Analytical Development Scientist – Biologics, cGMP Expert

SAB BIO; Sioux Falls (SD); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

SAB BIO is seeking an Analytical Development Scientist to drive day-to-day laboratory performance and ensure data integrity for biologics programs from early phase to regulatory submission. You will lead method development, validation, and transfer, while maintaining cGMP standards and collaborating with cross-functional teams.

The role emphasizes analytical readiness for late-stage development, regulatory submissions, and commercial launch, with opportunities to work with external partners and

Qualifications

• Bachelor's degree in life sciences or related field with relevant experience.
• Hands-on lab expertise in analytical methods and cGMP knowledge.
• Experience with method validation, transfer, and regulatory guidelines such as ICH/FDA.

Responsibilities

• Lead method development, validation, transfer to internal/external labs, and lifecycle management.
• Ensure analytical readiness for late-stage development, PPQ, and commercial launches.
• Maintain cGMP compliance, data integrity, and regulatory documentation.

Skills

Data analysis

Technical writing

Microsoft Office

Analytical thinking

Education

Bachelor's degree in life sciences

Master's degree (preferred)

Tools

A280

HPLC

CE-SDS

CIEF

LC-MS

Job description

SAB BIO is seeking an Analytical Development Scientist to drive day-to-day laboratory performance and ensure data integrity for biologics programs from early phase to regulatory submission. You will lead method development, validation, and transfer, while maintaining cGMP standards and collaborating with cross-functional teams.

The role emphasizes analytical readiness for late-stage development, regulatory submissions, and commercial launch, with opportunities to work with external partners and