Senior Director, Drug Product CMC - Boston

Join us in shaping the future of multispecific antibodies and in vivo CAR-T therapeutics. · ...

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. · ...

The Director of Regulatory CMC Device and Combination Products will lead combination product regulatory strategy for assigned clinical-stage programs. · Assess and communicate regulatory requirements to ensure all global development activities comply with applicable regulations. ...

We are seeking an accomplished CMC professional to oversee formulation development drug product DP development and manufacturing for our pipeline of biologics ADCs. · Lead formulation DP development and manufacturing strategy for biologics and ADCs. · Direst DP efforts from early ...

Join us in shaping the future of multispecific antibodies and in vivo CAR-T therapeutics. · ...

We are seeking an accomplished CMC professional to oversee formulation development drug product DP development and manufacturing for our pipeline of biologics and ADCs. · A comprehensive understanding of GMP ICH guidelines and regulatory requirements for biologics and ADCs is req ...

Join us in shaping the future of multispecific antibodies and in vivo CAR-T therapeutics. As a key member of our team, you will play a key role in technology transfer, scale-up, and manufacturing initiatives that directly advance our platform. · ...

Join us in shaping the future of multispecific antibodies and in vivo CAR-T therapeutics. · ...

· We are focused on advancing innovation at the intersection of protein and formulation science to help pave the way for groundbreaking high concentration liquid formulations. As part of our team you will drive breakthroughs that could turn the impossible into possible for milli ...

As Senior Associate Scientist within our Early-Stage Drug Product Development (EDPD) team, you'll help deliver Sanofi's promising pipeline of biologic drugs into the clinic and lead efforts to revolutionize the development of patient-centric products. · ...

As Senior Associate Scientist within our Early-Stage Drug Product Development (EDPD) team, you'll help deliver Sanofi's promising pipeline of biologic drugs into the clinic and lead efforts to revolutionize the development of patient-centric products. · ...

This Is What You Will DoThe Director, CMC Team Lead is a strategic leader within the Product Development and Clinical Supply (PDCS) organization within Alexion R&D. · ...

We are seeking an experienced CMC Regulatory Lead to provide strategic and operational leadership for all Chemistry, Manufacturing, and Controls (CMC) regulatory activities. · Develop and execute global CMC regulatory strategies to support IND, CTA, NDA/BLA, and lifecycle submiss ...

We are seeking a highly experienced Senior Vice President, CMC Regulatory Affairs to provide strategic and operational leadership for global CMC regulatory activities across a growing pipeline of innovative therapeutics. · This role is designed for a recognized subject matter exp ...

Antares Therapeutics is seeking an experienced Regulatory Affairs–CMC Strategist (Consultant) to provide senior strategic advisory leadership for global, phase-appropriate CMC regulatory strategies supporting early-stage small molecule product development. · Advanced degree (PhD, ...

Ironwood Pharmaceuticals is a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. · Reporting to the Head of Regulatory Affairs CMC, · ...

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. · ...

We are seeking a highly experienced Vice President, Regulatory Affairs, CMC to provide strategic and operational leadership for global CMC regulatory activities across a growing pipeline of innovative therapeutics. · We seek a recognized subject matter expert in Regulatory Affair ...

Takeda is transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. · ...

We are a forward-looking R&D organization that unlocks innovation and delivers transformative therapies to patients. · Develops executes oversees regulatory submissions preparation per GRA CMC Product Team CMC strategy.Guide team define drive strategy for CMC regulatory dossier c ...