Scientist

TDS AD Scientist

Location: Cork, Ireland

Duration: 12 month contract

Hours: 39

Imagine your next project playing a vital role in Separation Sciences at Janssen Sciences Ireland UC (JSI), ensuring the quality and efficiency of analytical development in a GMP environment.

This position is responsible for carrying out tasks and projects related 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. This position reports to the TDS AD Team Lead within the Therapeutics Development and Supply Analytical Development department. This position description is a general guideline for colleagues; it does not purport to be an exhaustive list of all elements of the position. Management reserves the right to modify this position description at any time, or to vary the duties and responsibilities of the position to meet production, scheduling, or other business needs.

roles and responsibilities. 

This position is responsible for carrying out tasks and projects related TDS AD activities in Separation Sciences at Janssen Sciences Ireland UC (JSI) as required by Good Manufacturing Practice (GMP).

This will involve: 

• 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 results as required. 

• Work as authorised personnel for handling of controlled substances 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 provides leadership in this area. 

• Ensure training is completed on time and all tasks are performed only after completion of training 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 provides 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. 

• Take reasonable care to protect his or her own and the safety of their colleagues who may be affected by their actions. 

• Comply with EHS rules and procedures at all times. 

• Understand the potential EHS impact of their activities. 

• Attend and participate in EHS training as required. 

• Use PPE and safety equipment as required. 

• Report all incidents, accidents, and near miss events. 

• Report unsafe plants, equipment, acts, procedures or issues. 

• Make suggestions to improve health and safety in the workplace. 

• Actively participate in work area EHS teams.

• Not turn a ‘blind eye’ to unsafe acts or situations. 

• All employees are required to comply with the requirements of the company’s Environmental, Health and Safety Policy, Safety Statement, associated EHS Procedures, local legislation and duties outlined in the site EHS Manual.

how to succeed. 

A third level qualification in a scientific/technical discipline with one to four years’ experience in a laboratory-testing environment within the biological and/or pharmaceutical industry; the hiring manager is also happy to accept applications from recent graduates.

You will also bring: 

• 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. 

• 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. 

• Collaboration and teamwork. 

• Strategic thinker. 

• Problem solving and attention to detail. Results and performance driven. 

• Coaching and mentoring style. Integrity, trustworthiness and objectivity. 

• Customer focus. 

• Clear communication skills. 

• Adaptable and flexible. 

• Innovative. Inclusive, facilitative style. 

• To work as a strategic partner with all other departments within the company. 

• Builds strong productive relationships. 

• Demonstrates ability to work with teams and individuals. 

• Asserts personal ideas and opinions using persuasion to influence others. 

• Seeks opportunities to grow and develop professionally. 

• Uses best practices to improve business operations. 

• Works effectively with people that have diverse styles, talents and ideas. 

• Attention to detail. 

• Good problem solving skills. 

• Interface with all site departments as required. 

• Excellent interpersonal skills. 

• The ability to operate as part of a team is critical. 

• Excellent communication skills both written and verbal. 

• Holds self accountable for compliant and flawless execution. 

• Takes personal responsibility for decisions that successfully build customer value. 

• Effectively manages and adapts to change. 

• Demonstrates the courage to stand alone on ideas and opinions that differ from others. Listens effectively and remains open to other’s ideas. 

• Maintains the highest standards of ethical behaviour. 

• Treats people with dignity and respect. 

• A waiver may be granted in exceptional circumstances for individuals who are not performing those tasks requiring the above qualifications and experience. 

• This would be at the discretion of the TDS AD Team Leader in conjunction with TDS AD Associate Director.

Benefits.

 This role offers a very competitive hourly rate. This contract will run for 12 months.

you are welcome here. 

Johnson & Johnson 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.

application process. 

We are looking to process the first round of applications within the next 2 working days. We do not accept applications via email.

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”.