Biologics Drug Substance Leader: Development & Manufacturing

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

Benefits offered by this job

Target annual bonus

Equity-based compensation

Participation in benefit programs

Job summary

Korsana Biosciences, Inc. is seeking a Senior Director, Biologics Drug Substance Development and Manufacturing to lead DS development and outsourced manufacturing for a portfolio of preclinical and clinical programs. You will define project scope, mitigate risks, and ensure timely, quality delivery with external partners.

The role requires strategic vision and hands-on experience in managing early biotech programs, CDMO selection, regulatory submissions, and cross-functional collaboration.

Qualifications

• PhD or MSc/BS with equivalent experience in relevant life sciences.
• At least 12 years in biologics drug substance development in biotech/pharma.
• Experience with IND/IMPD and fast-paced startup environments.

Responsibilities

• Establish CMC strategies for biologics DS development, scale-up, and GMP manufacturing.
• Collaborate with internal teams and external partners to push projects forward.
• Create metrics, monitor results, and manage risk to meet goals and budget.
• Support deviations, CAPAs, and stability testing with QA.
• Lead CDMO/CRO selection, negotiations, and budgeting.
• Maintain current knowledge of biologics DS manufacturing technologies.
• Communicate progress to management and ensure clear records.

Skills

Biologics DS development

CDMO selection & management

Regulatory submissions (CMC)

Strategic & hands-on leadership

Cross-functional collaboration

Program management

Education

Ph.D. in (bio)chemistry or (bio)chemical engineering, or MS/BS with experience

Job description

Korsana Biosciences, Inc. is seeking a Senior Director, Biologics Drug Substance Development and Manufacturing to lead DS development and outsourced manufacturing for a portfolio of preclinical and clinical programs. You will define project scope, mitigate risks, and ensure timely, quality delivery with external partners.

The role requires strategic vision and hands-on experience in managing early biotech programs, CDMO selection, regulatory submissions, and cross-functional collaboration.