Bioassay QC Senior Analyst: Method Transfers & GMP

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading biopharmaceutical company in North Carolina is seeking a Senior Analyst 1 for QC Analytical Development Bioassay. This role involves executing analytical method transfers, ensuring compliance with GMP regulations, and collaborating across teams to meet project timelines. The ideal candidate will have a Bachelor's degree in a related field and experience in Bioassay testing methods. This position offers opportunities to work on diverse projects in a dynamic environment.

Qualifications

• 2+ years of analytical laboratory experience preferably in Biotechnology or Pharma.
• 1+ years of experience in a GMP environment.
• Experience with QC Bioassay testing methods including ELISA and Dot Blot.

Responsibilities

• Executes analytical method transfers and validations for Bioassays.
• Ensures compliance of analytical testing with GMP regulations.
• Authors and reviews SOPs, protocols, and technical reports.

Skills

Analytical method transfers

GMP compliance

Cross-functional collaboration

SOP authorship and review

QC Bioassay testing methods

Education

Bachelor’s Degree in Microbiology, Virology, Biology, or related science

Master’s Degree in Virology, Microbiology, Biology, or related science

Job description

A leading biopharmaceutical company in North Carolina is seeking a Senior Analyst 1 for QC Analytical Development Bioassay. This role involves executing analytical method transfers, ensuring compliance with GMP regulations, and collaborating across teams to meet project timelines. The ideal candidate will have a Bachelor's degree in a related field and experience in Bioassay testing methods. This position offers opportunities to work on diverse projects in a dynamic environment.