Description

At Viridian Therapeutics, 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 Director of Analytical Development, the Senior Manager, Analytical Development is responsible for the management of analytical studies to advance drug substance and drug product through development and pre-commercialization. The incumbent will work collaboratively with internal stakeholders to ensure accurate tracking, analysis and reporting of all analytical activities.  

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):

• Manage CRO/CMO for analytical activities supporting drug substance and (or) product including: method transfer, method development, method validation, supporting investigations and design of development studies
• Provide detailed review and approval of analytical methods, development reports, validation protocol and reports, stability protocols and reports, certificate of testing, raw data etc.
• Interpret and present data to cross functional teams to support data-driven decisions
• Manage and provide technical guidance to support investigations, quality events and development studies at CDMO/CROs
• Support analytical change controls, investigations and deviations
• Assist in the preparation of regulatory submissions

Requirements

• Requires a BS in Analytical Chemistry or related discipline with 7+ years of experience in pharmaceutical/ biotechnology industry or MS with 5+ years of experience in the pharmaceutical/ biotechnology industry
• Direct experience working with managing multiple third-party vendors
• Requires 3+ years of experience in external CMO management supporting analytical method development, optimization, transfer, validation, and lifecycle management activities
• Provide technical guidance for analytical methods and transferred within an external network, ensuring methods are technically sound and well developed
• Experience with high concentration large molecules and biological modalities preferred
• Broad understanding of clinical phase appropriate cGMP requirements, compendial testing, and regulatory guidance with respect to development and testing of biological therapeutics
• Strong subject matter expertise in biophysical/biochemical OR potency assays for protein therapeutics
• Strong commitment to ethical standards
• Strong oral/written communication skills. Excellent interpersonal/ organizational skills and the ability to multi-task
• Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.) and data management and statistical software (i.e., GraphPad and JMP)
• Ability to travel 10 - 20% domestic and internationally
• 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 coverage with 100% of premiums paid by Viridian for employees and their eligible dependents
• Fertility and mental health programs
• 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 mental, financial, and proactive physical health programs covered by Viridian

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.