Position Title: BTDS AD - Scientist
Department: Discovery, Product Development and Supply; BioTherapeutics Development & Supply Analytical Development – (DPDS, BTDS-AD)
Report to: Team Lead, Separation Sciences
Travel : 5-10%
Global Compensation Framework Band Number: 26
Company Summary: Janssen Sciences Ireland UC is a pioneer in the use of mammalian cells to manufacture monoclonal antibodies. €537 million was invested in Cork to build a manufacturing facility to produce the next generation of fully humanized antibodies. The Cork facility was the largest green field start up ever undertaken by J&J.
BioTherapeutics, Development and Supply (BTDS) Analytical Development (AD) group is a department of Discovery, Product Development and Supply, Janssen R&D organization. The department is responsible for Tox release testing, Clinical release and stability testing for drug substance and drug product, chamber and sample handling and stability management. The AD department in Cork, Ireland, is responsible for analytical support for large molecules.
Reporting to the Separation Sciences Technology Team Lead (HPLC, cIEF or cSDS), the person will lead various projects, focused on Separations based assays and associated analytical techniques, while being responsible for testing and resolution of product related issues in support of the Separation Sciences team. They will partner with other AD teams and departments to ensure that all BTDS AD activities are completed in an efficient manner.
Main duties and responsibilities:
- Co-ordination and execution of routine release and stability testing for Separations Methods for pre-clinical and clinical product development.
- Lead Analytical Technology Transfer activities.
- Testing to support assay validation/qualification and other studies.
- Review, interpretation, and trending of Laboratory generated data.
- Review operation and maintenance of laboratory equipment.
- Completion of documentation in adherence to GMP.
- Leads Technical discussions with AD Method development group.
- Promotes a continuous improvement culture while leading and generating continuous improvement projects.
- Initiates Quality Issues, leads in the investigation, perform investigation analysis and provide necessary information to enable implementation of effective CAPA.
- Perform Data Trending to support investigations, demonstrate method capability and product profile.
- Write SOP’s, protocols, work instructions and training modules.
- Ensures trainings are completed on time and all tasks are performed only after completion of trainings on current effective procedures.
- Perform laboratory support activities as per training and perform tasks related to audit readiness.
- Is an active member of team and aids and leads with other group activities as required and communicates relevant issues to the BTDS AD Team Leader and Manager.
- Anticipates and plans for future requirements in Separations Team.
- Deals with non-conformances/ deviations and in an accurate and timely manner.
- Maintains and develops knowledge of analytical technology as well as cGMP Standards.
- As required lead process analytical support testing for early development support in collaboration with other BTDS functions.
- Deputize as appropriate for Team leads.
- Other duties as assigned by team leads.