Director, QC Analytical & Method Excellence

Viridian Therapeutics, Inc.; Waltham (MA); On-site; USD 170,000 - 210,000; Full time

Benefits offered by this job

Competitive pay and stock options

Medical, dental, vision insurance

Disability coverage

401(k) Company Match with vesting

Employee Stock Purchase plan

Generous vacation and holidays

Job summary

Viridian Therapeutics, Inc. seeks a Director of QC Analytical in Waltham, MA to lead the QC Analytical team and oversee external partners, ensuring high-quality analytical support across development programs.

The role collaborates with CMC, Analytical Development, and Process Development to drive method transfers, validations, and lifecycle improvements, while ensuring compliance with cGMP and global regulations. Office-based with 3 days on-site per week.

Qualifications

• BS, MS or PhD in a life science discipline with 12+ years of relevant industry experience.
• Strong background in analytical methods and data analysis, including compendial methods.
• Demonstrated leadership experience in QC operations and oversight of external CMOs/CTLs.
• Deep knowledge of cGMP, ICH, FDA, and EU regulations and guidance.
• Proven hands-on experience with analytical methods including SEC, icIEF, CE-SDS, Peptide mapping, Potency and compendial methods as well as functional device testing.
• Strong people leadership skills, with experience coaching, developing, and managing staff at various levels.
• Comfortable in an adaptable small company environment with minimal direction and able to adjust workload based upon changing priorities.
• Strong commitment to ethical standards.
• Proficient with Microsoft Office suite (Word, PowerPoint, Excel, Outlook, SharePoint, etc.).
• Ability to travel up to 5%.

Responsibilities

• Provide strategic leadership to the QC Analytical team, including oversight of external partners to support all stages of program development.
• Collaborate with CMC functions, including Analytical Development and Process Development, to ensure aligned QC support.
• Lead method lifecycle management for QC owned methods including transfers, validations, performance monitoring, and improvements.
• Provide strategic oversight for late phase reference standard implementation and ongoing lifecycle management.
• Provide oversight of specifications throughout product lifecycle.
• Analyze and present data, present to both internal and external stakeholders.
• Ensure QC deliverables are met and provide leadership/professional development for team.
• Oversee external partners (CMOs, CTLs) to ensure adherence to quality and regulatory expectations.
• Support regulatory submissions by authoring and reviewing relevant CMC sections.
• Prepare QC personnel for inspection readiness, support vendor audits, and serve as the QC SME during inspections.
• Oversee quality records within assigned areas, including OOS/OOT investigations and related deliverables.

Skills

Leadership

QC operations

Data analysis

Analytical methods

Regulatory compliance

cGMP

CMO/CTL oversight

Communication

Travel readiness

Education

BS/MS/PhD in life sciences

Tools

SEC

icIEF

CE-SDS

Peptide mapping

Potency assays

Job description

Viridian Therapeutics, Inc. seeks a Director of QC Analytical in Waltham, MA to lead the QC Analytical team and oversee external partners, ensuring high-quality analytical support across development programs.

The role collaborates with CMC, Analytical Development, and Process Development to drive method transfers, validations, and lifecycle improvements, while ensuring compliance with cGMP and global regulations. Office-based with 3 days on-site per week.