Senior Scientist, Reference Standard Process Owner Full-time NEW

Reference Standard Process Owner

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.

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.

We are looking for a Reference Standard Process Owner for the Analytical Method and Stability Center to be based in Beerse, Belgium.

Janssen R&D, a member of Johnson & Johnson's Family of Companies, is recruiting for a Reference Standard Process Owner for the Analytical Method and Stability Center (AMSC), located in Beerse, Belgium. AMSC is a critical part of the Global Analytical Development department in the Therapeutics Development and Supply (TDS) organization within Janssen R&D. We are a diverse and enthusiastic team of scientists that focus on developing and validating innovative analytical methods to analyze and provide (non-) clinical release and manufacturing/characterization support for Drug Substances (DS) and Drug Products (DP) for small molecules and new modalities. Additionally, we build up scientific understanding of the corresponding stability behaviours of the DS/DP to enable drug development and are responsible for the end-to-end lifecycle management of reference standards.

To further strengthen our team, we are looking for a highly motivated Reference Standard Process Owner who is inspired by the unmatched opportunity to help transforming patients' lives. The successful candidate will be responsible for the overall reference standard certification and stock management for both R&D and commercial J&J compounds and will work together with a team of Reference Standard Owners, R&D project teams and stakeholders within the commercial organization.

Key Responsibilities:

• Owner of processes related to certification and stock management of reference standards
• Coach and support the Reference Standard Owners, who are responsible for all activities related to the generation of reference standard Certificates of Analysis
• Ensure a suitable certification strategy for each compound. Ensure compliance with all relevant GMP regulations and safety guidance
• Manage reference standard stock, including controlled substances, maintaining appropriate inventory levels
• Lead process improvement initiatives
• Represent the Reference Standard Team in cross-functional workgroups and act as subject matter expert for assigned processes
• Lead and contribute to investigations addressing quality issues
• Build and manage internal and external relationships to facilitate efficient collaboration

Qualifications, Experience and Skills:

• You hold minimally a master's degree in sciences or equivalent experience with at least 4 years of applicable industry experience
• Knowledge and experience of analytical techniques required for drug substance characterization
• Flexible and adapt quickly to constantly evolving business needs
• Good organizational skills with the ability to plan and anticipate deadlines and deliverables
• Knowledge of cGMP regulations and guidelines
• Good written and verbal communication skills in English

Ready to make an impact?

If you want to leave your personal mark and be valued for who you are, Johnson & Johnson offers an unusual experience to professionals looking for an opportunity to work with hardworking people who share your real passion for caring in an environment that empowers to drive your own career and where you can bring your whole self to work.

We provide an environment to fulfill your career aspirations as well as promoting your physical and mental wellbeing. You will receive a competitive compensation and benefits package as well as benefits that can be tailored to what is valuable throughout different stages of your life.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.

Janssen Research & Development, discovers and develops innovative medical solutions to address meaningful unmet medical needs in oncology, immunology, neuroscience, cardiovascular and metabolic diseases and global public health.

The anticipated base pay range for this position is: €72,500.00 – €115,230.00

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.