Associate Scientist

Johnson Johnson; Cork; Sur place; EUR 39 000 - 58 000; Plein temps

Résumé du poste

Johnson & Johnson Innovative Medicine is seeking a Separations Sciences Associate Scientist for an on-site, 12-month contract in Barnahely, Ireland. The role involves GMP-compliant analytical testing, method validation, data interpretation, and collaboration with cross-functional teams within Therapeutics Analytical Development.

You will receive training on specific assays (CIEF or CSDS) and Empower software, with opportunities to contribute to method transfer and regulatory-aligned testing in a

Qualifications

• Third level qualification in a scientific/technical discipline.
• One to Four years’ experience in a laboratory-testing environment within the biological and/or pharmaceutical industry.
• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
• Desirable: ability to apply knowledge of scientific theories, principles, and techniques used in biological test procedures.

Responsabilités

• Clinical release and stability testing of high-volume clinical products, sample processing, data interpretation, data trending, instrumentation troubleshooting, and GMP peer reviews.
• Achieves competency in TDS AD laboratory methods and procedures.
• Performs routine and non-routine analytical testing activities.
• Review and approval of laboratory test results where appropriate.
• Ensures testing and results approval are completed within agreed turnaround times; identify trending of results.

Connaissances

Laboratory skills

CIEF/CSDS experience

HPLC experience

Data interpretation

Microsoft Office

Formation

Third level qualification in a scientific/technical discipline

Outils

Empower

Description du poste

Separations Sciences Associate Scientist

Location: Barnahely (On-site)

Duration: 12 months

Hours: Shift-based on a 2-week cycle with 12-hour shifts (7:00 AM – 7:00 PM)

Imagine your next project working in a busy R&D/GMP laboratory environment with clinical products, receiving specialized training on specific assays and software with support from subject matter experts.

Department: Therapeutics Analytical Development (TDS-AD), combining R&D with routine GMP lab testing in the Capillaries team.

This position is responsible for carrying out tasks and projects related to TDS AD activities in Separation Sciences at Janssen Sciences Ireland UC (JSI) as required by Good Manufacturing Practice (GMP). Partners with other departments to ensure that all TDS AD activities are completed in an efficient manner. Part of a 15-person team working across desk and laboratory spaces, supported by subject matter experts.

roles and responsibilities

• Clinical release and stability testing of high-volume clinical products, sample processing, data interpretation, data trending, instrumentation troubleshooting, and GMP peer reviews.
• Achieves competency in TDS AD laboratory methods and procedures.
• Performs routine and non-routine analytical testing activities.
• Review and approval (where appropriate) of laboratory test results.
• Ensures that testing and results approval are completed within agreed turnaround times. Identify trending of results as required.
• Work as authorized personnel for handling of controlled substance as per laboratory procedures, where applicable.
• Performs analytical testing activities in relation to method validation and technical transfer activities so as to ensure that all methods meet ICH, CFR, USP and EP guidelines as per TDS AD laboratory methods and procedures.
• Escalate any non-conformances noted immediately to the TDS AD Team Lead. Complete non-conformances / deviations in an accurate and timely manner.
• Initiate Quality Issues identified, participate in the investigation, perform investigation analysis and provide necessary information to enable implementation of effective CAPA.
• Executes validation, operation, maintenance, calibration and troubleshooting of equipment and its associated software.
• Ensure laboratory equipment and instruments are properly maintained via execution of calibration and preventive maintenance program.
• Promotes a continuous improvement culture and providing leadership in this area.
• Ensure 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 the TDS AD group and provide assistance with other group activities as required and communicates relevant issues to the TDS AD Team Leader and Manager.
• Maintains and develops knowledge of analytical technology as well as cGMP Standards.

how to succeed

• Training will be provided on specific assays (CIEF or CSDS) and software (Empower). Candidates with HPLC or CIEF experience are ideal, but college graduates or those with food industry backgrounds will also be considered.
• A third level qualification in a scientific/technical discipline required.
• One to Four years’ experience in a laboratory-testing environment within the biological and/or pharmaceutical industry.
• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
• Demonstrated knowledge and testing experience in an FDA/IMB approved QC laboratory.
• Compliance with the cGMP, GMP, EHS, WWRIM, AE/PQC, IAPP and other local legal and/or regulatory requirements.
• Desirable: Demonstrated ability to apply knowledge of scientific theories, principles, and techniques used in biological test procedures.
• Proficient in using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint).
• Cooperate efficiently with the different partners.

This role offers a very competitive hourly rate. This contract will run for 12 months with an opportunity for extension

you are welcome here

Johnson & Johnson Innovative Medicine is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson Innovative Medicine

Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow. Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina. We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.