13 дней назад
Experienced Scientist, Biotherapeutics R&D
52 400 - 82 915€
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Experienced Scientist, Biotherapeutics R&D (Biotherapeutics/Analytical Development): Supporting biotherapeutic development programs and analytical testing in a GMP laboratory with an accent on method transfer, validation, and laboratory operations. Focus on troubleshooting qualified equipment, investigating deviations and CAPA activities, and ensuring compliant analytical results under FDA, EMA, ICH, CFR, USP, and EP requirements.
Location: Ringaskiddy, Cork, Ireland; hybrid work with 3 days per week onsite required
Salary: €52,400–€82,915 annually
Company
Johnson & Johnson develops healthcare, Innovative Medicine, and MedTech solutions focused on preventing and treating complex diseases.
What you will do
- Perform routine and non-routine analytical testing for biotherapeutic development programs in a GMP environment.
- Support analytical method transfer, validation, and compliance with ICH, CFR, USP, EP, FDA, and EMA requirements.
- Review results, identify trends, and escalate non-conformances, deviations, and other issues within required timelines.
- Execute equipment validation, calibration, maintenance, troubleshooting, and IQ, OQ, and PQ protocols.
- Prepare and review methods, SOPs, work instructions, protocols, technical reports, and other laboratory documentation.
- Contribute to CAPA implementation, audit readiness, continuous improvement, and coaching of junior colleagues.
Requirements
- Bachelor’s, Master’s, or advanced degree in a scientific or technical discipline.
- Typically 2–4 years of experience in laboratory testing, analytical development, biologics, or pharmaceuticals.
- Experience in GMP or cGMP laboratory environments, including analytical testing, method transfer, and validation.
- Ability to commute to Ringaskiddy, Cork, is essential.
- Knowledge of regulatory requirements relevant to biologics and pharmaceuticals, including FDA and EMA standards.
- Strong scientific, written, verbal, collaboration, problem-solving, and attention-to-detail skills.
Nice to have
- Experience in separation sciences or analytical development within biopharmaceutical or biologics settings.
- Experience with non-conformances, investigations, deviations, and CAPA activities.
- Experience coaching colleagues and building cross-functional working relationships.
- Proficiency with Microsoft Office applications.
Culture & Benefits
- Flexible working environment supporting work-life balance.
- Career development opportunities.
- Annual bonus with a target based on pay grade and location.
- Vacation, parental, bereavement, caregiver, and volunteer leave.
- Well-being reimbursement and financial, physical, and mental health programs.
- Insurance plans and service anniversary and recognition awards, subject to plan terms.
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