Manufacturing Training Expert

RoslinCT; City of Edinburgh; On-site; GBP 100,000 - 125,000; Full time

Job summary

A leading gene therapy organization based in Edinburgh is seeking a Manufacturing Training Expert to provide advanced training within the manufacturing environment. The ideal candidate will have a Life Science degree and experience with CASGEVY™ processes. Responsibilities include delivering technical training, guiding aseptic practices, and collaborating with various teams to ensure compliance. This role offers competitive benefits and the opportunity to contribute to life-changing therapies.

Benefits

Generous salary package

31 days annual leave plus public holidays

Competitive pension scheme

Private healthcare

Qualifications

• Expert in the CASGEVY™ process and associated documentation.
• Experience in a cGMP manufacturing operation.
• Knowledge of regulatory requirements for ATMP and sterile pharmaceuticals.

Responsibilities

• Provide training and guidance in a cleanroom environment.
• Deliver technical skill training and improve manufacturing awareness.
• Work collaboratively with MSAT and QC teams.

Skills

Experience in CASGEVY™ cell culture methods

Knowledge of CGMP requirements

Ability to influence high levels of compliance

Flexibility to work under deadlines

Education

Life Science degree

Job description

Manufacturing Training Expert - Commercial

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’s 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 here!

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 – 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 – 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 new role

• We are looking for aManufacturing Training Expert to join our team!
• The purpose of this role is to provide expert, credible and interactive CASGEVY™, EM and Sterility Assurance training, guidance and coaching to the expanding Commercial Manufacturing team, pre-dominantly within the manufacturing environment (on-plant).
• You’ll be responsible for delivering a high level of technical and knowledge-based training within the cleanroom to broaden and deepen technical skill, sterile manufacturing awareness, cleanroom management and cleanroom behaviours.
• Work “hand in hand” with MSAT and QC (EM and Sterility Assurance) to guide, coach and deliver an embedded culture of correct technical practices, clean room behaviours and aseptic techniques including application of first air principles.
• Work with the Operational Quality Improvement Team (OQIT) to determine true root cause and establish corrective actions.
• Develop and deliver a training per shift focussed programme encompassing technical, clean room and aseptic practices.
• Provide process relevant training/supervision of manufacturing skills/equipment use and equipment trouble shooting within the cleanroom environment.

About you

• Experience in CASGEVY™ cell culture methods and techniques.
• Comprehensive understanding of the CASGEVY™ manufacturing process from start to finish.
• Experience in corrective/preventative action implementation/training.
• Experienced in working in an aseptic sterile manufacturing environment or supporting functions.
• Excellent working knowledge of CGMP requirements in respect of aseptic processing, contamination control, documentation and record management.
• Working knowledge of CGMP and the regulatory requirements associated with ATMP and sterile pharmaceutical manufacturing.
• Demonstrate a ‘one team’ approach by working collaboratively with colleagues across the organisation such as OQIT, MSAT, Training Academy and Manufacturing.
• Flexibility and ability to work to tight deadlines and deliver results.
• Influencer and advocate of high levels of CGMP and GDP compliance.
• Flexible approach and willingness to work above and beyond as determined by business-critical needs and ad hoc events.

Qualifications

• Life Science degree and relevant industrial experience within a cGMP manufacturing operation. Expert in the CASGEVY™ process and associated documentation.

Next Steps

If this sounds like you, then please hit ‘Apply’ 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.

At RoslinCT, we’re all about inclusivity and creating a fair, welcoming workplace. Our goal is to make sure everyone knows they’re valued and encouraged to be themselves, whether they’re our employees, customers, or partners.

We take pride in being an equal opportunity employer. We treat all applicants fairly and don’t discriminate based on any protected characteristics. So, no matter who you are, we welcome your application with open arms.

If you’ve got any specific needs or concerns regarding accessibility during the recruitment process, don’t hesitate to reach out to us at [e-mail]. We’re here to assist and make things as smoot