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Johnson & Johnson
IRL - Associate Scientist/Analyst - Senior
Job is closed
Posted
Apr 7, 2022
Job ID:
JJJP00010516
Location
Cork, County Cork
Hours/week
39 hrs/week
Timeline
1 year
Payrate range
Unknown
Application Deadline: Apr 25, 2022 12:00 AM
Position Title: BTDS-AD Senior Associate Scientist-Stability Lead.
Department: BTDS-AD
Report to: Team Lead / Manager, Bioassay, Bioassay and Early Development Stability Sciences
Location: Cork
Travel: 5-10%
Global Compensation Framework Band Number: 25
Company Summary: Janssen Sciences Ireland UC is a member of the Johnson & Johnson Group of companies. BioTherapeutics Development Analytical Development Cork (BioTD-AD Cork) is a department responsible for Tox release testing, clinical release and stability testing for drug substance and drug product and stability management of the large molecule (therapeutic proteins) portfolio. In addition to clinical release & stability activities BioTD-AD Cork is responsible for analytical support for large molecules through troubleshooting, investigations, manufacturing support and analytical method transfer.
Position Summary:
Reporting to the Team Lead/ Manager, Bioassay and Early development Stability Sciences, BTDS-AD Cork, the successful candidates primary focus will be the collating, trending and reporting of release and stability data, across a range of analytical techniques, in support of regulatory filings. This individual will act as single point and subject matter expert for all release and stability related issues for assigned products. Given the diversifying Janseen clinical portfolio this may include a diverse class of molecules/entities including monoclonal antibodies, bis-specfic antibodies and antibody drug conjugates.
Main duties and responsibilities:
· Project Management of Stability Studies
· Authoring, reviewing and approving of stability protocols and procedures
· Trending of stability data
· Communication of project information, goals and objectives
· Participation in global analytical project teams
· Provision of technical expertise in support of analytical testing of biologicals in support of
· Analytical technology transfer, including co-validation/qualification.
· Troubleshooting and investigations.
Key Skills and Competencies required:
? Expertise in any analytical methodologies pertaining to release and stability testing of biologics (e.g. qPCR, ELISA, cell-based assays, cIEF, cSDS, HPLC).
? Practical analytical laboratory experience in a GLP/GMP environment is advantageous.
? Analytical Technology Transfer (equipment procurement and qualification, method qualification/validation).
? Strong problem-solving skills.
? Very strong communication skills (verbal, written & presentation).
? Project management.
? Familiar with applicable cGMP and other business compliance regulations.
? Customer focus and results and performance driven.
? Sense of Urgency.
? Ability to work well within team structures and provide leadership.
Education and Experience:
? A minimum of a Master?s or PhD degree, Virology, Immunology, Genetics, Biochemistry or a related scientific field is required.
? 5+ years of experience in academia, biotechnology, or pharma industry with a primary focus on understanding AAV biology.
? Knowledge of computer programs such as MS Word, Excel and Minitab.
? Good understanding of quality and attention to detail.
Department: BTDS-AD
Report to: Team Lead / Manager, Bioassay, Bioassay and Early Development Stability Sciences
Location: Cork
Travel: 5-10%
Global Compensation Framework Band Number: 25
Company Summary: Janssen Sciences Ireland UC is a member of the Johnson & Johnson Group of companies. BioTherapeutics Development Analytical Development Cork (BioTD-AD Cork) is a department responsible for Tox release testing, clinical release and stability testing for drug substance and drug product and stability management of the large molecule (therapeutic proteins) portfolio. In addition to clinical release & stability activities BioTD-AD Cork is responsible for analytical support for large molecules through troubleshooting, investigations, manufacturing support and analytical method transfer.
Position Summary:
Reporting to the Team Lead/ Manager, Bioassay and Early development Stability Sciences, BTDS-AD Cork, the successful candidates primary focus will be the collating, trending and reporting of release and stability data, across a range of analytical techniques, in support of regulatory filings. This individual will act as single point and subject matter expert for all release and stability related issues for assigned products. Given the diversifying Janseen clinical portfolio this may include a diverse class of molecules/entities including monoclonal antibodies, bis-specfic antibodies and antibody drug conjugates.
Main duties and responsibilities:
· Project Management of Stability Studies
· Authoring, reviewing and approving of stability protocols and procedures
· Trending of stability data
· Communication of project information, goals and objectives
· Participation in global analytical project teams
· Provision of technical expertise in support of analytical testing of biologicals in support of
· Analytical technology transfer, including co-validation/qualification.
· Troubleshooting and investigations.
Key Skills and Competencies required:
? Expertise in any analytical methodologies pertaining to release and stability testing of biologics (e.g. qPCR, ELISA, cell-based assays, cIEF, cSDS, HPLC).
? Practical analytical laboratory experience in a GLP/GMP environment is advantageous.
? Analytical Technology Transfer (equipment procurement and qualification, method qualification/validation).
? Strong problem-solving skills.
? Very strong communication skills (verbal, written & presentation).
? Project management.
? Familiar with applicable cGMP and other business compliance regulations.
? Customer focus and results and performance driven.
? Sense of Urgency.
? Ability to work well within team structures and provide leadership.
Education and Experience:
? A minimum of a Master?s or PhD degree, Virology, Immunology, Genetics, Biochemistry or a related scientific field is required.
? 5+ years of experience in academia, biotechnology, or pharma industry with a primary focus on understanding AAV biology.
? Knowledge of computer programs such as MS Word, Excel and Minitab.
? Good understanding of quality and attention to detail.
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