Senior iPSC Analytical Scientist — GMP QC

United Therapeutics Corporation; Silver Spring (MD); On-site; USD 93,000 - 123,000; Full time

Job summary

United Therapeutics Corporation in Silver Spring, MD, is seeking a Senior Analytical Specialist to maintain assay performance, support product release, and ensure compliance with GMP and company quality standards. The role involves in-process and release testing of iPSC banks, data review, and coordination with external labs.

Candidates should have a Bachelor's in biology or related field with 5+ years of analytical testing experience (or 3+ years with a Master’s).

Qualifications

• Bachelor’s degree in biology, molecular biology, immunology, or related field
• 5+ years of relevant experience in analytical testing with a Bachelor’s Degree or
• 3+ years of relevant experience in analytical testing with a Master’s Degree
• Proficiency in performing lot release assays and cell characterization assays
• GDP record keeping and familiarity with cGMP environments
• Strong written and verbal communication to interact cross-functionally

Responsibilities

• Perform in-process and release testing of iPSC banks, including flow cytometry, qPCR, STR, endotoxin, and ELISA, independently
• Author and/or review protocols, summary reports, and SOPs for testing and validation
• Coordinate testing activities with external contract laboratories and ensure regulatory compliance
• Support installation/operation/qualification of new equipment and draft/review protocols
• Maintain lab equipment calibration and troubleshoot instrumentation
• Maintain laboratory inventory and perform routine housekeeping
• Lead investigations for OOS results and execute CAPA as needed
• Serve as primary contact for routine testing status in manufacturing projects
• Train manufacturing operators on assay sample prep and equipment handling
• Analyze and present data results in weekly meetings
• All other duties as required

Skills

Strong written & verbal communication

Detail oriented

Independent worker

Cross-functional collaboration

Education

Bachelor's degree in biology or related field

Master's degree in biology or related field

Tools

Flow cytometry

qPCR

STR

ELISA

Job description

United Therapeutics Corporation in Silver Spring, MD, is seeking a Senior Analytical Specialist to maintain assay performance, support product release, and ensure compliance with GMP and company quality standards. The role involves in-process and release testing of iPSC banks, data review, and coordination with external labs.

Candidates should have a Bachelor's in biology or related field with 5+ years of analytical testing experience (or 3+ years with a Master’s).