MAIN PURPOSE OF JOB
We are seeking an ambitious, highly motivated and experienced cell line development (CLD) Principal Scientist with a desire to continue to work ‘hands-on’ whilst leading and managing our ‘CMC CLD’ team activities. The individual will be accountable for the development of fully traceable, regulatory compliant clonal stable cell lines and cell pools used to manufacture novel exosome therapeutics. The scope of accountabilities spans the development of optimised vectors and host cell lines through to establishment of an industry leading exosome CLD platform - transfection, recovery, pool screening, monoclonal cell line derivation through to establishment of ‘pre-master’ clonal cell lines suitable for the manufacture of GMP MCB/WCB’s. The team will also undertake some aspects of CLD delivering research cell lines supporting early non-clinical development. The individual will oversee and manage production and manufacture of MCB/WCB’s by contract manufacturing organisations and together with Evox Quality direct the release and characterisation testing of MCB/WCB’s, including testing for adventitious virus testing to ensure compliance with regulatory standards.
We are looking for an individual who will thrive in a start-up environment, be able to lead and motivate, be able to innovate and relish the sense of accomplishment each day brings in our exciting company.
This position is based at Evox Therapeutics facility at the Oxford Science Park, Oxford, UK and reports to the Vice President, Process Development.
Lead and grow a team of cell line development scientists as well as working ‘hands-on’ to deliver CLD and platform development activities.
Develop and establish traceable and regulatory compliant optimised expression constructs the production of engineered manufacturing mammalian cell lines.
Develop and establish an industry leading Cell Line Development capability for the production of engineered exosomes therapeutics (transient and stable transfections, pool and monoclonal clone generation, pre-master cell stock banks, in-vitro cell age stability studies, genetic characterisation).
Develop and establish novel mammalian ‘host’ cell lines with attributes suitable for the production of engineered exosomes loaded with a wide range of therapeutic cargo’s.
Deliver cell line history and CLD documentation and reports ensuring appropriate quality of documentation, cell line segregation and materials traceability to support inclusion of data and information in regulatory filings.
Deliver research cell lines suitable to support early non-clinical development.
Work collaboratively with Research, Process Development and Quality to develop and establish new techniques and recommend alternative approaches and potential solutions to cell line issues.
Ensure a healthy and safe working environment and compliance to GMO/ACDP requirements.
Education and Qualifications:
PhD or BSc/MSc in Cell Biology, Molecular Biology, Biochemistry, Biotechnology, Food Science, Biological or a related field.
A highly motivated ambitious scientist with:
Ability to work independently and lead others.
Good conceptual, analytical thinking, problem solving, and organisational skills.
Ability to work in a high paced team environment, meet deadlines, and prioritise work from multiple projects.
Strong interpersonal and communication skills with demonstrated ability to work within a team environment.
Ability to balance multiple priorities and projects at the same time and be able to change priorities as needed by the business.
Experience & knowledge
At least 5+ years direct industrial laboratory experience in biologics and/or cell/viral product cell line development post PhD or 8+ years direct industrial laboratory experience as above post BSc/MSc.
Experience in the development, optimisation and establishment of industrial expression vectors and derivation of mammalian cell line development platforms complaint with regulatory expectations.
Knowledge and experience of general cell culture techniques, including transfection, selection, cloning, small scale production models and product expression.
Background in cell and molecular biology, with experience in host cell engineering, cell culture process development, vector development, and/or development of novel analytical methods to aid in cell line generation.
Familiarity with instruments commonly used in a cell line generation laboratory such as ViCell, Nutrient analysers, single cell derivation platforms, cell imagers. Use of automated systems, such as ambr15 microbioreactor system would be a plus.
Understanding of the regulatory requirements on the quality of biotechnological/biological products and derivation and characterisation of cell substrates used for production of biotechnological/biological products.
Leadership experience, ideally growing, leading, developing a cell line development team.
KEY BEHAVIOURAL ATTRIBUTES – ALL STAFF
People with Purpose – We are innovative and creative in the way we work and deliver. We treat each other with respect and dignity and work collaboratively to learn from each other’s strengths.
Driven to Deliver – We strive to deliver our objectives, and then look for our next challenge. We recognise our achievements and celebrate our successes.
Agile and Accountable – We respond to challenges impacting our progress and find creative and innovative solutions to overcome obstacles. We are brave and not afraid to change our approach to achieve a positive outcome in optimum time.
Candid and Constructive – We communicate with honesty and transparency throughout the team. We value giving and receiving constructive feedback to each other and our partners.