MSAT Lead

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Job Details

Location
Darlington, England
Salary
£42,000 - £54,000 per annum- dependent on experience
Employment
Full-time - Permanent
Team
Science and Engineering
Deadline
04 Dec 2022 - 23:45
Reference
CPI-5785-22
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About CPI

CPI helps make great ideas and inventions a reality. We’re a team of intelligent people using advances in science and technology to solve the biggest global challenges in healthcare and sustainability.

Through our incredible people and innovation infrastructure, we collaborate with our partners in industry, academia, government, and the investment community to accelerate the development and commercialisation of innovative products.

From health technologies and pharmaceuticals to sustainable food and materials innovations, we turn the entrepreneurial spirit and radical thinking of our people and partners into incredible impact that makes our world a better place.

Why this role is important for CPI’s work

CPI is recruiting for an experienced MSAT Lead to join the growing Biologics Technical team based in Darlington. The team is responsible for the delivery of all R&D work across the Biologics business unit, including consultancy and technology transfer. Supporting customers and collaborators with developing their own products and processes, to support investment and commercialisation. 

CPI Biologics Technical Group works on a varied portfolio of projects, working with a wide range of products including monoclonal antibodies, viral vectors, recombinant proteins, microbial therapeutics, and synthetically produced nucleic acids using conventional and advanced manufacturing approaches. The work of the group is diverse, examples including: 

RNA technology is a novel and potentially revolutionary emerging modality for both vaccinations and for the treatment of the previously undruggable. In the role of MSAT Lead, you will have the opportunity to work alongside R&D to develop GMP-ready RNA processes and lead the transfer of these into CPI’s Centre of Excellence. With RNA manufacturing technology still developing, you will help define best practices for RNA manufacturing, working with customers and collaborators to assist in the manufacture of their novel and innovative products. Managing a small MSAT team you will report to the Technology Lead, leading on the transfer of R&D processes internally and externally into GMP, working alongside customers and the various internal functions to support the establishment of GMP processes. 

Click here for more information on the RNA Centre of Excellence

Key activities in the role of MSAT role will include but are not limited to:

Technical point of contact for customers for technology transfer into GMP manufacture. 

To work closely with GMP Operations and QA as tech transfer lead to support the transfer of new processes and products into CPI’s GMP manufacturing facilities.

To provide specialist technical training to members of the GMP Operations team where appropriate.

To use technical knowledge to contribute to process deviation investigations, impact assessments, and reports.

To support GMP Operations and Bioengineering with fit assessments/​gap analyses of equipment, facilities and processes. 

To provide technical input where required to other functions including QA, QC, R&D, Bioengineering and procurement. 

Please download the job description for full responsibilities.

The person we are seeking

You will be educated to a minimum of HNC or Foundation Degree level (or equivalent) in a relevant Scientific/​Engineering discipline and have significant industrial experience. Ideally, you will be educated to Degree/​Masters/​PhD level (or equivalent) in a Scientific/​Engineering discipline and hold industrial experience in a relevant field.

It is essential you have the following: 

An understanding of cGMP, FDA and EMA guidance, ICH guidelines, and CMC content of regulatory submissions.

Demonstrable experience working in a GMP tech transfer environment or in a GMP Quality Management System.

Track record of technology transfer of processes for the production of Biologic products.

Understanding of the principles relating to GMP manufacture.

Significant, technical expertise in Biologics and Bioprocessing.

Leadership and communication skills across multidisciplinary teams.

It is desirable you have one or more of the following:

Qualification in People Management.

Project management experience.

Supervision/​management of other team members.

An active member of a professional body, engaging with peers beyond CPI.

Experience with RNA-LNPs (R&D or GMP context) is highly advantageous.

What does CPI offer you?

At CPI, we offer a wide range of benefits to our employees, this includes:

  • Up to 36 days holiday, including bank holidays – Plus a holiday purchasing scheme
  • Generous pension scheme
  • Life assurance and accident insurance schemes
  • Flexible working
  • Learning and Development Opportunities
  • Free parking

Find out more about our culture and benefits.

Additional information

CPI is an organisation based in the UK. Commencement of employment is conditional to demonstrating right to work in the UK, sponsorship may be available.

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