Manager, Device Development & Manufacturing

DescriptionAt 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 Director, Device Development & Manufacturing, the Manager, Device Development & Manufacturing will support the technical development and manufacturing of injectable drug delivery devices, from technology selection through development up to commercialization. The ideal candidate will have knowledge in leading design control activities and the corresponding documentation in compliance with current combination product quality and regulatory standards. Prior experience developing prefilled syringes, autoinjector and/or wearable injectors is highly preferred.This role may be based in our Waltham, MA headquarters, which would be a hybrid role, or it can also be fully remote. Our office-based employees are required to work in the office three (3) days a week. If remote, travel to headquarters for meetings would be required at the discretion of management.Responsibilities (including, but not limited to):Participate in vendor selection process for drug delivery devices, device assembly CMOs, and analytical test labsPlan and coordinate early formative human factors assessments with external vendor(s)Support 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 requirementsWork with CMC team to generate source documentation and contribute to preparation of regulatory submissions, acting as subject mater expert for device and combination productsFollow design and development processes to develop specifications, design verification and validation plans and protocols, design transfer plans, and associated completion reportsEstablish design outputs for the device constituent such as technical drawings, schematics, and product specificationsLead design verification testing activities with external vendorsLead cross-functional team in conducting and maintaining design, use, and process risk assessmentsEnsure product design is adequately translated into production specifications at CMOs (design transfer)Support manufacturing process development and process validation activities at CMOsSupport design validation activities, including but not limited to human factors engineering assessmentsSupport design and development of product packaging and labeling (e.g., Instructions for Use)Organize and host design review meetings to ensure controlled and documented completion of design control requirements in alignment with quality systemsSupport development and validation of analytical methods related to device functional attributesPlan and coordinate feasibility assessments for emerging technologies (e.g., large volume autoinjector, high viscosity formulations) to inform product pipelineCollaborate with competitive intelligence to maintain a high state of awareness of the competitive landscape and state-of-the-art in drug delivery device technology, including trends in clinical practice and regulatory landscapeQualifications:Requires 6+ years’ experience in process or product engineering within the medical device, packaging, or pharmaceutical manufacturing fields. Direct experience with drug delivery devices is highly desirableBS /BA in Mechanical Engineering, product design, life sciences, or other related technical field. Advanced degrees a plusProven record of successful development of medical devices and/or combination productsExpert knowledge of the regulatory and compliance requirements for device design and development and combination products (21 CFR 820, 21 CFR Part 4)Knowledge in the application of ISO 13485, ISO 14971, ISO 10993, ISO 11608, ISO 23908 and other appropriate standardsExperience leading projects with external design, development and manufacturing partnersConstructive partnership and communication skills, both verbally and written, at all levels internally and externallyUnderstanding of statistical sampling and statistical analysis of test resultsStrong commitment to ethical standardsProficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)Ability to travel up to 15%The salary range for this position is commensurate with experienceViridian offers a comprehensive benefits package including:Competitive pay and stock options for all employeesMedical, dental, and vision insurance100% Paid Parental LeaveShort- and long-term disability coverageLife, Travel and AD&D401(k) Company Match with immediate company vestEmployee Stock Purchase planGenerous vacation plan and paid company holiday shutdownsVarious fertility, mental, financial, and proactive physical health programsViridian 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.RequirementsEmployee Type: FT Exempt