Sr. Scientist I - Extractables & Leachables

Alcami Corporation

1d • Onsite

About The Position

The Senior Scientist I 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.

Requirements

• Bachelor’s degree in Chemistry with 8+ years of experience, or Master’s degree with 4+ years of experience, or Ph.D. with 2+ years of experience required.
• 2+ years of experience in Pharmaceuticals drug product development under cGMP is required.
• 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.

Nice To Haves

• CDMO experience is preferred.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1-10 employees