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. Our team consists of talented, entrepreneurial-minded professionals dedicated to improving the lives of patients suffering from serious diseases. We strive for data-driven decisions, thoughtful risk-taking, and efficient use of time and funds to best position our ideas for success. We value thoughtful ideas, open communication, and transparency, and are committed to a culture that allows employees to contribute at a high level, grow their careers, and balance their personal and professional ambitions.

Reporting to the VP of Device Development and Commercialization, the Associate Director of Device Development and Manufacturing will lead the technical oversight of process development for assembly, packaging, labelling and functional testing of medical device/drug combination products. This role will also support the technical development of injectable drug delivery devices, including technology selection, development, clinical and commercial production as well as life-cycle management.

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):

• Lead development of the device constituent component of combination products, from initiation through technology selection, development, clinical trials, and commercial launch, ensuring compliance with all regulatory requirements (e.g. Design Control per 21 CFR 820.30).
• Plan and implement experiments to guide the technical assessments and development of devices and combination products.
• Follow design control processes to develop specifications, design verification and validation plans, design transfer plans, and associated completion reports.
• Organize and oversee design validation, including but not limited to human factors engineering assessments.
• Organize and host design review meetings to ensure controlled and documented completion of design control requirements in alignment with quality systems.
• Collaborate with external partners to generate and maintain design specifications and complete all required design control activities.
• Support vendor selection activities as needed.
• Provide input to ensure design robustness and manufacturability.
• Act as Subject Matter Expert (SME) in support of global regulatory filings.
• Create and maintain Design and Process FMEAs and other risk management tools in accordance with ISO 14971 and other applicable regulations.
• Identify critical process parameters and develop control plans to mitigate risks.
• Assist in the development of Validation Plans, execution of I/O/PQ’s as well as process validations for combination products in accordance with established regulations, corporate policies and procedures, and approved site.
• Lead technology and knowledge transfer activities to external contract manufacturing sites (CMOs), including component specifications, test methods, equipment specification development, vendor / equipment selection, vendor management, acceptance testing, and qualification activities.
• Perform root cause analysis for major manufacturing investigations and product complaint trends. This includes forensic analysis of complaints, and application of engineering tools (IE: Design of Experiments).

Qualifications:

• Bachelors of Science/Engineering in Mechanical, Biomedical, Industrial Engineering, or relevant technical discipline and a minimum of 10 years relevant industry experience. Advanced Degree (MS/M Eng) preferred.
• Process development and engineering experience in the Medical Device, Pharmaceutical or Biotechnology industry, with expertise in aseptic processing (including filling), device assembly, labeling and automated inspection. Experience with combination products such as autoinjectors and on-body drug delivery devices a plus.
• Demonstrated knowledge and experience providing technical oversight to drug products regulated under ISO 13485, ISO 11608 and US CFR 820.
• Demonstrated knowledge and experience with design controls, technology transfer and validation principles for device and combination products.
• Strong technical writing skills to draft protocols, reports, test methods, procedures, work instructions, regulatory filing and provide responses to questions from health authorities.
• Ability to use risk management tools, such as pFMEA, root cause analyses, etc.
• Experience in preparation of source documents to support regulatory filings.
• Strong organizational skills to manage resources effectively and maintain a high level of productivity within budget and timelines in a dynamic environment.
• Proactive, motivated, collaborative and accountable.
• Extensive intermediate to advanced computer skills (Microsoft Project, Microsoft Excel, Microsoft PowerPoint, and SmartSheet).
• Strong commitment to ethical standards
• 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 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.