Biologics Analytics & Quality Strategy Director

Korsana Biosciences, Inc.; Boston (MA); On-site; USD 250,000 - 280,000; Full time

Job summary

Korsana Biosciences, Inc. is seeking a Senior Director of Biologics Analytical Development and Quality Control to lead analytical development, QC activities, and external collaboration with CDMOs.

The role requires strategic leadership and hands-on management of early-stage programs in a dynamic biotech environment. The position emphasizes CMC strategy, regulatory submissions (IND/IMPD/CTA), and ensuring data quality for preclinical and clinical programs, with a base salary in the range of

Qualifications

• Ph.D. in chemistry/biochemistry or related field or MS/BS with equivalent experience.
• ≥12 years' hands-on biologics analytical development experience.
• Experience in fast-paced startup environments preferred.
• Experience with IND/IMPD/CTA submissions and approvals.

Responsibilities

• Establish CMC strategies for analytical development and testing.
• Collaborate with internal and external partners to push projects forward.
• Recommend specifications and document rationale.
• Monitor in-process, release, stability, OOT/OOS results.
• Support deviation and OOS investigations and CAPAs.
• Prepare CMC documentation for regulatory filings.
• Lead CDMO/CRO selection, negotiations, budget/scope.
• Stay current with biologics analytical technologies.
• Set goals to ensure timely, high-quality results.
• Provide progress updates to management.
• Ensure organized records.

Skills

Biologics analytics leadership

CMC regulatory knowledge

Analytical method development

Quality control

Outsourced/CDMO management

Regulatory submissions

Education

PhD in chemistry/biochemistry/biochemical engineering

Job description

Korsana Biosciences, Inc. is seeking a Senior Director of Biologics Analytical Development and Quality Control to lead analytical development, QC activities, and external collaboration with CDMOs.

The role requires strategic leadership and hands-on management of early-stage programs in a dynamic biotech environment. The position emphasizes CMC strategy, regulatory submissions (IND/IMPD/CTA), and ensuring data quality for preclinical and clinical programs, with a base salary in the range of