Lead, Analytical Development – Biologics

SAB; 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 Supervisor in the ADQC department to drive day-to-day lab performance, ensuring cGMP, regulatory compliance and data integrity. You will lead method development, transfer to internal/external labs, lifecycle management, and readiness for CMC milestones and regulatory submissions.

Relocation assistance is available. The role focuses on biologics programs from early phase to pivotal phase and commercialization, with collaboration across QA/QC and

Qualifications

• Bachelor's degree with 7+ years in life sciences or biotech/pharma.
• Master's degree highly desirable.
• Experience with A280, HPLC, CE-SDS, cIEF and LC-MS.

Responsibilities

• Lead and perform hands-on analytical work including method development, validation, transfer and lifecycle management.
• Ensure analytical readiness for late-stage development and regulatory submissions.
• Troubleshoot method performance, investigations, CAPA, and change control.
• Support qualification and stability monitoring of reference standards and reagents.
• Ensure compliance with cGMP, ICH, USP/EP and QbD in all activities.

Skills

A280

HPLC

CE-SDS

cIEF

LC-MS

ELISA

Cell potency assays

Statistical analysis

Trend analysis

Control charts

MS Office

LIMS

Education

Bachelor's degree

Master's degree

Tools

LIMS

Job description

SAB BIO is seeking an Analytical Development Supervisor in the ADQC department to drive day-to-day lab performance, ensuring cGMP, regulatory compliance and data integrity. You will lead method development, transfer to internal/external labs, lifecycle management, and readiness for CMC milestones and regulatory submissions.

Relocation assistance is available. The role focuses on biologics programs from early phase to pivotal phase and commercialization, with collaboration across QA/QC and