, and Manufacturing teams to resolve operational non-conformances and safeguard program timelines. Direct the global GxP vendor... technical depth across GLP, GCP, and GMP regulations encompassing synthetic molecules, biologics, vaccines, and advanced human...
ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone... development and process characterization for multiple biologics programs during pivotal phases (phases II/III and post-launch...
Job Title: Patent Counsel, Biologics - Global Intellectual Property Location: Cambridge, MA About the Job The... Counsel will be an experienced patent attorney responsible for biologics projects on a talented team committed to diversity...
is required (or MS with 10+ years, BS with 12+ years of industry experience) Strong knowledge background and direct experience... and regulatory expectations for biologics gene editing material or cell therapy products is a plus Strong interpersonal skills...
and regulations including Good Manufacturing Practices (GMP), drug and biologics development regulations and guidelines (e.g... of post-approval dossier life cycle management Experience with Orphan Drug Designation, BTD, RMAT, direct interactions...
: Executive Director, Quality - Global Biologics Network As Executive Director, Quality, you will provide strategic leadership... and oversight for Elanco's Global Biologics Manufacturing Network. You will be accountable for defining and executing the global...
, deep cell-based and biochemical assay expertise, direct people leadership, and the ability to translate pharmacology data... compound characterization, lead optimization, and progression decisions. Direct people-management experience, including...
regulatory requirements for biologics or gene therapy products. Solid working knowledge of drug development processes, eCTD... therapy or rare diseases. Direct experience interacting with cross-functional teams, CROs, and regulatory vendors...
education, experience and skills: Minimum Qualifications: Bachelor’s Degree BA/BS Minimum of 3 years of direct selling... Preferred Qualifications: 5 years of direct selling experience to healthcare professionals in the pharmaceutical, biotech...
to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic, we work...-regulated animal health biologics. This role helps maintain biomaterials documentation, monitor inventory, support replacement...