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Sterile Manufacturing Training Specialist posted by RoslinCT

Full Time
EH16, Gilmerton, City of Edinburgh

Job Description

An exciting new opportunity has arisen within RoslinCT for a Sterile Manufacturing Training Specialist / Cell Therapy Manufacturing Training Supervisor​​​​​​​. RoslinCT is a leading Cell & and Gene Therapy Contract Manufacturing and Development Organisation (CDMO) based in Edinburgh currently undergoing significant growth.
The Sterile Manufacturing Training Specialist is a new role created to support growth across the business. The successful candidate will be hands-on but also integral to improving our onboarding and company-wide knowledge-based training programmes supporting the development, manufacture and testing of Cell & Gene Therapy products. We expect this role to grow in the future and play a pivotal part of developing our Training Academy.
The primary purpose of the Manufacturing Training Supervisor is to educate our staff on the theoretical and practical aspects of aseptic processing and manufacture of cell therapy products, and will report directly to the Head of Manufacturing Operations.
Expectations for this position are:
1. To co-ordinate and provide hands-on technical training (theoretical and practical) to new and existing personnel including:
a. Cell culture
b. Aseptic processing and qualifications
c. Sterile manufacturing regulations
d. Clean room behaviours
2. Develop a modularised approach to the training of new staff, reducing onboarding time whilst maintaining high quality, consistent, knowledge based learning and assessments.
3. The Manufacturing Training Supervisor will work with the operational teams to establish a network of internal and external Subject Matter Experts and trainers that champion right first time and best practice sharing. Expected to contribute to build a learning program across the organization aligned with the business strategy. The successful candidate will contribute to the learning agenda from a People, Content, Systems and Tools perspective ultimately integrating it into the Organizational and Personnel Development programs. This aspect of the role is an integral part of our plan to develop a Training Academy encompassing a training organization and culture that is both progressive and recognized as best in class within the Cell & Gene Therapy development and manufacturing arena.
4. Other aspects of the role will include oversight of documents and training packages ensuring they are harmonized and written to minimize in-operation execution errors.
Candidates for this role must also be able to demonstrate a strong commitment to our Core Values, and so should be:

• Passionate about Customer Satisfaction

• Able to support a ‘one team’ approach

• A great communicator

• Committed to personal growth and development

• Accountable for their work
Main Function:

• Hands-on trainer and responsibility for onboarding new personnel.

• Deliver cGMP training modules related to technical manufacturing operations, proper operator behaviour and maintenance of the aseptic sterile manufacturing environment.

• Coordination of additional cGMP training, interfacing with all other relevant departments, such as Quality Assurance, to ensure a wholistic training programme for staff.

• Owner of the designated training laboratories ensuring set-up and equipment closely mimics manufacturing capabilities.

• Monitor smoke studies, Process Simulation Tests and commercial runs to continuously improve existing training methodology and develop training materials.

• Collaborate in the creation of training curriculums and design an effective training plan for technical and manufacturing needs with aim of maximizing performance and reducing onboarding time for new personnel.

• Collaborate with Operational Leads to determine timelines and department training priorities.

• Conduct regular GEMBA walks and observe employees entering aseptic areas and/or performing aseptic activities in order to re-enforce correct gowning and sterile manufacturing behaviours/ techniques.

• Participate in training-related company-wide decisions and processes.

• Issue monthly training reports to drive participation, accountability and compliance standards
Qualifications Required:
The post holder will have;

• Life Science degree or equivalent qualification/experience.

• Preferably Green Belt certified with experience of implementation of Lean Six Sigma tools.
Skills/Experience Required:
The ideal candidate will also have:

• Experience of cell culture methods and techniques.

• Experience of working in an aseptic sterile manufacturing environment or supporting functions.

• Extensive knowledge in training, organizational development or related field.

• Experience of the ADDIE or similar training development model.

• Sound understanding and experience with various training methodologies, change management, continuous improvement and innovative technology relating to training.

• Excellent working knowledge of cGMP requirements in respect of aseptic processing, contamination control, documentation and record management.

• Ability to handle multiple priorities in a dynamic environment.

• Working knowledge of cGMP, PICS and ISO regulations.

• Ability to break down complex principles and concepts into teachable elements.

• Excellent communication and presentation skills.
Behaviours Required:
The ideal candidate will also demonstrate:
* Excellent oral and written communication skills; able to explain technical or complex concepts in a clear format.
* Ability to learn and share knowledge with the management team and the wider team where appropriate.
*
Excellent communication and interpersonal skills and a proven track record in maintaining effective relationships and working with a wide range of people.
*
The ability to work effectively within a small team.
*
Excellent administration and record keeping skills.
*
Excellent attention to detail with a desire to continually develop and improve our processes
* A determination to succeed, with a "can do attitude"
*
Exceptional organisational and planning skills with the ability to plan ahead whilst delivering to deadline.
* A determination to continually develop and improve standards.
* Creates a positive environment through self-awareness and social skills.
* Takes responsibility for setting high standards and looks at the bigger picture to recognise the impact of actions.
* Emotional resilience and an ability to work under pressure with good humour.
Benefits:

•Group Personal Pension Plan: 3% Employee contribution with an Employer contribution of initially 5% for the first year of joining the scheme then a 1% increase per year until a maximum of 8% is reached.

•Group Life Cover, 3X Salary

•Health4All Cash Plan where you are able to claim cash back towards dental check-ups and treatment, new glasses, contact lenses and therapy treatments such as physiotherapy and chiropody and more.

•Employee Assistance Programme

•31 days annual leave with an extra day from 3 years’ service and a further day from 5 years’ service.

•4 public holidays
Salary: Competitive
Location: Edinburgh and Lothian
Closing Date: TBC

Reference Number

212234637

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