and Compliance background (Biologics, Drug, regulation), and understanding of the drug development lifecycle. This position... from fully-and partially dedicated resources;ability to manage through influence. Experience with direct FDA interaction...
-related field. Experience: • 1+ years of experience in direct utilization of problem-solving tools (Root Cause Analysis... writing. • 3+ years of experience working in a regulated environment, preferably in biologics/pharmaceuticals. Knowledge...
. This role is best suited for candidates with direct, hands-on experience in therapeutic siRNA discovery, where siRNA biology... quantification. Direct experience supporting antibody-based or antibody-enabled delivery strategies, including antibody conjugates...
therapeutic modalities, such as ADCs, biologics, cell therapies, or other advanced platforms. Deep financial acumen including... committees. Direct experience supporting or leading CDMO strategy or partnerships. Strong network within the VC/PE community...
in Regulatory Affairs globally during development, registration and/or post-marketing for Biologics, Vaccines and/or Small Molecules..., including direct experience in strategic Labeling content development and management and interacting with Health Authorities...
or in an FDA regulated industry (drugs/biologics) Experience using Trackwise system Experience working in a laboratory... employee selection process, please direct your inquiries to our HR Department ([email protected])....
product, process, and/or system related quality activities follow Corporate, governmental, and local regulations. Direct staff... of QA systems and GxP compliance requirements including regulations and standards applicable to medical devices, biologics...
in direct utilization of problem-solving tools (Root Cause Analysis and/or LEAN/six sigma experience) with demonstrated success... environment, preferably in biologics/pharmaceuticals. Knowledge, Skills, and Abilities: Solid technical writing...
. Leads cross-functional teams without direct authority, promoting accountability, collaboration, and shared ownership.... Minimum of 2 years direct experience in project management within the pharmaceutical, biotechnology, or biopharma industry...
within the Pharmaceutical, Biologics, Medical Device or Health Care Industry, which applies Quality Assurance or Quality... and testing of pharmaceutical and biologics products. Familiar with ISO requirements. Good, verbal, written and negotiations...