Senior Scientist, Extractables & Leachables Expert

Alcami Corporation; Wilmington (NC); On-site; USD 120,000 - 170,000; Full time

Job summary

Alcami Corporation is seeking a Sr. Scientist III - Extractables & Leachables to drive method development and validation in a fast-paced pharmaceutical setting. This role involves LCMS/GCMS testing, data interpretation, and ensuring cGMP compliance across projects.

The candidate will lead investigations, support audits, and maintain instrumentation knowledge while solving complex analytical challenges. On-site, first shift, with travel up to 5%.

Qualifications

• Pharmaceutical experience with cGMP required.
• CDMO experience is preferred.
• Strong analytical skills and ability to develop and validate methods.

Responsibilities

• Lead method development and validation projects.
• Perform LCMS/GCMS based testing and data analysis.
• Ensure compliance with cGMP and audits.
• Maintain instrument readiness and troubleshoot.
• Interacts with clients and regulatory agency audits.

Skills

Detail orientation

Problem solving

Verbal and written communication

GMP/documentation proficiency

Troubleshooting

Time management

Microsoft Office

Education

Bachelor’s degree in Chemistry

Master’s degree in Chemistry

Ph.D. in Chemistry or related field

Tools

GC/MS

LC/MS

HPLC method development/validation

Empower3

ProCal

Master Control

ELN

Job description

Alcami Corporation is seeking a Sr. Scientist III - Extractables & Leachables to drive method development and validation in a fast-paced pharmaceutical setting. This role involves LCMS/GCMS testing, data interpretation, and ensuring cGMP compliance across projects.

The candidate will lead investigations, support audits, and maintain instrumentation knowledge while solving complex analytical challenges. On-site, first shift, with travel up to 5%.