Overview
Do not wait to apply after reading this description a high application volume is expected for this opportunity.
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. xlxgzvr
Location
Beerse, Antwerp, Belgium.
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