Development Manager - Edinburgh, United Kingdom - RoslinCT

Description

Development Manager

Location: Edinburgh

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 seeking a highly qualified and experienced DevelopmentManager to lead our dynamic Process and Analytical Development team who are responsible for advancing cell and gene therapy development for our partners.
• You will play a crucial role in driving scientific and technical excellence in process and assay development, ensuring efficient and compliant manufacturing processes, and fostering a culture of innovation.
• Set the vision and provide strategic leadership and mentoring for the Development team, promoting a collaborative and high-performance culture and team.
• Lead the effective delivery of client projects for cell therapy process development.
• Partner with the Innovation team, providing leadership and guidance to innovation projects and new service capabilities, enabling their transition to new cross-functional service capabilities.
• Demonstrate and strive to continually develop significant experience in state-of-the-art cell processing, selection, engineering, and expansion platforms, with relevant analytical methods and instruments used for cell and gene therapy manufacturing.
• Demonstrate and share knowledge in relation to relevant cGMP and ICH guidelines.
• Support the Commercial team with client opportunities, meeting clients, presenting at external events, building collaborative project proposals, and providing ongoing effective communication.
• Lead the definition of the overall Process Science strategy for client engagement, Process and Analytical Development and Technology Transfer execution.
• Oversee the development and optimization of robust and scalable cell and gene therapy manufacturing processes, with a focus on pluripotent stem cells.
• Review manufacturing processes and implement process improvements to enhance cell product safety, efficacy, and to reduce costs of goods.
• Lead business case proposals to build and manage a process and analytical development equipment/instrument portfolio that supports RoslinCT's partnership commitments and goals.
• Take responsibility for the Development department facilities, equipment, and infrastructure to ensure its suitability and ongoing availability, liaising with Health and Safety team as required to ensure ongoing safety requirements are met.
• Collaborate closely with departments across RoslinCT, especially QA, QC and MSAT to enhance processes, guaranteeing efficiency, scalability, and compliance with quality standards.
• Ensuring that all Development department plans and activities are cross-functionally communicated and aligned and delivered to key targets, on time and in a cost-effective manner.
• Keep abreast of the latest developments in automation technologies within the industry and incorporate cutting-edge solutions into the development workflow.
• Be responsible for Development Department budget, including people, infrastructure, and third-party costs.
• Responsible for resource projections and demand plans for the department.

About you

• You will have extensive experience in cell and gene therapy process development.
• Ideally, you will have experience of working in a CDMO.
• Proven leadership experience, demonstrating the ability to lead and develop high-performing teams.
• A deep understanding of cell therapy cGMP requirements, ICH guidelines, and manufacturing operations.
• Familiarity with cell product manufacturing unit operations, including, but not limited to apheresis processing, target cell selection, cell differentiation or activation, cell engineering using viral and/or non-viral vectors, cargo delivery methods (e.g., electroporation), cell expansion, harvest, and formulation for cryopreservation.
• Knowledge of analytical development including flow cytometry and cell-based assays.
• Hands-on experience with common and/or emerging technology platforms for cell processing and analytics, with an understanding of each platform's strengths and limitations.
• Strong expertise in CMC, and an awareness of regulatory requirements for cell and gene therapies.
• Prior experience with process characterisation, DoE, QbD, and demonstrated abilities in risk analysis.
• In-depth knowledge of current Good Manufacturing Practice (cGMP) regulations.
• Experience in the application of closed and automated systems, including bioreactors.
• You will have excellent written and verbal communication skills with the ability to partner with all levels of RoslinCT.
• Excellent organisational skills with the ability to multi-task in a fast-paced and dynamic environment.
• Experience and knowledge of pluripotent stem cell processing and analysis.

Qualifications

• BSc or PhD level education in a relevant scientific discipline.

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 . We're here to assist and make things as smooth as possible for you.