Oxford BioMedica is a pioneer of gene and cell therapy and our work is helping to deliver life changing treatments.
Gene and cell therapy is the treatment of disease by the delivery of therapeutic DNA into a patient’s cells, providing long term and potentially curative treatments for a wide range of diseases. With the potential to transform medicine, the sector holds significant promise with the first commercial products now launched and others rapidly approaching the market
Our recent successes are driving significant growth. As such, we are looking for a Principal MSAT Scientist to join our MSAT team.
To manage the effective performance of a major project with a tactical focus on meeting the scientific, clinical, manufacturing and business requirements of the department in line with company goals.
Provide technical and scientific support to the clinical and commercial manufacturing activities at Oxford BioMedica (OXB) and third party CMO sites including technology transfer, technical troubleshooting, complex deviation investigations, change control, and continuous improvement.
As necessary lead and perform root cause investigations using a systematic approach to resolve complex problems and lead multidisciplinary teams in developing and implementing solutions.
Partnering with other functions to ensure scale-up is robust and scientifically sound leading to consistent performance
Key responsibilities and accountabilities:
The candidate will be an influential MSAT representative within OXB working across multiple projects at different stages of the commercial product lifecycle.
Provide technical expertise to other departments and contribute to the scientific and business needs of the company.
Provide leadership and direction on MSAT activities to the various in-house and partnered project teams to ensure all project deliverables and milestones are met within agreed scope, timelines and budget
Responsible for internal documentation to ensure quality and compliance required for regulatory submissions.
Generate and review documentation supporting technology transfer and NPI. Define success criteria for technical transfer and provide expert evaluation of the technical outcomes.
Contribute to cross department activities providing expert advice and technical input where required.
Establish business relationships with external contractors and partners to ensure that department objectives are met.
Actively provide solutions to process problems and contribute to company-wide issues where required.
Maintain a high ethical standard and a commitment to producing high quality work.
Develop relationships with suppliers and service providers
Provide guidance on MSAT activities and support activities to junior members of the team.
There may be a requirement to perform additional duties as assigned.
Key skills and requirements:
Process development or GMP production experience preferably in upstream adherent/suspension cell culture and downstream (purification) processing
Experience in aseptic processing and/or fill & finish would be desirable
Proven influencing skills at all levels of the company across multiple project teams.
As a person in plant, provide technical support and training of manufacturing personnel to improve understanding of cell culture, purification and fill & finish operations across the different manufacturing sites.
Expertise in the use / application of variety of problem solving tools and quality risk assessment methodologies would be ideal.
Travel may be required in support of tech transfer activities.
Excellent written and verbal communication skills
Experience of managing multiple projects and tasks
Excellent organisational and time management skills
Ability to prioritise workloads and work under pressure
Good attention to detail
Bachelor degree, (Masters/ PhD / EngD preferred) in a life science subject or biotechnology, chemical engineering or related discipline
Strong experience in GMP manufacturing/ manufacturing science and technology/technical development/quality preferred. Experience in aseptic processing and/or fill & finish would be an advantage.
Demonstrated interpersonal skills with ability to work cross-functionally both with internal and external partners.
Excellent communication skills to gain internal company support and influence external partners, internal project teams and CMOs at all levels.
An interest in operational excellence is desirable.
Proven leadership and project management experience
A highly motivated, enthusiastic individual; with a positive attitude
Knowledge of Microsoft Office Suite, preferably with JMP® and Minitab® statistical analysis software
Experience in process automation and software solutions would also be an advantage.