Overview
Principal Scientist, Extractables & Leachables (E&L) within Drug Delivery Systems (DDS) at Johnson & Johnson (Beerse, Belgium). The role provides technical expertise in the design, execution, and critical evaluation of E&L studies for closure container systems and drug–device combination products. Operating independently within assigned programs, the position applies scientific judgement to define fit-for-purpose E&L approaches, resolve analytical questions, and ensure alignment with global regulatory expectations. The role partners with cross-functional teams and external laboratories to deliver robust, regulatory-relevant data and proactively identify risks to program progression or regulatory acceptability.
Responsibilities
* Proposes scientifically justified solutions to address complex or non-standard issues.
* Independently designs and critically evaluates complex E&L study strategies (e.g., low AET, UF determination), aligning study design with regulatory expectations and program needs.
* Proactively identifies potential gaps, inconsistencies, and risks in study design and data interpretation.
* Interprets LC–MS and GC–MS data and supports the preparation of high-quality technical reports and regulatory documentation.
* Supports regulatory activities by contributing to scientific justifications and responses.
* Manages contract laboratories to ensure data quality, appropriate study execution, and timely delivery.
* Applies state-of-the-art knowledge (e.g., USP, ISO 10993, FDA guidances, PQRI) 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 /, 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 and critical data interpretation.
* Strong communication and problem-solving skills.
Preferred Skills
* Experience with drug-device combination products and/or medical devices testing, including exhaustive extractions.
* Experience contributing to regulatory submissions or responses to health authority questions.
* Experience overseeing CROs and critically evaluating analytical method performance and study execution, and using generated data to support regulatory submissions.
Benefits
The anticipated base pay range for this position is: €79,800.00 - €137,770.00
* Annual bonus with target (%) based on pay grade/location and performance.
* Vacation days, parental leave, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement.
* Programs for financial, physical, and mental health; service anniversaries and recognition awards; eligible dependent coverage in some locations.
Location
Beerse, Antwerp, Belgium.
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