Senior Analytical Development Lead (Biologics)

SAB; Sioux Falls, Northern (SD, KY); Hybrid; USD 120,000 - 160,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

SAB BIO is seeking an Analytical Development Supervisor to lead hands-on analytics in the ADQC lab, from method development through transfer to internal and external labs. You will ensure cGMP compliance and drive data integrity for biologics programs. The role supports regulatory submissions and lifecycle management of analytical methods.

Relocation assistance is available. The position requires strong technical writing, data analysis, and collaboration with QA/QC teams to ensure inspection

Qualifications

• Bachelor's degree with 7+ years of relevant experience in biotech/pharma.
• Experience with bioanalytical methods and regulatory guidelines (ICH, FDA).
• Experience with reference standard programs and forced degradation studies.
• Experience presenting technical data in group settings.

Responsibilities

• Lead hands-on analytical work including method development, qualification, validation, transfer, and documentation.
• Ensure readiness for late-stage development, PPQ, and commercial launch related to SAB-142 program.
• Lead troubleshooting, method improvement, investigations, CAPA, and change control activities.
• Participate in qualification and stability monitoring of references standards and critical reagents.
• Ensure analytical activities comply with cGMP, ICH, USP/EP, and global regulations.
• Support specification setting and regulatory submissions.
• Manage lab operations, equipment qualification, and use of LIMS.
• Collaborate with Quality Control/Assurance to maintain GMP compliance and inspection readiness.

Skills

Method development

Validation

Data analysis

Technical writing

Communication

Troubleshooting

Quality systems

LIMS workflows

Education

Bachelor's degree in life sciences

7+ years in biotech/pharma

Master’s degree desired

Tools

HPLC

A280

CE-SDS

cIEF

LC-MS

ELISA

Office software (Word/Excel/PowerPoint)

LIMS

Job description

SAB BIO is seeking an Analytical Development Supervisor to lead hands-on analytics in the ADQC lab, from method development through transfer to internal and external labs. You will ensure cGMP compliance and drive data integrity for biologics programs. The role supports regulatory submissions and lifecycle management of analytical methods.

Relocation assistance is available. The position requires strong technical writing, data analysis, and collaboration with QA/QC teams to ensure inspection