Process Development Manager

Based at the Edinburgh BioQuarter, RoslinCT is a leading Contract Manufacturing and Development organisation within the cellular therapies/ATMPs field, performing cutting edge investigational medicinal product manufacture for clinical trials across Europe and the US.

The Company is now embarking on an exciting period of planned growth, and we are recruiting for some key operational roles to help support and lead that growth into the future, including this one.

We are searching for an experienced, dynamic Process Development Manager to join our expanding team – this key hire will have responsibility for a team of development scientists and technicians and will oversee GMP process development activities within the company.

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:

The Process Development Manager will report directly to the Chief Operating Officer and will be highly experienced in GMP process development with a proven track record in cell biology, cell therapies and pluripotent stem cells. The individual will be responsible for leading and developing the process and assay development team including identification of new technologies, GMP translation, technology transfer and continuous improvement.

This role will additionally involve aspects of Facilities Management, Customer Service, Reporting and Budgeting, and HR (in order to grow the team) in addition to Cell Therapy Development. The Process Development Manager will be customer orientated and share our drive for customer service excellence alongside operational excellence.

Specific Responsibilities

• Lead scale up and process development of GMP manufacturing processes, assays, process validation and technology transfer for the delivery of new cell therapies.
• Ensure Cell Therapy Development projects are managed effectively, and project deliverables meet the agreed milestones.
• Support the GMP Manufacturing, Quality Control and Quality Assurance teams with the introduction of new client manufacturing processes and assays.
• Promote and uphold the company performance standards and operational excellence.
• Day to day management of the Development Laboratories to ensure effective and safe operation.
• Ensure excellence in customer service across all aspects of the Development department, including representing RoslinCT at conferences and hosting customers and regulators.
• Ensure project spending is monitored and within agreed budget.
• Recruit innovative scientists and professionals to grow the team, in addition to devising training plans and carrying out regular performance reviews.

Qualifications Required:

The post holder will have;
• A PhD in regenerative medicine/stem cell biology or equivalent qualification and experience.
• A strong relevant technical background and experience in process development.

Skills/Experience Required:

The ideal candidate will also have:
• Extensive experience and a proven track record in a senior process development role within a GMP environment and a clear understanding of cell and gene therapy
CMC.
• An excellent scientific knowledge and track record in cell biology, cell therapies and pluripotent stem cells is essential.
• Excellent leadership with the management skills and confidence to inspire others to achieve. Able to inspire and engage teams and individuals to deliver.
• A background or awareness of analytical methods for cell therapy testing is desirable.
• Excellent report writing skills with the ability to simplify and clearly present complex information. Excellent administration and office management skills.
• Sound and demonstrable knowledge of process safety management and leadership.
• Strong interpersonal skills with experience of managing external customers. Customer orientated with a real commitment to deliver results and achieve goals.
• Excellent customer service skills and the ability to naturally engage with clients in a friendly yet professional manner.
• Creates a positive environment.
• Well-developed interpersonal and communication skills, proven capability to manage and influence and maintain effective relationships with internal and external
stakeholders at all levels.
• Solid organisational and planning skills with the ability to plan ahead whilst delivering results to deadline.
• A strong team player, with consideration for the team keen to learn and share knowledge with the whole team.

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