Principal Biologics Scientist - Lead Process Development

Jobgether; United States; On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Competitive salary

Annual performance-based bonus

Equity-based incentive program

Generous vacation allowance

Paid wellness days

Learning and development support

International, multidisciplinary team

Job summary

Jobgether is seeking a Principal Scientist, Biologics in the United States to lead cross‑functional biologics development and manufacturing readiness for clinical materials. You will guide process development, ensure GMP/CMC compliance, and contribute to regulatory filings and technology transfer.

The role requires a PhD with 8+ years in GMP environments, strong communication skills, and the ability to manage complex projects with internal and external teams worldwide.

Qualifications

• PhD with extensive experience in biologics development and GMP/CMC.
• Experience leading cross-functional teams across analytical sciences, purification, formulation, and bioconjugation.

Responsibilities

• Lead biologics development projects across multiple technical areas for clinical drug substance.
• Review manufacturing documentation and ensure GMP/compliance.
• Author CMC content for regulatory submissions (IND, NDA, BLA).
• Coordinate technology transfer and process optimization with internal and external partners.
• Mentor scientists and lead cross‑functional collaboration.

Skills

GMP compliance

CMC knowledge

Biologics development

Project management

Regulatory submissions

Cross-functional collaboration

Mentoring

Education

PhD in a relevant field

Master’s degree in science/engineering

Bachelor’s degree in science/engineering

Job description

Jobgether is seeking a Principal Scientist, Biologics in the United States to lead cross‑functional biologics development and manufacturing readiness for clinical materials. You will guide process development, ensure GMP/CMC compliance, and contribute to regulatory filings and technology transfer.

The role requires a PhD with 8+ years in GMP environments, strong communication skills, and the ability to manage complex projects with internal and external teams worldwide.