Principal Scientist II - Extractables & Leachables

A Principal Scientist II - Extractables and Leachables (E&L) is accountable for driving results in a fast-paced environment by performing analytical routine and non-routine testing in support of pharmaceutical product development or pharmaceutical manufacturing. A Principal Scientist II will routinely lead method development/method validation projects. The Principal Scientist II will support Extractables and Leachables (E&L) testing for pharmaceutical products. This role focuses on trace level analysis to identify compounds that may leach from manufacturing components and container closure systems into liquid formulations, supporting patient safety and regulatory compliance. This is a hands on, mass spectrometry driven position emphasizing method development and GMP rigor. On-Site Expectations:

• 100% on-site position.
• 1st Shift: Monday - Friday, 8:00am - 5:00pm.

Responsibilities:

• Execute extractables and leachables studies to identify potential migrants from packaging and manufacturing materials
• Develop, optimize, and validate chromatography and mass spectrometry based methods for trace analysis
• Interpret complex analytical data and support identification of unknown compounds
• Generate and maintain GMP compliant documentation, protocols, and reports
• Participate in client interactions, audits, and technical discussions
• Support investigations, deviations, and root cause analyses
• Other duties as assigned.

Technical Focus:

• LC/MS for nonvolatile compounds
• GC/MS (direct injection and headspace) for semi volatile and volatile compounds
• ICP-MS for elemental impurities (supporting scope)

Do you have experience in Technical writing?, Do you have a Master’s degree?, * Bachelor’s degree in Chemistry, Biology, or related field with 18+ years GMP related experience; OR Master’s degree in related field with 14+ years related experience; OR PhD in related field with 13+ years related experience.

• Experience in Pharmaceutical, CDMO, or cGMP preferred.

Knowledge, Skills, and Abilities:

• Excellent verbal and written communication and documentation skills required.
• Excellent detail orientation and organizational skills required.
• Excellent problem-solving and basic trouble-shooting ability required.
• Excellent knowledge of laboratory equipment and safety required.
• Expert knowledge of Laboratory Documentation is required.
• Ability to develop and implement new methods/processes required.
• Ability to plan and manage multiple tasks for timely achievement of results.
• Working knowledge of cGMP in a pharmaceutical or regulated environment required.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint) required.
• Hands on experience with GC and/or HPLC method development and validation.
• Strong attention to detail and proficiency with GMP documentation.
• Experience with Extractables and Leachables studies.
• Mass spectrometry experience (LC/MS or GC/MS).
• Experience identifying unknown peaks using mass spectral data.
• Familiarity with trace analysis and regulatory expectations for E&L.

Travel Expectations:

• Up to 5% domestic travel.