Senior/Principal Scientist

Within Johnson & Johnson Innovative Medicine, we are recruiting a Senior/Principal Scientist with strong skills in quantitative mass spectrometry for the determination of trace-level organic impurities such as N-nitrosamines.

The Senior/Principal Scientist will join the Advanced Materials Characterization and Investigations (AMCI) group within AD. AMCI is an international and diverse multidisciplinary team of scientists leading advanced characterization and mechanistical understanding of our drug substances and drug products. We are also leading analytical investigations for commercial and R&D portfolio.

Within AMCI, the Advanced Molecular Analysis (AMA) team is a group of analytical centers of excellence in structure elucidation (by high-resolution mass spectrometry and NMR), organic and inorganic trace analysis, polymer characterization, and ADC, oligonucleotide & peptide analytics.

We are currently seeking a skilled and enthusiastic Scientist with a strong background in quantitative mass spectrometry to join our AMA team, where you will play a crucial role in our mission to quantify trace-level organic impurities across various matrices and pharmaceutical products. This laboratory-based position offers you the opportunity to lead the development and implementation of innovative analytical test methods for several types of impurities including N-nitrosamines. In this role, you will also collaborate closely with internal and external specialists to conduct thorough root cause investigations and explore innovative approaches for optimal analyses. If you are passionate about pushing the boundaries of analytical techniques and eager to make a significant impact in the field, we would love to hear from you!

The position is based in Antwerp, Belgium.

Johnson & Johnson Innovative Medicine develops treatments that improve the health and lifestyles of people worldwide. Our development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, pulmonary hypertension and reproductive medicine. The successful candidate will be employed in our Analytical Development (AD) organization, responsible for Global Therapeutics Development and Supply (TDS) Organization.

Key Responsibilities:

• Design, develop, validate, and transfer advanced LC-HRMS and QqQ methods for quantifying trace level organic impurities, such as N-nitrosamines across diverse matrices, in accordance with regulatory guidelines and company standards.
• Independently troubleshoot mass spectrometry systems.
• Lead comprehensive root cause investigations related to trace level organic impurities within our R&D portfolio, from the early stages through to late development. Your contributions will be pivotal to process improvement initiatives and enhancing product quality.
• Utilize cutting-edge scientific knowledge to guarantee the delivery of high-quality results, strengthening our position as leaders in quantitative analyses.
• Initiate and lead partnerships with universities and other research institutions to expand our external innovation network, fostering collaboration that enhances our capabilities and expertise.

Qualifications

• A PhD degree in analytical chemistry or related field; or a master’s degree in related science with a minimum of 6 years of experience. Work-related experience in pharmaceutical R&D is an asset.
• Proven in-depth expertise in quantitative mass spectrometry is essential for this role.
• Demonstrated experience in the quantitation of N-nitrosamines in pharmaceutical products is a significant advantage.
• Familiarity with developing chromatographic methods is preferred.
• Knowledge of regulatory frameworks (e.g., ICH, EMA, FDA) and GMP guidelines, particularly concerning validation requirements, is an advantage.
• Excellent English communication skills, both written and spoken, allowing for effective scientific discussions and collaboration.

Preferred Skills:

Budget Management, Chemistry, Manufacturing, and Control (CMC), Clinical Trial Protocols, Critical Thinking, Cross-Functional Collaboration, Drug Discovery Development, Industry Analysis, Interdisciplinary Work, Market Research, Organizing, Pharmacokinetic Modeling, Process Improvements, Product Development, Product Strategies, Report Writing, Safety-Oriented, Scientific Research