Senior Biologics Analytical Development Scientist (CMC)

Integrated Resources, Inc ( IRI ); United States; On-site; USD 120,000 - 160,000; Full time

Job summary

Integrated Resources, Inc seeks a Senior Scientist, Biologics Analytical Development to lead analytical method development for recombinant protein processes and biologics characterization. You will support microbial and mammalian systems, contribute to process development, tech transfers, and regulatory documentation.

The role requires at least a PhD in a relevant field, strong experience with MS, HPLC, and biophysical methods, and the ability to collaborate across cross-functional teams in a

Qualifications

• PhD required or equivalent with significant biology/pharma experience.
• Experience developing biologics analytical methods in biotech/pharma.
• Familiarity with GMP/regulated environments and regulatory submissions.

Responsibilities

• Develop, optimize, and qualify analytical methods for biologic products.
• Characterize proteins and conjugates using LC-MS, HPLC, and biophysical techniques.
• Support process development through upstream/downstream analytics and tech transfer.

Skills

Analytical method development

Mass spectrometry

HPLC

Protein characterization

Regulatory documentation

CMC knowledge

Team leadership

Excellent communication

Problem solving

Regulatory submissions

Education

PhD in biotech/engineering

Equivalent experience

Postdoctoral experience considered

Tools

CDS software

Regulatory databases

Job description

Integrated Resources, Inc seeks a Senior Scientist, Biologics Analytical Development to lead analytical method development for recombinant protein processes and biologics characterization. You will support microbial and mammalian systems, contribute to process development, tech transfers, and regulatory documentation.

The role requires at least a PhD in a relevant field, strong experience with MS, HPLC, and biophysical methods, and the ability to collaborate across cross-functional teams in a