Senior Analytical Development Scientist - Bioassays

SAB BIO; Sioux Falls (SD); On-site; USD 90,000 - 130,000; Full time

Job summary

SAB BIO is seeking a Senior Research Associate 2 Analytical Development to execute analytical development activities for bioassays and potency assays across biologics programs from early phase to regulatory submissions.

You will have high autonomy in method development, qualification, transfer to internal and external labs, and ensure readiness to meet CMC milestones and regulatory submissions in a fast-paced, regulated environment.

Qualifications

• Bachelor's degree with 8+ years of experience or master's degree with 4+ years of experience in life sciences or related discipline.
• Deep hands-on expertise in various bioassays and potency assays including ELISA, cell-based potency methods, and flow cytometry for biologics.
• Experience with other ligand binding assays such as MSD, Biacore or Octet preferred but not required; microbial assays and plasma/serum samples desired.
• Strong understanding of method validation, transfer, and applicable guidelines (ICH, FDA guidance, USP/EP) with deep cGMP knowledge.
• Experience with critical reagent qualification and stability monitoring for bioassays and potency assays.
• Proficiency in data analysis using simple statistics and trend analysis; strong written and verbal communication.
• Demonstrated proficiency in Microsoft Office applications (Word, Excel, PowerPoint).

Responsibilities

• Lead hands-on analytical work for bioassays and potency assays including development, qualification, validation, and transfer to QC labs.
• Ensure analytical readiness for late-stage development, PPQ, and commercial launch of SAB-142 program.
• Lead troubleshooting, optimization, investigations (deviations, OOS), CAPA, change control, and documentation.
• Support reference standard and critical reagent qualification, and testing of extended characterization bioassays.
• Ensure activities meet cGMP, ICH, USP/EP guidelines and align with quality standards.
• Support specification setting and regulatory submissions.
• Manage general lab operations including ordering supplies and equipment qualification.
• Support establishment of analytical non-GMP development area and LIMS implementation.
• Collaborate with Quality Control and Quality Assurance for GMP compliance and inspection readiness.
• Other duties as assigned.

Skills

bioassays

potency assays

ELISA

cell-based potency methods

flow cytometry

MSD

Biacore

Octet

method validation

cGMP compliance

data analysis

statistics

technical writing

Microsoft Office

Education

Bachelor's degree in life sciences

Master's degree in life sciences

Tools

MSD

Biacore

Octet

Job description

SAB BIO is seeking a Senior Research Associate 2 Analytical Development to execute analytical development activities for bioassays and potency assays across biologics programs from early phase to regulatory submissions.

You will have high autonomy in method development, qualification, transfer to internal and external labs, and ensure readiness to meet CMC milestones and regulatory submissions in a fast-paced, regulated environment.