Senior Director, Drug Substance Development & Commercialization

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 SVP, Technical Operations, the Senior Director, Drug Development & Commercialization is accountable for helping to set the strategic direction and operational execution plans for activities that are critical to the advancement of Viridian's pipeline drug candidates, from pre-clinical to early- and late-stage clinical to commercialization preparation and support. This person will partner with internal and external cross-functional teams to ensure operational milestones supporting regulatory submissions are met so clinical and commercial supply is uninterrupted.

This role is based in our Waltham, MA headquarters. Our office-based employees follow a hybrid in-office schedule. Remote work is allowed, and the frequency is at the discretion of management.

Responsibilities (including, but not limited to):

• Provide leadership and direction for the existing Process Development, Formulation Development, and Manufacturing Teams.

• Assist in growing the Manufacturing Sciences and Technology (MSAT) function to support Drug Substance (DS) Tech Transfers, Process Performance Qualifications, and subsequent routine commercial manufacturing.

• Ensure drug development activities align to meet the material needs of the Drug Product Development & Commercialization Team to enable a seamless plan for any finished dosage form including combination drug candidates with an autoinjector or on-body device delivery platform.

• Develop, author, review and/or approve Standard Operating Procedures, specifications, reports, regulatory filing, or other controlled documents, as needed.

• Contribute to building and maintaining a high-performing quality culture at Viridian.

• Partner with external manufacturing and the FP&A business partner to build the operational budget for all drug development activities executed at Viridian's CDMOs; ensure accuracy of accruals, invoices, purchase orders, and budget forecasting.

• Identify business risks and implement appropriate risk mitigations.

Requirements

• Bachelor's Degree in life sciences, biologic or chemical engineering or related discipline required, Master's Degree / PhD Degree a plus.

• 15+ years of experience in the Biopharmaceutical industry with a minimum of 7 years of functional leadership experience.

• Experience in the cell-line management, process and formulation development, analysis, and characterization of biologics; monoclonal antibody experience a plus as is experience across all phases of the product life cycle (early-stage development through commercialization).

• Combination drug device experience desirable.

• Working knowledge of FDA/ICH/EMA guidelines and cGMPs; familiarity with regulatory submission requirements

• Exemplary interpersonal, written, and oral communication skills.

• Understands and listens to team needs while fostering collaborative and productive team environments.

• Identifies issues but also offers solutions to address them.

• Exhibits a degree of ingenuity, creativity, and resourcefulness in a matrix organization.

• Proficient in Excel, PowerPoint, Visio, Word, and SharePoint.

• Ability to travel domestically and internationally, as required.

• 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.