Senior Manager, Quality Control

Scorpion Therapeutics; San Francisco (CA); Hybrid; USD 180,000 - 230,000; Full time

Benefits offered by this job

Hybrid work (3 days onsite)

Job summary

Scorpion Therapeutics in San Francisco is seeking a Senior Manager, Technical Operations Quality Control to execute and operationalize the QC strategy across early to commercial biologics programs, including monoclonal antibodies.

You will oversee release and stability testing, method lifecycle management, and vendor oversight of external laboratories, while ensuring strict cGMP/ICH/FDA compliance and readiness for development to commercialization.

Qualifications

• BA/BS with 10+ years or MA/MS with 8+ years in Biochemistry, Chemistry, Biology, or related.
• Strong expertise in analytical methods for biologics, validation, transfer, and cGMP compliance.

Responsibilities

• Oversee QC activities such as release and stability testing, method lifecycle management, and vendor oversight of external laboratories.
• Support development and refinement of QC strategies.
• Ensure compliance with cGMP/ICH/FDA regulations.
• Manage risk mitigation, program readiness, and external partner performance.
• Coordinate QC documentation, sampling, and testing logistics.

Skills

Analytical methods

cGMP compliance

Validation & transfer

Regulatory compliance

Education

BS in Biochemistry/Chemistry/Biology

Job description

Role:

Senior Manager, Technical Operations Quality Control, responsible for executing and operationalizing the QC strategy across early to commercial phases for biopharmaceutical programs, including monoclonal antibodies.

Responsibilities:

• oversee QC activities such as release and stability testing, method lifecycle management, and vendor oversight of external laboratories
• support development and refinement of QC strategies
• ensure compliance with cGMP/ICH/FDA regulations
• manage risk mitigation, program readiness, and external partner performance
• coordinate QC documentation, sampling, and testing logistics

Qualifications:

• BA/BS with 10+ years or MA/MS with 8+ years in Biochemistry, Chemistry, Biology, or related
• strong expertise in analytical methods for biologics, validation, transfer, and cGMP compliance

HighValue:

• biologics (monoclonal antibodies)
• QC strategy development
• external testing oversight
• clinical to commercial lifecycle
• regulatory compliance

WorkSetup:

based in San Francisco, hybrid (3 days onsite).