Analytical Development Scientist, Biologics (Relocation)

SAB; Sioux Falls (SD); Vor Ort; USD 110.000 - 170.000; Vollzeit

Benefits dieser Stelle

Relocation assistance

Zusammenfassung

SAB is seeking an experienced Scientist, Analytical Development to drive hands-on analytical work in our ADQC laboratory. You will lead method development, validation, transfer, and lifecycle management for biologics programs, ensuring readiness for regulatory submissions and commercialization.

You will work closely with Quality Control and Quality Assurance to maintain analytical quality and inspection readiness, while mentoring junior staff as the group expands.

Qualifikationen

• Bachelor's degree with 7+ years of progressively responsible and relevant experience in life sciences, Biophysics, Biochemistry or a related discipline in a biotech/pharma environment.
• Master’s degree highly desirable.
• Deep hands-on expertise in analytical techniques (A280, HPLC, CE-SDS, cIEF, LC-MS).
• Experience in ELISA and cell-based potency methods is a plus.
• Strong understanding of method validation, transfer, and cGMP regulations.
• Experience with reference standards, critical reagents programs, and forced degradation studies.
• Proficient in data analysis and presentation; skilled in MS Office tools.

Aufgaben

• Lead and perform hands-on analytical work including method development, qualification, validation, transfer to internal and external QC labs, lifecycle management, and documentation (reports, reports, SOPs).
• Ensure analytical readiness for late-stage development, PPQ, and commercial launch.
• Lead troubleshooting, optimization, bridging, performance monitoring, investigations, CAPA, change control, and continuous improvement; author documentation.
• Contribute to qualification and stability monitoring of reference standards and reagents; perform forced degradation studies.
• Ensure analytical activities comply with cGMP, ICH, USP, global regulations and QbD principles; align with quality standards.
• Contribute to specification setting and regulatory submissions.
• Manage lab operations, equipment qualification/maintenance, and establish analytical workflows and LIMS.
• Collaborate with QC/QA to ensure analytical quality and inspection readiness.
• Perform other duties as assigned.

Kenntnisse

A280

HPLC

CE-SDS

cIEF

LC-MS

ELISA

Cell-based potency

Ausbildung

Bachelor's degree with 7+ years of experience in life sciences (Biophysics/Biochemistry)

Master’s degree desirable

Tools

Microsoft Office (Word, Excel, PowerPoint, Outlook)

Jobbeschreibung

SAB is seeking an experienced Scientist, Analytical Development to drive hands-on analytical work in our ADQC laboratory. You will lead method development, validation, transfer, and lifecycle management for biologics programs, ensuring readiness for regulatory submissions and commercialization.

You will work closely with Quality Control and Quality Assurance to maintain analytical quality and inspection readiness, while mentoring junior staff as the group expands.