Head of Biologics Analytics & Quality Control Strategy

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

Benefits offered by this job

Equity compensation

Annual bonus

Benefits program

Equal Opportunity Employer

Job summary

Korsana Biosciences seeks a Senior Director to lead Biologics Analytical Development and Quality Control for a pipeline spanning preclinical to clinical programs. You will direct analytical method development, qualification, validation, and testing through outsourced partners, ensuring quality, timelines, and budgets are met.

Successful candidates will have 12+ years of biologics analytical experience, strong CMC/regulatory knowledge, and a strategic yet hands-on leadership style.

Qualifications

• Ph.D. in (bio)chemistry or related field, or MS/BS with equivalent education or experience.
• At least 12 years of hands-on biologics analytical development in biotech or biopharma.
• Experience leading outsourced analytical development with CDMOs and contract labs.
• Proven track record with IND/IMPD/CTA submissions.

Responsibilities

• Develop and implement CMC strategies for analytical development and testing.
• Oversee outsourcing and vendor management with CDMOs and contract labs.
• Define specifications and document rationales for materials and products.
• Monitor in-process, release, and stability data; manage CAPAs and investigations.
• Prepare CMC documentation for regulatory filings and patents.
• Lead regulatory submissions and ensure timely delivery and alignment with budgets.
• Communicate progress to senior management and cross-functional teams.

Skills

Analytical development leadership

Quality control oversight

CDMO/external partner management

Regulatory knowledge (CMC/IND/IMPD/CTA

Strategic planning

Education

Ph.D. in biochemistry or related

MS/BS with equivalent experience

Job description

Korsana Biosciences seeks a Senior Director to lead Biologics Analytical Development and Quality Control for a pipeline spanning preclinical to clinical programs. You will direct analytical method development, qualification, validation, and testing through outsourced partners, ensuring quality, timelines, and budgets are met.

Successful candidates will have 12+ years of biologics analytical experience, strong CMC/regulatory knowledge, and a strategic yet hands-on leadership style.