QC Analytical Development Scientist, Biologics

Rentschler Biopharma, Inc.; Milford (MA); On-site; USD 123,984,000 - 151,536,000; Full time

Job summary

Rentschler Biopharma, Inc. seeks a Scientist for Quality Control Analytical Development on a 6-month contract at the Milford, MA site. The role focuses on validating molecular biology assays such as ELISA for residual HCP, relative potency, and qPCR, under cGMP in collaboration with QC.

You will transfer methods to QC GMP labs, develop protocols, and train team members while maintaining rigorous documentation and safety standards.

Qualifications

• Bachelor's degree in chemistry or biological sciences with 5+ years in a cGMP setting.
• Experience validating/qualifying analytical methods for biologics.
• Strong understanding of molecular biology assays used in QC.
• Ability to train others and write SOPs and reports.

Responsibilities

• Support qualification/validation of analytical methods for biologic drugs.
• Execute experiments for ELISA, qPCR, and related potency assays.
• Collaborate with QC and method transfer teams for GMP-compliant transfers.
• Review SOPs, write protocols, and train staff as needed.

Skills

Molecular biology

qPCR

ELISA (HCP)

Cell biology

Immunochemistry

GMP compliance

Communication

Education

Bachelor's degree in chemistry or biological sciences

Master's degree (preferred)

Tools

Spectramax M5

Spectramax M2

SoftMax Pro/SoftMax GMP

Data analysis software

Job description

Rentschler Biopharma, Inc. seeks a Scientist for Quality Control Analytical Development on a 6-month contract at the Milford, MA site. The role focuses on validating molecular biology assays such as ELISA for residual HCP, relative potency, and qPCR, under cGMP in collaboration with QC.

You will transfer methods to QC GMP labs, develop protocols, and train team members while maintaining rigorous documentation and safety standards.