Principal Scientist, Extractables & Leachables (E&L)

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About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.

Learn more at are searching for the best talent for Principal Scientist Extractables & Leachables (E&L) to be in Beerse.

Purpose:

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 drugdevice 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:

• Proposes scientifically justified solutions to address complex or non-standard issues

• Independently designs and critically evaluates complex E&L study strategies (eg. low AET UF determination etc) aligning study design with regulatory expectations and program needs

• Proactively identifies potential gaps inconsistencies and risks in study design and data interpretation

• Interprets LCMS and GCMS data and support 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 (eg. USP ISO 10993 FDA guidances PQRIetc) to continuously improve E&L approaches

Qualifications / Requirements:

• Ph.D. in Chemistry (Analytical preferred) with 4 years relevant experience OR Masters with 6 years OR Bachelors with 8 years

• Demonstrated experience designing and critically evaluating E&L studies for container closure systems and/or drugdevice 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

Preferred:

• 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 study execution and the use of generated data to support regulatory submissions

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The anticipated base pay range for this position is:

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 locations 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.