Master's degree with 8+ years or Bachelor's degree with 10+ years in biopharmaceutical quality control or analytical development
Experience with QC analytical method lifecycle activities for biologics
Familiarity with contract laboratories and external manufacturing partners
Experience supporting regulatory inspections and health authority interactions
Strong technical knowledge of analytical methods including ELISA and chromatography
Proficiency with data analysis tools and statistical methods
Strong written and verbal communication skills
Responsibilities
Provide strategic leadership to the QC Analytical team and external partners
Develop phase-appropriate specifications and reference standards
Analyze and communicate complex analytical data to stakeholders
Establish priorities and ensure timely delivery of QC commitments
Lead method lifecycle management for QC owned methods
Provide leadership for external CMOs and CTLs in analytical testing
Identify and escalate analytical or compliance risks early
Benefits
Competitive pay and stock options
Medical, dental, and vision insurance
100% Paid Parental Leave
Short- and long-term disability coverage
Life, Travel and AD&D insurance
401(k) Company Match with immediate vesting
Employee Stock Purchase plan
Generous vacation plan and paid company holiday shutdowns
Various fertility, mental, financial, and proactive physical health programs
Full Job Description
Description
Reporting to the Director, Quality Control Analytical, the Associate Director, Quality Control will primarily manage Viridian's stability program performed by outside testing laboratories. The Associate Director will manage CMO/CTL, review data and prepare CoA. This position works closely with other functions within Viridian and external CMO/CTLs.
This role is based in our Waltham, MA headquarters. Our office-based employees are required to work in the office three (3) days a week.
Responsibilities (including, but not limited to):
Provide strategic leadership to the QC Analytical team, including oversight of external partners to support all stages of program development
Develop and evolve phase-appropriate specifications, reference standards, and critical reagents in accordance with global regulatory requirements
Analyze and communicate complex analytical data to internal stakeholders, senior leadership, and external partners
Establish priorities, lead cross-functional activities, and ensure timely delivery of QC commitments through effective influence and collaboration
Lead method lifecycle management for QC owned methods including transfers, validations, performance monitoring, improvements and change impact assessments
Provide strategic and operational leadership for external CMOs and CTLs supporting analytical testing, stability, and product release activities for clinical-stage biopharmaceutical and combination products, including accountability for performance, quality, timelines, issue resolution, and escalation
Align technical expectations across internal teams and external partners, review data and deliverables, resolve issues, and drive partner accountability
Identify and escalate analytical, compliance, or execution risks early, with a recommended path forward
Lead or support deviation, OOS/OOT investigations, and implement robust root cause analysis and corrective actions
Contribute to CMC regulatory submissions, including IND, BLA, and global filings and regulatory inquiries. Support inspection readiness activities and vendor audits
Serve as the QC subject matter expert during inspections and regulatory inquiries
Partner with Quality Assurance, Regulatory Affairs, Manufacturing, and Technical Development to ensure alignment across the product lifecycle
Requirements
Requires a Master's degree with 8+ years of relevant experience or a Bachelor's degree with 10+ years of experience in biopharmaceutical quality control or analytical development.
Demonstrated experience with QC analytical method lifecycle activities for biologics, including method transfer, validation, performance monitoring, improvement, and expansion to support EU regulatory and market requirements
Experience working with contract laboratories and external manufacturing partners, including data review, technical issue resolution, and partner oversight
Experience supporting regulatory inspections and health authority interactions
Strong technical knowledge of analytical, bioanalytical, and device test methods used for biopharmaceutical and combination products, including ELISA, chromatography (HPLC/UPLC), electrophoresis, spectroscopy, compendial methods, and device functional performance testing
Experience leading investigations and quality system processes (deviations, OOS, CAPA, change control)
Proficiency with data analysis tools and statistical methods (e.g., JMP) supporting specification setting and method performance trending and data integrity expectations in regulated environments
Ability to operate effectively in a dynamic, fast-paced biotechnology environment
Strong written and verbal communication skills with experience preparing technical and regulatory documentation
Strong commitment to ethical standards
Proficiency with Microsoft Office Suite (Word, PowerPoint, Excel, Outlook, SharePoint)
Ability to travel up to 10%
The salary range for this position is commensurate with experience
Viridian offers a comprehensive benefits package including:
Competitive pay and stock options for all employees
Medical, dental, and vision insurance
100% Paid Parental Leave
Short- and long-term disability coverage
Life, Travel and AD&D
401(k) Company Match with immediate company vest
Employee Stock Purchase plan
Generous vacation plan and paid company holiday shutdowns
Various fertility, mental, financial, and proactive physical health programs
About Viridian Therapeutics
Viridian Therapeutics is a biotechnology company that develops gene therapies for inherited diseases. The company's lead product candidate, VRDN-001, is a gene therapy for Friedreich's ataxia, a rare genetic disease that causes progressive damage to the nervous system. Viridian Therapeutics was founded in 2018 and is headquartered in Cambridge, Massachusetts.
