9 maanden geleden
Over the past year VOLT have partnered with one of the top gene therapy companies in the world, who have real focus on the development and commercialization of unique gene therapies to change lives. Most recently, they have raise over $100 million dollars funding due to data from their two ongoing clinical trials. My client are looking to make a real difference to the lives of patients suffering with genetic diseases by providing directed gene therapy as a life long and potentially curative treatment.
Role and responsibilities
Playing a vital role in the management, evaluation and development of the manufacturing department.
Lead the production project planning with cross functional teams to ensure completion. Giving you freedom to manage the maintenance schedule and production schedule.
Acting as the SME within the production site, leading team of technicians, manufacturing operators, and senior production scientist's to help deliver clinical batches. Responsible for the planning and delegation of technical tasks to DSP/USP team members during batch manufacture. Managing technology transfer of new processes into the facility.
In this role you will be made the primary point of contact within the GMP manufacturing facility, providing guidance on activities in the facility including waste /material transfer, qualification activities, equipment maintenance, equipment transfer etc.
You will be tasked on the managing the technical operations in the cleanroom for practical delivery of engineering, non-clinical and clinical batches.
Play a vital role with senior members of the company where you will be working closely with cross functional teams such QC, QA, Supply chain and Technical guaranteeing all are working towards the same goals such as successful regulatory inspections.
Educated to degree level or equivalent in a biological or engineering science.
Experience in Cell or Gene Therapy, Monoclonal Antibodies, Virus based biologics.
Minimum of 5-7 year's experience working in a GMP environment with at least 3 year's experience in a leadership role.
Minimum of 4 years hands-on experience executing Downstream or Upstream manufacturing processes.
Experienced in generating and reviewing GMP documentation and safety risk assessments.
A good working knowledge of GMP, cleanrooms, aseptic technique and hygiene requirements for GMP
If you are a self-motivated individual with a proven track record in project management looking to join a company who are achieving a high standard of work, please do reach out below!
or 01737 761 697