industry, with substantial experience in GMP Quality Control laboratories. Minimum of five years of direct people-management... with organizations comparable to 80+ employees and contractors strongly preferred. Strong experience supporting biologics...
and technology enablement. Oversees direct report’s product assignments and ensures collaboration and a cohesive and integrated... regulatory strategy from early development through approval and marketing. Provides guidance and coaching to direct reports...
innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic... are biologics production using fermentation and cell culture platforms and filling and freeze-drying. This position will help...
readiness for a biologics manufacturing site, ensuring that all key workstreams are aligned, integrated, and prepared... across teams without direct people or budget management responsibility, providing strategic guidance to de-risk and optimize...
schedule, shift, and personnel. Essential Job Duties: Responsible for equipment setup and operation in a biologics... operations. Serves in a leadership role in the absence of direct supervision. Other duties may be assigned...
robustness post-transfer. The Senior Specialist will lead cross-functional technical projects (without direct reports), train... Required Skills: Biological Sciences, Biologics, Biopharmaceuticals, Cross-Functional Project Management, Downstream Processing, Fill...
schedule, shift, and personnel. Essential Job Duties: Responsible for equipment setup and operation in a biologics... operations. Serves in a leadership role in the absence of direct supervision. Other duties may be assigned...
experience commercializing high-cost specialty biologics or infused/injectable therapies, including familiarity with buy-and-bill.... We would prefer for you to have: Direct experience in neuro-immunology, complement biology, or FcRn-targeted therapies. Prior...
successful product development, submission, and lifecycle management for drugs, biologics, and medical devices utilized in expeditionary..., biologics, or devices). Other Experience: Proven experience preparing and reviewing formal FDA submissions. Preferred...
(drugs, biologics, or devices). Other experience: Proven experience preparing and reviewing formal FDA submissions..., ambition, and respect in our work and communities through , a philanthropic group focused on giving back through direct...