Senior Director, Biologics Analytical Development & QC

Seismic Therapeutic; Watertown (MA); Presencial; USD 195.000 - 300.000; Jornada completa

Descripción de la vacante

Seismic Therapeutic in Watertown, Massachusetts seeks an analytical development and QC lead to guide analytical strategies across biologics programs, including oversight of CDMOs, CROs, and contract labs within Seismic's externalized operating model.

The role covers product characterization, control strategies, method development, validation, transfer, release, stability studies, and regulatory submission support within the CMC team, with potential for Director or Senior Director level based on

Formación

• PhD/MS/BS with 10+ years in biotech/pharma analytical development.
• Expertise in monoclonal antibodies and Fc-fusion proteins.
• Experience directing analytics at CDMOs/CROs.
• Strong knowledge of cGMP and regulatory expectations for biologics.
• Hands-on data review and problem-solving in lean teams.

Responsabilidades

• Provide analytical leadership across Seismic's biologic portfolio.
• Manage outsourced analytical workstreams (CDMOs/CROs/labs).
• Define analytical control strategies and attributes.
• Lead method qualification/validation/transfer and lifecycle management.
• Author analytical sections of CMC regulatory submissions.

Conocimientos

Analytical leadership

CDMOs oversight

Regulatory submissions

Biologics analytics

Team leadership

Educación

PhD/MS/BS in analytical chemistry/biochemistry/related

Herramientas

Chromatographic assays

Mass spectrometry

Biophysical assays

Cell-based potency assays

Descripción del empleo

Seismic Therapeutic in Watertown, Massachusetts seeks an analytical development and QC lead to guide analytical strategies across biologics programs, including oversight of CDMOs, CROs, and contract labs within Seismic's externalized operating model.

The role covers product characterization, control strategies, method development, validation, transfer, release, stability studies, and regulatory submission support within the CMC team, with potential for Director or Senior Director level based on