PDMS CRS Bioassay Scientist-00000JBI
Description
Position Title: PDMS CRS Bioassay Scientist
Department: PDMS CRS
Report to: Dyan Sheehan/Peter Dowling
Location: Cork
Travel: 5-10%
Global Compensation Framework Band Number: 26
Company Summary: Janssen Biologics (formerly Centocor and a member of the Johnson & Johnson Group of companies) 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.
Global Clinical Release & Stability is a department of Pharmaceutical Development and Manufacturing Sciences – Analytical Development (PDMS-AD). 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 - as well for small molecules as for large molecules. The Clinical Release & Stability department in Cork, Ireland, is responsible for analytical support for large molecules.
Position Summary:
Reporting to a Manager in the Clinical Release and Stability Dept., the person will lead and advise on various projects, focused on biological assays and associated analytical techniques, and testing issues in support of clinical release and stability testing.
Main duties and responsibilities:
- Provision of expert bioassay technical support in CRS
- Provide technical leadership to the bioassay area personnel
- Analytical technology transfer, including Bioassay co-validation/qualification.
- Perform, design and direct bench experiments as required
- Troubleshooting and investigations.
- Drive Continuous improvement initiatives, including bioassay optimisation
- Technical coaching/training of area personnel.
- Technical liaison with Bioassay Method Development Group, external vendors and 3rd level institutions/relevant government bodies.
- Remain current with regard to cell biology, Bioassay methodologies, technology and equipment, membership of relevant professional bodies.
- Independently write SOP’s, protocols, reports and IMPD/IND regulatory filing documents.
- Supports the Manager for anticipating and planning future requirements in the area
- Contribute to area management operational and strategic initiatives.
- Presents technical analytical data clearly and concisely to customers i.e. internal and external regulatory inspections.
- Ensure compliance with applicable cGMP and other business compliance regulations.
- Participate in risk assessments, inspections, audits, etc. and implement and follow-up CAPA’s assigned.
Key Skills and Competencies required:
- Expert in cell biology/cell culture/cell based and binding Biological Assays
- Analytical Technology Transfer (equipment procurement and qualification, bioassay method qualification/validation)
- Strong problem solving skills (green belt level)
- Proficient in Bioassay data reduction, reporting and statistical analysis (biostats)
- Experimental design, including DOE, bioassay development
- Automation and 5S
- Very strong communication skills (verbal, written & presentation)
- Project management
- Lean labs
- Familiar with applicable cGMP and other business compliance regulations
- Demonstrate capabilities in strategic thinking
- Customer focus and results and performance driven
- Sense of Urgency
- Ability to work well within team structures and provide leadership.
Qualifications
Education and Experience:
- Minimum higher level qualification (M.Sc./Ph.D.) in Cell/Molecular Biology, Biochemistry (or related science subject).
- Lean six-sigma (green belt)
- Minimum of 2 Years Bioassay/Cell Culture experience is a development/technical role in Biotech Industry/Academia
- Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
Primary Location:Europe/Middle East/Africa-Ireland-Cork-Ringaskiddy
Organization: Janssen Biologics (Ireland) (8167)
Travel:Yes, 10 % of the Time
Job Function: R&D
Description
Position Title: PDMS CRS Bioassay Scientist
Department: PDMS CRS
Report to: Dyan Sheehan/Peter Dowling
Location: Cork
Travel: 5-10%
Global Compensation Framework Band Number: 26
Company Summary: Janssen Biologics (formerly Centocor and a member of the Johnson & Johnson Group of companies) 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.
Global Clinical Release & Stability is a department of Pharmaceutical Development and Manufacturing Sciences – Analytical Development (PDMS-AD). 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 - as well for small molecules as for large molecules. The Clinical Release & Stability department in Cork, Ireland, is responsible for analytical support for large molecules.
Position Summary:
Reporting to a Manager in the Clinical Release and Stability Dept., the person will lead and advise on various projects, focused on biological assays and associated analytical techniques, and testing issues in support of clinical release and stability testing.
Main duties and responsibilities:
- Provision of expert bioassay technical support in CRS
- Provide technical leadership to the bioassay area personnel
- Analytical technology transfer, including Bioassay co-validation/qualification.
- Perform, design and direct bench experiments as required
- Troubleshooting and investigations.
- Drive Continuous improvement initiatives, including bioassay optimisation
- Technical coaching/training of area personnel.
- Technical liaison with Bioassay Method Development Group, external vendors and 3rd level institutions/relevant government bodies.
- Remain current with regard to cell biology, Bioassay methodologies, technology and equipment, membership of relevant professional bodies.
- Independently write SOP’s, protocols, reports and IMPD/IND regulatory filing documents.
- Supports the Manager for anticipating and planning future requirements in the area
- Contribute to area management operational and strategic initiatives.
- Presents technical analytical data clearly and concisely to customers i.e. internal and external regulatory inspections.
- Ensure compliance with applicable cGMP and other business compliance regulations.
- Participate in risk assessments, inspections, audits, etc. and implement and follow-up CAPA’s assigned.
Key Skills and Competencies required:
- Expert in cell biology/cell culture/cell based and binding Biological Assays
- Analytical Technology Transfer (equipment procurement and qualification, bioassay method qualification/validation)
- Strong problem solving skills (green belt level)
- Proficient in Bioassay data reduction, reporting and statistical analysis (biostats)
- Experimental design, including DOE, bioassay development
- Automation and 5S
- Very strong communication skills (verbal, written & presentation)
- Project management
- Lean labs
- Familiar with applicable cGMP and other business compliance regulations
- Demonstrate capabilities in strategic thinking
- Customer focus and results and performance driven
- Sense of Urgency
- Ability to work well within team structures and provide leadership.
Qualifications
Education and Experience:
- Minimum higher level qualification (M.Sc./Ph.D.) in Cell/Molecular Biology, Biochemistry (or related science subject).
- Lean six-sigma (green belt)
- Minimum of 2 Years Bioassay/Cell Culture experience is a development/technical role in Biotech Industry/Academia
- Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
Primary Location:Europe/Middle East/Africa-Ireland-Cork-Ringaskiddy
Organization: Janssen Biologics (Ireland) (8167)
Travel:Yes, 10 % of the Time
Job Function: R&D
