Bioanalysis Science Manager

Posted: 04/10/2021 Location: BioCity Nottingham Start date: December 2021

The Role: Leading R&D Bioanalysis Operations to proactively support biopharmaceutical production strain and process development at Phenotypeca for research, grant, IP and commercial projects.  The role involves providing protein characterisation and bioanalysis services to inform upstream process development for optimal strain selection, downstream process development and final formulation.  Building in-house capabilities and partnering with external service providers will be required.  The position is primarily based at BioCity Nottingham UK, with some operations at the University of Nottingham.  UK and international travel will be required on occasion, e.g. customer/partner visits and conferences.

 

Key responsibilities:

  1. Provide protein chemistry and bioanalytical services to deliver on Phenotypeca’s mission of “producing world-leading yeast systems for the industrial-scale manufacture of recombinant proteins, to make medical treatments more affordable to all who need them, not just those that live in the wealthiest nations”.
  2. To work effectively in a multidisciplinary team, directly supporting strain development, fermentation, protein purification and formulation activities to meet company targets and timelines.
  3. To lead and manage R&D Bioanalysis Operations, liaising with:
  4. Service providers and partners for external analysis.
  5. Equipment providers and suppliers to build in-house capabilities.
  6. Customers and partners for successful technology transfer.
  7. To establish industry recognised analytics for recombinant protein products to monitor yield and quality criteria during R&D scale biopharmaceutical process development and final product formulation.
  8. Support high-throughput (HTP) analytics for rapid yield and/or product quality measurements in crude samples, e.g. for HTP strain selection (including for automated systems) and fermentation.
  9. Support R&D protein purification activities for optimal downstream process development enabling efficient scale-up for low-cost cGMP manufacturing. 
  10. Provide a final product analytical packages ensuring that production strains and downstream process descriptions are fit for cGMP manufacturing by partners/customers.
  11. Maintain a safe working environment at all times in compliance with Phenotypeca’s procedures and guidelines. Prepare and maintain EH&S documentation.
  12. Contribute to effective operation and management of Phenotypeca systems such as Electronic Lab Notebooks, Timesheets, SharePoint and Teams,  ensuring high-quality documentation and record-keeping for our customers and stakeholders.
  13. Support routine ordering and maintenance of equipment, consumables and spares and the creation of standard procedures and protocols for the continuous improvement of workflow efficiency.

 

The ideal candidate-

Must have:

  • A strong motivation to play an integral part developing the next generation of yeast bioprocess technology for industrial biologics manufacturing.
  • A degree in a life-science subject plus relevant post-graduate qualifications and/or a strong track record in the bioprocess industry.
  • Hands on protein chemistry and bioanalytical experience with evidence of working collaboratively with established experts in the field.
  • A full appreciation of bioprocess development and cGMP manufacturing.
  • Ability to set up and/or perform bioanalytical methods for protein product yield and quality evaluation, e.g. HPLC, MS, PAGE/capillary electrophoresis, ELISA, post-translational modification determination, SPR, functional assays, host cell protein clearance, pyrogens, process-related impurities/leachates.
  • Experience in protein product formulation and final product stability testing. 
  • Experience using AKTA equipment and other process development equipment.
  • Ability to effectively manage internal and external resources.
  • Experience working in a multidisciplinary team developing cGMP manufacturing processes.
  • Effective time-management skills and the ability to work to deadlines.

 

Would be good to have: 

  • A post-graduate degree or qualification.
  • Experience with final formulation of protein therapeutics for human use.
  • An appreciation of regulatory issues affecting bioprocess development.
  • Experience working in a GLP environment and/or supporting a cGMP biologics manufacturing process.
  • An appreciation of LEAN methodology.
  • Skilled with design-of-experiments software.
  • Experience of writing lab SOPs, COSHH risk assessment and ensuring safe working practices.
  • Laboratory management, team leadership and/or project management skills.
  • Familiarity working in agile teams in a matrix management system.
  • Experience using laboratory automation and robotics systems.
  • IT literate with experience in big data handling.
  • Artificial intelligence and/or machine learning experience. 
  • Experience of Python or other programming in equipment digital interface design

 

Personality:

  • Project and goal orientated.
  • Customer focussed.
  • A proactive problem-solver.
  • Professional team worker.

 

Will Report to:

You will report to the Research Director and/or Operations Director. 

We offer a competitive salary based on your experience, skills, and qualifications; 24 days holiday plus bank holidays (England); additional benefits could include performance bonus and possible share options after 12 months.

This role will be based in BioCity Nottingham, UK.

Normal Working Hours: 7.5hrs per day between 8 am and 6 pm Monday to Friday*.

The Company: Phenotypeca are building the ‘go-to’ platform for the development of baker’s yeast strains for industrial-scale manufacture of vaccines, therapeutics, and other recombinant proteins. Our mission is to make these treatments more affordable (lower COGS) to all who need them, not just those that live in the wealthiest nations.

These markets had over $200billion in revenue globally in 2020 and we know there is a massive untapped demand for a cheaper alternative to the current available platforms, as our team were involved in creating and filing the patents for the first-generation baker’s yeast platforms. We provide unique, customised strains and intellectual property for their specific strains, to our life science customers whilst constantly increasing the speed and value of our platform using automation and robotics, Artificial Intelligence and robotics, and our extensive know-how (filing appropriate patents). 

Applications: If you are collaborative and commercial, are driven by high performance, expect scientific excellence, have strong business ethics, but most of all want a work environment where you can be happy and thrive, please send your CV and a covering letter to careers@phenotypeca.com  explaining why you think you are suitable for the role.

Phenotypeca is an Equal Opportunities Employer.

No agencies, please.

*- may be required to work outside of these hours as work requires.