Analytical Development Supervisor

Scorpion Therapeutics; Sioux Falls (SD); On-site; USD 110,000 - 160,000; Full time

Job summary

Scorpion Therapeutics seeks an Analytical Development Supervisor in the ADQC lab to lead biologics analytics from early to late development, supporting regulatory submissions and commercialization.

You will oversee method development, qualification, validation, and lifecycle management, ensuring readiness for late-stage programs and market launch, while maintaining GMP-compliant standards and coordinating with QC/QA and external partners.

Qualifications

• Bachelor's degree with 7+ years in life sciences/biotech/pharma.
• Deep expertise in HPLC, CE-SDS, cIEF, LC-MS and method validation per ICH/FDA/USP/EP guidelines.
• Strong scientific judgment, technical writing and communication skills.

Responsibilities

• Lead hands-on analytical activities including method development, qualification, validation, transfer, troubleshooting, and lifecycle management.
• Ensure analytical readiness for late-stage development and market launch.
• Oversee reference standards, assay controls, and critical reagents.
• Contribute to specification setting and regulatory documentation.
• Manage lab operations, equipment, and infrastructure.
• Collaborate with QC, QA, and external partners to maintain GMP compliance and inspection readiness.

Skills

HPLC

LC-MS

CE-SDS

cIEF

Method validation

Education

Bachelor's degree in life sciences

Job description

Role

Analytical Development Supervisor within the ADQC lab, focusing on biologics (polyclonal antibody) development from early to late stages, supporting regulatory submissions and commercialization.

Responsibilities

• lead hands-on analytical activities including method development, qualification, validation, transfer, troubleshooting, and lifecycle management
• ensure analytical readiness for late-stage development and market launch
• oversee reference standards, assay controls, and critical reagents
• contribute to specification setting and regulatory documentation
• manage lab operations, equipment, and infrastructure
• collaborate with QC, QA, and external partners to maintain GMP compliance and inspection readiness

Qualifications

Bachelor's degree with 7+ years in life sciences/biotech/pharma, deep expertise in HPLC, CE-SDS, cIEF, LC-MS, and experience with method validation per ICH, FDA, USP/EP guidelines; strong scientific judgment, technical writing, and communication skills.

Preferred

Master’s degree, experience in reference standard programs, statistical trend analysis, and working knowledge of GMP, QbD, and regulatory requirements.

High-Value

biologics, polyclonal antibodies, cGMP, late-phase development, regulatory submissions, external CDMO partnerships.

Work setup

laboratory-based, no travel expected; potential supervision of junior staff as team expands.