Biologics Formulation & Drug Product Lead

Viridian Therapeutics, Inc.; Waltham (MA); On-site; USD 170,000 - 230,000; Full time

Benefits offered by this job

Competitive pay

Stock options

Medical, dental, and vision insurance

401(k) company match

Employee stock purchase plan

Job summary

Viridian Therapeutics, Inc. seeks a Director of Formulation and Drug Product Development to lead biologics formulation and product development from early development to commercialization. Based in Waltham, MA, the role emphasizes cross-functional leadership, regulatory readiness, and collaboration with CDMOs and manufacturing partners.

Requires strong scientific acumen and strategic thinking. The role includes designing strategies, overseeing process development, and contributing to regulatory

Qualifications

• Ph.D. in Pharmaceutical Sciences or related field with 8+ years of industry experience preferred; or
• MS with 10+ years of industry experience; or BS with 12+ years of industry experience
• Experience supporting products from early development through late-stage development and commercial readiness
• Experience working with external CDMOs and managing outsourced development
• Deep understanding of protein formulation science, including degradation pathways and stabilization
• Strong analytical characterization to guide decisions
• Experience with high-concentration protein formulations and biologics
• Ability to travel up to 15%

Responsibilities

• Lead formulation development activities for biologic products, including design and stability strategy
• Develop formulation and drug product development strategies balancing quality and timelines
• Design and interpret formulation development, process development, and validation studies
• Apply protein science knowledge to guide development decisions
• Use analytical data to investigate stability trends and mitigation strategies
• Lead drug product process development including fill-finish and tech transfer
• Provide technical leadership for CDMOs and manufacturing partners
• Review protocols, reports, and development plans
• Contribute to CMC strategy and regulatory submissions
• Keep abreast of industry trends and regulatory expectations

Skills

Communication skills

Leadership

Autonomy

Travel up to 15%

Analytical mindset

Education

Ph.D. in Pharmaceutical Sciences or related field

M.S. in related field with 10+ years experience

B.S. with 12+ years experience

Tools

Microsoft Office

Job description

Viridian Therapeutics, Inc. seeks a Director of Formulation and Drug Product Development to lead biologics formulation and product development from early development to commercialization. Based in Waltham, MA, the role emphasizes cross-functional leadership, regulatory readiness, and collaboration with CDMOs and manufacturing partners.

Requires strong scientific acumen and strategic thinking. The role includes designing strategies, overseeing process development, and contributing to regulatory