Senior Director, Biologics Analytical Development

Automatic Data Processing, Inc.; Watertown (MA); Sur place; USD 195 000 - 300 000; Plein temps

Résumé du poste

Seismic Therapeutic is seeking an Analytical Development and QC lead to drive analytical strategies across biologics programs. You will oversee external partners (CDMOs/CROs) and ensure regulatory alignment through lifecycle management, method development, qualification, transfer, and support for submissions.

The role requires deep expertise in biologics analytics, phase-appropriate strategy, and collaboration with CMC teams to ensure product quality and regulatory readiness for clinical

Qualifications

• Willingness to roll up your sleeves and take a hands-on approach to data review and issue resolution.
• PhD, MS, or BS in analytical chemistry, biochemistry, chemistry, pharmaceutical sciences, chemical engineering, or related discipline with 10+ years in biotech/pharma analytical development.
• Expertise in analytical development of biologics (mAbs, Fc-fusion) and understanding of QC/CMC relationship.

Responsabilités

• Provide analytical leadership across Seismic's biologic portfolio and align with program milestones.
• Manage outsourced analytical workstreams at CDMOs/CROs, including scope, timelines, and budget.
• Define and implement analytical control strategies and specifications for biologics.
• Lead method qualification, validation, transfer, and comparability assessments.
• Author analytical sections of CMC regulatory submissions and support health authority questions.

Connaissances

Analytical development

CDMOs management

Regulatory submissions

Biologics expertise

Leadership

Formation

PhD/MS/BS in analytical sciences

Outils

Chromatography

Mass spectrometry

Bioassays

Description du poste

Seismic Therapeutic is seeking an Analytical Development and QC lead to drive analytical strategies across biologics programs. You will oversee external partners (CDMOs/CROs) and ensure regulatory alignment through lifecycle management, method development, qualification, transfer, and support for submissions.

The role requires deep expertise in biologics analytics, phase-appropriate strategy, and collaboration with CMC teams to ensure product quality and regulatory readiness for clinical