Ph3Overview /h3pPrincipal Scientist, Extractables Leachables (EL) within Drug Delivery Systems (DDS) at Johnson Johnson (Beerse, Belgium). The role provides technical expertise in the design, execution, and critical evaluation of EL 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 EL 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. /ph3Responsibilities /h3ulliProposes scientifically justified solutions to address complex or non-standard issues. /liliIndependently designs and critically evaluates complex EL study strategies (e.g., low AET, UF determination), aligning study design with regulatory expectations and program needs. /liliProactively identifies potential gaps, inconsistencies, and risks in study design and data interpretation. /liliInterprets LC–MS and GC–MS data and supports the preparation of high-quality technical reports and regulatory documentation. /liliSupports regulatory activities by contributing to scientific justifications and responses. /liliManages contract laboratories to ensure data quality, appropriate study execution, and timely delivery. /liliApplies state-of-the-art knowledge (e.g., USP, ISO 10993, FDA guidances, PQRI) to continuously improve EL approaches. /li /ulh3Qualifications / Requirements /h3ulliPh.D. in Chemistry (Analytical preferred) with 4+ years relevant experience OR Master’s with 6+ years OR Bachelor’s with 8+ years. /liliDemonstrated experience designing and critically evaluating EL studies for container closure systems and/or drug–device combination products and/or medical devices. /liliStrong expertise in interpretation of complex LC-MS and GC-MS datasets. /liliProven ability to apply scientific judgement to assess study adequacy, identify gaps, and resolve complex technical challenges. /liliSolid understanding of global EL regulatory expectations and guidance (e.g., USP 1663/1664, ISO 10993, PQRI, FDA, etc.). /liliExperience working effectively with cross-functional teams and external laboratories. /liliStrong proficiency in data analysis and processing tools, including management of large analytical datasets and critical data interpretation. /liliStrong communication and problem-solving skills. /li /ulh3Preferred Skills /h3ulliExperience with drug-device combination products and/or medical devices testing, including exhaustive extractions. /liliExperience contributing to regulatory submissions or responses to health authority questions. /liliExperience overseeing CROs and critically evaluating analytical method performance and study execution, and using generated data to support regulatory submissions. /li /ulh3Benefits /h3pThe anticipated base pay range for this position is: €79,800.00 - €137,770.00 /pulliAnnual bonus with target (%) based on pay grade/location and performance. /liliVacation days, parental leave, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement. /liliPrograms for financial, physical, and mental health; service anniversaries and recognition awards; eligible dependent coverage in some locations. /li /ulh3Location /h3pBeerse, Antwerp, Belgium. /p /p #J-18808-Ljbffr