Director, Regulatory CMC Device and Combination Products - Waltham, MA

About Jade Biosciences · Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies that address critical unmet needs in autoimmune diseases. Jade's lead candidate, JADE101, targets the cytokine APRIL, and is currently being evaluated ...

We are seeking a highly skilled Director of Combination Product & Device Development to lead the development, · manufacturing, assembly and commercialization of high-concentration biologic delivery systems.Jade Biosciences is focused on developing innovative therapies for autoimm ...

Kiniksa is seeking a highly motivated Manager, Combination Product Development to join our Drug Product Development team in Lexington, MA. · ...

· Job Title:  Engineer, Combination Product Design and Characterization  (JP11553) · Location: Cambridge, MA · Business Unit: Device Strategy Technology Assessment · Employment Type:  Contract · Duration: 12 months (with likely extensions and/or conversion to permanent) · Rate: ...

· Job Title:  Engineer, Combination Product Design and Characterization  (JP11469) · Location: Cambridge, MA · Business Unit: Device Strategy Technology Assessment · Employment Type:  Contract · Duration: 12 months (with likely extensions and/or conversion to permanent) · Rate: ...

As the Senior Director, Global Regulatory CMC - Drug-Device Combination Products, you will serve as the enterprise regulatory leader for our global device and combination product portfolio. · ...

About This Role · As the Senior Director, Global Regulatory CMC - Drug-Device Combination Products, you will serve as the enterprise regulatory leader for our global device and combination product portfolio. Operating within the Product Delivery Solutions team, you will have end- ...

The Project Manager III will lead large, complex manufacturing programs spanning multiple global sites. · Define and document program scope, execution strategies, resources, deliverables, and milestones using established program management tools · Manage programs against approved ...

The Project Manager III will lead large complex manufacturing programs spanning multiple global sites this role focuses on the execution of programs supporting assembly labeling packaging testing storage and release of medical devicesand drug device combination products. · ...

This is a Hybrid role that involves leading large programs across the globe for manufacturing, testing and storage of medical devices and drug-device combination products. · ...

This is a Hybrid role Full-time, hybrid role; candidate is expected to be on site on Tue, Wed, Thurs Position is based in Worcester, MA Candidate must be able to travel domestically and internationally, if needed As a Manufacturing Program Manager you are responsible for leading ...

This Manufacturing Program Manager will lead large programs involving multiple manufacturing locations across the globe. · ...

This role falls under a global team. The scope of the programs you lead typically includes assembly labeling packaging testing storage and release of new or modified medical devices and drug-device combination products. · ...

+Job summary+We are seeking a highly skilled and experienced Device Quality Engineer to support the development, validation, and launch of pre-filled syringe and autoinjector-based drug-device combination products. · +Qualifications+10+ years of experience in medical device or co ...

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailer ...

At Kailera we are bold authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. · ...

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailer ...

This role involves leading human factors engineering, user insights, and risk management across GSK's medicine and vaccine development portfolio. It requires strategic leadership to assess existing capabilities and improve them continuously. ...

+ In this role you will be responsible for bringing new Drug Delivery Systems through the development process. · You will have considerable cross-functional interaction · with Quality Assurance,Regulatory Affairs,Packaging,Clinicaland Commercial functions. · ...

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-vali ...