Exp Sci Biotherapeutics RD
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What you'll do
- Performing routine and non-routine analytical testing activities in line with laboratory methods and procedures
- Reviewing laboratory test results, where appropriate, and ensuring testing and approvals are completed within agreed turnaround times
- Identifying result trends and escalating non-conformances or deviations promptly to the team lead
- Supporting the execution of Biotherapeutics R&D projects and development programs as a developing individual contributor
- Supporting method transfer and validation activities to ensure methods meet applicable ICH, CFR, USP, and EP guidelines
- Initiating and supporting non conformances, contributing analysis, and providing information to enable effective CAPA implementation
- Executing validation, operation, maintenance, calibration, and troubleshooting of laboratory equipment and associated software
- Supporting execution and review of IQ, OQ, and PQ protocols to ensure equipment is qualified for cGMP use
- Ensuring laboratory instruments and equipment are maintained through calibration and preventive maintenance programmes
- Writing and reviewing laboratory documents, including technical methods, SOPs, work instructions, protocols, and technical reports as relevant
- Recommending improvements to standard procedures and contributing to a continuous improvement culture within R&D
- Maintaining training compliance and performing tasks only after completion of required training on current effective procedures
What they're looking for
- A Bachelor’s, Master’s, or advanced degree in a scientific or technical discipline is required
- Typically requires 2 to 4 years of experience in a laboratory testing, analytical development, biologics, or pharmaceutical environment
- Knowledge of FDA, EMA, and other applicable regulatory requirements relevant to biologics and/or pharmaceuticals is required
- Experience in GMP or cGMP laboratory environments, including analytical testing, method transfer and validation is required
- Demonstrated knowledge of scientific theories, principles, and techniques used in biological or pharmaceutical analytical test procedures is required
- Strong written and verbal communication skills and the ability to work effectively across functions are required
- Commutability to Ringaskiddy, Cork is essential
Nice to have
- Experience performing progressively advanced responsibilities at Scientist level is preferred
- Experience in Separation Sciences or analytical development within a biopharmaceutical or biologics setting
- Experience supporting non-conformances, investigations, deviations, and CAPA activities
- Proficiency with Microsoft Office applications, including Outlook, Excel, Word, and PowerPoint
- Strong collaboration, problem-solving, and attention to detail
- Ability to influence, coach, and build productive working relationships across a diverse organisation
- Adaptability, sound judgement, and a continuous improvement mindset
- Commitment to integrity, inclusion, and the highest standards of ethical behaviour
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Discovery & Pre-Clinical/Clinical DevelopmentJob Sub Function:
Biotherapeutics R&DJob Category:
Scientific/TechnologyAll Job Posting Locations:
Ringaskiddy, Cork, IrelandJob Description:
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at https://www.jnj.com
About Innovative Medicine:
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine
We are searching for the best talent for an Experienced Scientist, Biotherapeutics R&D to be located in Ringaskiddy, Cork, Ireland (Flex working: 3 days per week onsite required)
Purpose:
We are seeking an experienced scientist to support Biotherapeutics R&D development programs and analytical development activities in TDS AD Cork Separation Sciences. This role will contribute to the execution of biotherapeutic projects, analytical testing, method transfer and validation, and laboratory operations in a GMP environment, while partnering across functions to deliver high-quality, efficient, and compliant outcomes.
You Will Be Responsible For:
- Performing routine and non-routine analytical testing activities in line with laboratory methods and procedures
- Reviewing laboratory test results, where appropriate, and ensuring testing and approvals are completed within agreed turnaround times
- Identifying result trends and escalating non-conformances or deviations promptly to the team lead
- Supporting the execution of Biotherapeutics R&D projects and development programs as a developing individual contributor
- Supporting method transfer and validation activities to ensure methods meet applicable ICH, CFR, USP, and EP guidelines
- Initiating and supporting non conformances, contributing analysis, and providing information to enable effective CAPA implementation
- Executing validation, operation, maintenance, calibration, and troubleshooting of laboratory equipment and associated software
- Supporting execution and review of IQ, OQ, and PQ protocols to ensure equipment is qualified for cGMP use
- Ensuring laboratory instruments and equipment are maintained through calibration and preventive maintenance programmes
- Writing and reviewing laboratory documents, including technical methods, SOPs, work instructions, protocols, and technical reports as relevant
- Recommending improvements to standard procedures and contributing to a continuous improvement culture within R&D
- Maintaining training compliance and performing tasks only after completion of required training on current effective procedures
- Supporting audit readiness and general laboratory support activities as required
- Contributing as an active member of the team, communicating relevant issues to leadership, and assisting with broader group activities as needed
- Coaching more junior colleagues in techniques, processes, and responsibilities
- Applying Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions and decision-making
Are you ready to join our team? Please read further!
Education and Experience Requirements:
- A Bachelor’s, Master’s, or advanced degree in a scientific or technical discipline is required
- Typically requires 2 to 4 years of experience in a laboratory testing, analytical development, biologics, or pharmaceutical environment
- Experience performing progressively advanced responsibilities at Scientist level is preferred
- Knowledge of FDA, EMA, and other applicable regulatory requirements relevant to biologics and/or pharmaceuticals is required
- Experience in GMP or cGMP laboratory environments, including analytical testing, method transfer and validation is required
- Demonstrated knowledge of scientific theories, principles, and techniques used in biological or pharmaceutical analytical test procedures is required
- Strong written and verbal communication skills and the ability to work effectively across functions are required
- Commutability to Ringaskiddy, Cork is essential
Preferred Experience & Skills
- Experience in Separation Sciences or analytical development within a biopharmaceutical or biologics setting
- Experience supporting non-conformances, investigations, deviations, and CAPA activities
- Proficiency with Microsoft Office applications, including Outlook, Excel, Word, and PowerPoint
- Strong collaboration, problem-solving, and attention to detail
- Ability to influence, coach, and build productive working relationships across a diverse organisation
- Adaptability, sound judgement, and a continuous improvement mindset
- Commitment to integrity, inclusion, and the highest standards of ethical behaviour
Benefits:
We offer a competitive salary and extensive benefits package. The health and well-being of our employees is a priority, we have a flexible working environment as we value work-life balance. We offer career development opportunities for those who want to grow and be part of our organization.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will be considered for employment without regard to any other characteristic protected by law.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform important job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
#DPDS
Required Skills:
Preferred Skills:
Analytical Reasoning, Biochemistry, Chemistry, Manufacturing, and Control (CMC), Coaching, Collaboration, Conducting Experiments, Data Quality, Drug Discovery Development, Molecular Diagnostics, Patent Applications, Pharmacogenetics, Report Writing, Research Documents, Scientific Research, Technologically Savvy, Written Expression
The anticipated base pay range for this position is:
€52,400.00 - €82,915.00
Benefits:
In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.
*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.
Company
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