Team Leader- Analytical Characterisation

**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 has an opportunity for an experienced Biopharm Analytical Scientist to lead an Analytical R&D team at CPI’s National Biologics Manufacturing Centre based in Darlington. The role is offered on a full-time basis, with flexibility around start and finish times.

With an ever-expanding portfolio of projects in delivery and in the pipeline, spanning across a breadth of expression systems, product types and customers, it is a great opportunity to be a part of, and steer the future development, of the Analytical team.

**Key responsibilities**:
We are seeking a versatile and enthusiastic analytical team leader who will contribute to, and lead, the technical delivery of projects for a range of product types (e.g. mAbs, recombinant proteins, RNA and AAVs).

This role provides an opportunity to work across a variety of analytical techniques, to include:
high performance liquid chromatography (UPLC/HPLC), mass spectrometry, mass photometry, capillary isoelectric focussing, biolayer interferometry, dynamic light scattering, differential scanning calorimetry, circular dichroism, capillary electrophoresis, ELISA, polymerase chain reaction techniques (qPCR and ddPCR), microfluidic imaging, SEC-MALS and SDS-PAGE.

You will act as technical lead on a variety of projects, where analytical work packages can include:

- Design and development of analytical methods
- Molecule characterisation
- Identify critical quality attributes and molecule heterogeneity (e.g. charge variants, amino acid and nucleic acid modifications, protein glycosylation, AAV capsid structure, genome integrity, packaging efficiency, RNA capping efficiency, PolyA tail analysis)
- Investigate stability (e.g. fragmentation, aggregation, solubility, particle formation)
- Higher order structure analysis
- Monitor residuals and impurities, to support bioprocess development (e.g. host-cell proteins, residual DNA, RNA, and endotoxins)
- Accelerated stability/forced degradation studies
- Understand degradation pathways
- Develop stability indicating assays
- Support formulation development
- Identify critical quality attributes

As a team leader, you will have the opportunity to provide training, mentoring and supervision to team members. In addition, you will work collaboratively with business development, bid proposals and technical colleagues across the upstream and downstream teams, to contribute to project development and customer engagement.

**Projects the team have recently worked on**:
The 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:

- Supporting scale of mRNA manufacturing processes with the Vaccine’s taskforce (VTF)
- Developing a manufacturing process for a vaccine-like particle vaccine product
- Development of advanced process control to accelerate drug manufacture
- Optimisation of media for in-vitro cultured meat production

**The person we are seeking**:
**It is essential that you**:

- Are educated to a minimum of HNC or Foundation Degree level (or equivalent) in a Scientific/Engineering discipline plus hold significant industrial experience at a senior level. Ideally, you will be educated to degree level in a Scientific/Engineering discipline(or equivalent) or above and hold significant relevant industrial experience.
- Have in depth and comprehensive experience, and understanding, of a range of analytical techniques for biologics characterisation, including but not limited to high performance liquid chromatography (UPLC/HPLC), mass spectrometry, mass photometry, capillary isoelectric focussing, biolayer interferometry, dynamic light scattering, differential scanning calorimetry, circular dichroism, capillary electrophoresis, ELISA, polymerase chain reaction techniques (qPCR and ddPCR), microfluidic imaging, SEC-MALS and SDS-PAGE.
- Have experience of working in multidisciplinary teams.
- Have experience of delivering projects as a technical lead.
- Strong communication skills, to present data externally to cu