Senior Director, Biologics Analytics & QC

Seismic Therapeutic Inc; Watertown (MA); Vor Ort; USD 195.000 - 300.000; Vollzeit

Zusammenfassung

Seismic Therapeutic Inc. in Watertown, MA seeks a Director/Senior Director of Analytical Development and QC to lead strategies across biologics, oversee external labs, and drive CMC regulatory submissions.

You will mentor a hands-on team and partner with Quality and CDMOs to ensure robust analytical lifecycle management. This role requires deep experience in monoclonal antibodies and Fc‑fusion proteins, strong leadership, and a track record of delivering data-driven decisions in a lean

Qualifikationen

• PhD, MS, or BS in analytical science with 10+ years in biotech/pharma analytical development.
• Proven experience leading analytical development for biologics like antibodies.
• Experience directing activities at CDMOs/CROs with budget/Timeline ownership.

Aufgaben

• Lead analytical strategies across biologics programs and regulatory needs.
• Oversee outsourcing to CDMOs/CROs and manage performance within timelines.
• Define analytical control strategies, attributes, and specifications.
• Prepare analytical sections of CMC regulatory submissions.

Kenntnisse

Hands-on data review

Analytical leadership

Strategic thinking

Ausbildung

Analytical chemistry / Biochemistry degree

Tools

Chromatography

Mass spectrometry

Biophysical assays

Binding assays

Cell-based potency assays

Jobbeschreibung

Seismic Therapeutic Inc. in Watertown, MA seeks a Director/Senior Director of Analytical Development and QC to lead strategies across biologics, oversee external labs, and drive CMC regulatory submissions.

You will mentor a hands-on team and partner with Quality and CDMOs to ensure robust analytical lifecycle management. This role requires deep experience in monoclonal antibodies and Fc‑fusion proteins, strong leadership, and a track record of delivering data-driven decisions in a lean