Location: Cork, hybrid
Department: BioTherapeutics Development & Supply API
Term: 12 months Contract
Salary: €50-70k (dependent on experience)
This role will be a technical transfer role.
Your new company
There are 14 members of the team working in this area across multiple manufacturing suites, will support transfer of products at various stages of clinical development to a GMP site.
Within the department, there are 55 individuals focusing on various aspects of the business including Tech transfer, process development, life cycle management, new technologies and data sciences.
Your new role
Here at Hays, we have an exciting opportunity for a Technical Scientist to join our Multinational pharma Client on their growing BioTherapeutics Development & Supply team.
The Technical Scientist will support development projects and manufacturing operations and be responsible for leading or supporting Process Development, Technical Transfer, Process Validation, Manufacturing investigations, Life Cycle Management and Health Authority Inspections
Key duties are:
Lead/support, review and authoring of documentation prior to batch manufacture. This would be leading/supporting/ participating in meetings with cross functionals departments both within Cork and with development teams in the US.
Your typical day may include:
What you'll need to succeed
- Supporting early and late phase Technical Transfer activities through generation of protocols/reports, technical writing, execution of laboratory scale studies and participation in manufacturing operations and NPI initiatives.
- Supporting “process fit to plant” during early and late stages of development to provide guidance to both development and manufacturing teams.
- Supporting “man in plant” by providing support during manufacturing campaigns for new products or during process validation campaigns.
- Providing expertise to development teams on manufacturing facility design and capabilities, scale-up considerations and GMP operations.
- Partnering with Project Teams to provide input, review and approval support for BLA submissions.
- Interpreting project plans and timelines for CMC projects, and schedule work and experiments to meet these goals.
- Assisting in manufacturing investigations as required, in particular event, deviations and CAPAs, to help meet product release specifications and timelines.
- Executing experimental plans and protocols to support product life-cycle improvements, process validation requirements, technical transfer projects and development activities as required.
What you need to do now
- Bachelor's degree in Biology, Pharmacy or related scientific field is required, advanced degree is preferred.
- Work experience within a regulated biologics or pharma industry.
- Biological process development or commercial manufacturing experience, either cell culture and/or purification.
- Excellent collaboration & communication skills, both written and oral.
- Capable of planning and executing experiments or projects steps with some supervision.
- Ability to work well in a team environment, strong collaboration skills and flexibility.
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career. #1101577