Principal Scientist, Extractables & Leachables (E&L) Full-time NEW

Principal Scientist, Extractables & Leachables (E&L)

The Principal Scientist, Extractables & Leachables (E&L), provides strong technical expertise in the design, execution, and critical evaluation of E&L studies for closure container systems and drug–device combination products within Drug Delivery Systems (DDS). Operating independently within assigned programs, the role applies deep scientific judgement to define fit-for-purpose E&L approaches, resolve complex analytical questions, and ensure alignment with evolving global regulatory expectations. The position partners closely with cross-functional teams and external laboratories to deliver robust, regulatory-relevant data and proactively identify risks that may impact program progression or regulatory acceptability.

You will be responsible for :

• Proposing scientifically justified solutions to address complex or non-standard issues
• Independently designing and critically evaluating complex E&L study strategies (eg. low AET, UF determination, etc), aligning study design with regulatory expectations and program needs
• Proactively identifying potential gaps, inconsistencies, and risks in study design and data interpretation
• Interpreting LC–MS and GC–MS data and supporting the preparation of high-quality technical reports and regulatory documentation
• Supporting regulatory activities by contributing to scientific justifications and responses
• Managing contract laboratories to ensure data quality, appropriate study execution, and timely delivery
• Applying state of the art knowledge (eg. USP, ISO 10993, FDA guidances, PQRI, etc) to continuously improve E&L approaches

Qualifications / Requirements:

• Ph.D. in Chemistry (Analytical preferred) with 4+ years relevant experience OR Master's with 6+ years OR Bachelor's with 8+ years
• Demonstrated experience designing and critically evaluating E&L studies for container closure systems and/or drug–device combination products and/or medical devices
• Strong expertise in interpretation of complex LC-MS and GC-MS datasets
• Proven ability to apply scientific judgement to assess study adequacy, identify gaps, and resolve complex technical challenges
• Solid understanding of global E&L regulatory expectations and guidance (e.g. USP <1663>/<1664>, ISO 10993, PQRI, FDA, etc)
• Experience working effectively with cross-functional teams and external laboratories
• Strong proficiency in data analysis and processing tools, including management of large analytical datasets, tracking of compounds, and critical data interpretation
• Strong communication and problem-solving skills

The anticipated base pay range for this position is:

€79,800.00 – €137,770.00

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.