Manager, Device Development & Manufacturing

Description 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 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 labs

Plan 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 requirements

Work with CMC team to generate source documentation and contribute to preparation of regulatory submissions, acting as subject mater expert for device and combination products

Follow design and development processes to develop specifications, design verification and validation plans and protocols, design transfer plans, and associated completion reports

Establish design outputs for the device constituent such as technical drawings, schematics, and product specifications

Lead design verification testing activities with external vendors

Lead cross-functional team in conducting and maintaining design, use, and process risk assessments

Ensure 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 assessments

Support 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 systems

Support development and validation of analytical methods related to device functional attributes

Plan and coordinate feasibility assessments for emerging technologies (e.g., large volume autoinjector, high viscosity formulations) to inform product pipeline

Collaborate 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 landscape

Qualifications:

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 plus Proven record of successful development of medical devices and/or…