Senior Technical Scientist - Technical Transfer
We are currently recruiting for an exciting opportunity with a pharmaceutical organization based in Cork. This is an excellent position for anyone looking to join a leading multinational company that excels in its field.
Duties:
* Support early and late phase technical transfer activities by generating protocols/reports, performing technical writing, executing laboratory-scale studies, and participating in manufacturing operations and NPI initiatives.
* Support early and late phase product development activities by generating protocols/reports, executing laboratory-scale studies, and participating in Lean Early Development initiatives as required.
* Support 'process fit to plant' during early and late stages of development to provide guidance to both development and manufacturing teams.
* Support 'man in plant' by providing support during manufacturing campaigns for new products or during process validation campaigns.
* Provide expertise to development teams on manufacturing facility design and capabilities, scale-up considerations, and GMP operations.
* Participate in cross-functional project teams.
* Interpret project plans and timelines for CMC projects and schedule work and experiments to meet these goals.
* Assist in manufacturing investigations as required, particularly events, deviations, and CAPAs, to help meet product release specifications and timelines.
* Execute experimental plans and protocols to support product life-cycle improvements, process validation requirements, technical transfer projects, and development activities as required.
* Foster a culture of Lean and Continuous improvement within the department and with internal and external partners.
Education & Experience:
* Technical transfer experience is highly advantageous.
* A minimum of a Bachelor's degree in Biology, Pharmacy, or a related scientific field is required; an advanced degree is preferred.
* Experience within a regulated biologics or pharma industry is essential.
* Biological process development or commercial manufacturing experience, either cell culture and/or purification, is desirable.