Biologics Formulation & Drug Product Lead

Viridian Therapeutics, Inc.; Waltham (MA); Hybrid; USD 200,000 - 245,000; Full time

Benefits offered by this job

Competitive pay and stock options

Medical, dental, and vision insurance

Disability coverage

Life, Travel and AD&D

401(k) Company Match with immediate v

Employee Stock Purchase plan

Generous vacation plan

Job summary

Viridian Therapeutics, Inc. seeks a Director of Formulation and Drug Product Development to lead strategy across formulation and drug product development for biologics.

Based in Waltham, MA, the role requires strong leadership, deep expertise in monoclonal antibodies, and the ability to drive phase-appropriate development from early to commercial readiness.

You will mentor teams, collaborate with external CDMOs, author regulatory sections, and shape CMC strategy and program execution.

Qualifications

• Ph.D. with 8+ years in industry preferred; or
• MS with 10+ years of relevant experience; or
• BS with 12+ years of relevant industry experience
• Experience with external CDMOs and outsourced development
• Deep understanding of protein formulation science and stabilization
• Strong analytical data interpretation and experimental design
• Experience with high-concentration protein formulations and lyophilized products
• Willingness to travel up to 15%

Responsibilities

• Lead formulation development activities for biologic products across development stages
• Develop formulation strategies balancing quality, manufacturability, and timelines
• Design and interpret formulation and process development studies
• Guide product quality attributes and regulatory expectations
• Lead drug product process development, scale-up, tech transfer, and validation
• Provide leadership for external CDMOs and manufacturing partners
• Review technical documents, change controls, and development plans
• Contribute to CMC strategy and regulatory submissions

Skills

Formulation development

Protein formulation

Process development

Analytical methods

Data analysis

Team leadership

Education

Ph.D. in Pharmaceutical Sciences

MS in a related field

BS in a related field

Tools

Microsoft Office

Job description

Viridian Therapeutics, Inc. seeks a Director of Formulation and Drug Product Development to lead strategy across formulation and drug product development for biologics.

Based in Waltham, MA, the role requires strong leadership, deep expertise in monoclonal antibodies, and the ability to drive phase-appropriate development from early to commercial readiness.

You will mentor teams, collaborate with external CDMOs, author regulatory sections, and shape CMC strategy and program execution.