multi-task in a fast-paced environment.
• Excellent attention to detail with a real desire to continually develop and improve our processes.

Qualifications

• A BSc in a Life Science subject or other equivalent experience.

Next Steps

If this sounds like you, then please hit \xe2\x80\x98Apply\xe2\x80\x99 now! We will ask you to upload your CV and complete a short application form detailing why you are interested and why we should hire you!

We care deeply about being inclusive and therefore welcome applications for employment from all sections of society.

RoslinCT