in the planning, coordination, and conduct of clinical trials for medical devices, diagnostics, drugs, and biologics to treat... managers on the product development lifecycle, identifying regulatory requirements at each stage for drugs, biologics...
is responsible for direct shopfloor & operational support, deviation management, change control, and standards, sample, data... of 5 years of experience in a cGMP-regulated laboratory environment (Biologics, Vaccines, or Pharmaceutical industry...
understanding of good manufacturing practices to support Clinical Manufacturing Start Up activities, and direct manufacturing... of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred. Driven...
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...
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...
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...
Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs... approximately five scientists and engineers responsible for downstream process development and client program delivery. Direct the...
in the scale-up of biologics for production, procedural documentation development, and design of quality control tests... Direct Deposit & weekly epayroll Referral Bonus Programs Certification and training opportunities Note: Any pay ranges...
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...
, or microbiology within a regulated GMP environment 7+ years of senior/leadership experience with direct accountability for sterile..., and regulatory submissions/inspections Experience with Single-Use Technologies (SUT), biologics, or complex drug product...