Associate Director, Analytical Development

At Viridian, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic candidates for well-validated targets.

Reporting to the Head of Analytical Development, the Associate Director, Analytical Development is responsible for management and execution of a range of analytical activities supporting Viridian’s development pipeline. The successful candidate will collaborate extensively with internal stakeholders and external CDMO/ CRO partners to advance Viridian’s therapeutic assets through development and commercialization.

This role is based in our Waltham, MA headquarters. Our office-based employees are required to work in the office three (3) days per week.

Responsibilities (including, but not limited to):

• Manage analytical activities at partner CDMOs/CROs to support drug substance/product testing, method transfer/troubleshooting/validation and supporting investigations and development studies.
• Develop and implement platforms to support statistical analysis, trending and modeling of batch, stability and characterization data to enhance product knowledge.
• Provide detailed review and approval of analytical methods, development reports, validation protocol and reports, stability protocol, etc.
• Provide technical and logistical support for execution of analytical change controls, risk assessments, root cause investigations, deviations, etc.
• Author and review technical reports, technical data packages and relevant CMC sections for regulatory filings (INDs, IMPDs, NDAs, MAAs, etc.)

Qualifications:

• Master’s degree in biochemistry, analytical chemistry or related field with 10 years of experience or PhD with 6 years of experience in analytical development/sciences, with demonstrated experience in CDMO management/oversight.
• Demonstrated hands-on experience and Subject Matter Expertise in biophysical and/or potency testing of protein therapeutics is required. Experience with monoclonal antibodies and high-concentration formulations is preferred.
• Deep knowledge of statistical approaches and methodologies for CMC applications, including proficiency with software for tracking, trending, and comparability analyses (e.g., JMP, GraphPad, Minitab, etc.).
• Experience with execution and/or oversight of analytical method development, troubleshooting, transfer and validation.
• Familiarity with cGMP, ICH, FDA, and EU guidelines.
• Direct experience authoring of analytical, stability and comparability sections of regulatory documents. Experience with BLA and MAA preparation is preferred.
• Excellent communication and collaboration skills; ability to work independently and in cross-functional teams.
• Strong commitment to ethical standards
• Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
• 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
• Competitive 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

Viridian Therapeutics, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination, harassment, or retaliation of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by Federal, State, and Local laws. Viridian will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Viridian Therapeutics, Inc participates in E-Verify, the federal program for electronic verification of employment eligibility.