Senior Director, Biologics Analytics & QC

Seismic Tx; Massachusetts; On-site; USD 195,000 - 300,000; Full time

Job summary

Seismic Therapeutic is seeking an analytical development and QC lead to guide analytical strategies across its biologics portfolio. You will oversee external partners (CDMOs, CROs) and ensure regulatory alignment with development programs.

You will lead method development, qualification, transfer, and lifecycle management, and provide analytical input for regulatory submissions. This role may be filled at Director or Senior Director level based on experience and scope.

Qualifications

• PhD, MS, or BS in analytical chemistry, biochemistry, chemistry, pharmaceutical sciences, chemical engineering, or related discipline with 10+ years of biotech/pharma experience.
• Experience leading analytical development for biologics (monoclonal antibodies, Fc-fusion proteins, or other engineered protein therapeutics).
• Experience directing analytical activities at CDMOs, CROs, and contract testing laboratories with oversight of budgets and timelines.

Responsibilities

• Provide analytical leadership across Seismic's biologic portfolio aligned with program milestones.
• Manage outsourced analytical workstreams at CDMOs/CROs with scope, timelines, budget, and performance management.
• Develop and lead phase-appropriate analytical lifecycle management strategy for Seismic’s pipeline of biologics.
• Lead analytical development, qualification, validation, transfer, and lifecycle management; ensure methods are fit for purpose.

Skills

Hands-on data review

Analytical development

CDMO oversight

Method qualification/validation

Regulatory support

cGMP knowledge

Education

PhD / MS / BS in analytical chemistry, biochemistry, chemistry, pharmaceutical sciences, chemical engineering

Job description

Seismic Therapeutic is seeking an analytical development and QC lead to guide analytical strategies across its biologics portfolio. You will oversee external partners (CDMOs, CROs) and ensure regulatory alignment with development programs.

You will lead method development, qualification, transfer, and lifecycle management, and provide analytical input for regulatory submissions. This role may be filled at Director or Senior Director level based on experience and scope.