Senior Biologics Analytics Scientist - Process & Methods

Integrated Resources, Inc ( IRI ); United States; On-site; USD 110,000 - 185,000; Full time

Job summary

Integrated Resources, Inc ( IRI ) seeks a Senior Scientist, Biologics Analytical Development to drive analytical method development and protein characterization for biologic therapeutics.

The role involves supporting upstream/downstream process development, technology transfer to CROs/CMOs, and contribution to GMP regulatory documents. Strong leadership and cross-functional collaboration are essential.

Qualifications

• PhD in a scientific or engineering discipline is required.
• Minimum 5 years' experience in biotechnology/pharmaceuticals, preferably in process development.
• Experience in FDA-regulated environments is preferred.
• Excellent written and verbal communication and collaboration skills.

Responsibilities

• Develop analytical methods for biologic products and qualify them.
• Characterize recombinant proteins and conjugates using LC-MS, SEC, IEX, CE-SDS, and biophysical techniques.
• Support upstream and downstream process development and tech transfer to CROs/CMOs.
• Prepare regulatory documentation and contribute to GMP manufacturing support.
• Lead projects, mentor team members, and provide training as needed.

Skills

Biologics development

Analytical method development

HPLC

Mass spectrometry

Protein characterization

Process development

Regulatory documentation

CMC/regulatory submissions

Team leadership

Education

PhD in a scientific or engineering discipline

Job description

Integrated Resources, Inc ( IRI ) seeks a Senior Scientist, Biologics Analytical Development to drive analytical method development and protein characterization for biologic therapeutics.

The role involves supporting upstream/downstream process development, technology transfer to CROs/CMOs, and contribution to GMP regulatory documents. Strong leadership and cross-functional collaboration are essential.