Senior Biologics Analytical Development Lead

SAB BIO; Sioux Falls (SD); On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

SAB BIO is seeking an Analytical Development Supervisor within the ADQC department to drive day-to-day lab performance in a highly regulated environment. You will lead method development, qualification, validation, and transfers to internal and external QC labs while ensuring readiness for regulatory submissions.

The role requires hands-on expertise in A280, HPLC, CE-SDS, cIEF, LC-MS, and adherence to cGMP standards.

Qualifications

• Bachelor's degree with 7+ years in life sciences or biotech
• Hands-on expertise in A280, HPLC, CE-SDS, cIEF, LC-MS
• Strong knowledge of method validation, transfer, and cGMP
• Excellent communication and cross-functional collaboration skills
• Experience with reference standard programs and forced degradation studies

Responsibilities

• Lead and perform hands-on analytical work including method development, qualification, validation, transfer to internal and external QC labs, lifecycle management, and documentation
• Ensure analytical readiness for late-stage development, PPQ, and commercial launch of SAB-142 polyclonal antibody program
• Lead troubleshooting and optimization, investigations, CAPA, change control, and continuous method improvement
• Support qualification and stability monitoring of reference standards and reagents; run extended characterization assays and forced degradation studies
• Ensure compliance with cGMP, ICH, USP/EP, and QbD; align with quality standards and regulatory readiness
• Coordinate with Quality Control/Quality Assurance and external partners to maintain analytical documentation and data integrity
• Contribute to specification setting and regulatory submissions
• Oversee lab operations, equipment qualification, and implementation of LIMS workflows

Skills

A280

HPLC

CE-SDS

cIEF

LC-MS

ELISA

Cell-based potency

Method validation

Method transfer

cGMP

MS Office

Education

Bachelor's degree in life sciences

Master's degree

Tools

LIMS

Job description

SAB BIO is seeking an Analytical Development Supervisor within the ADQC department to drive day-to-day lab performance in a highly regulated environment. You will lead method development, qualification, validation, and transfers to internal and external QC labs while ensuring readiness for regulatory submissions.

The role requires hands-on expertise in A280, HPLC, CE-SDS, cIEF, LC-MS, and adherence to cGMP standards.