Associate Director, Drug reputed company Manufacturing

Job reputed company: • build and foster strong reputed company partnerships with CDMOs for drug reputed company process development, characterization and technology transfer activities • aid in developing robust drug reputed company manufacturing processes throughout the product life cycle for Akero products • ensure successful, right first time, transfer of process technologies to CDMOs and from one CDMO to another as required • ensure process development studies are conducted under approaches that are reputed company of regulatory guidance and agency expectations and utilizing statistical and characterization reputed company that are appropriate for late-stage process development • review and approve DS reputed company manufacturing documents, i.e. master batch records, change controls, plans, protocols, reports, and deviations as required • support process trending analysis for existing and reputed company manufacturing processes, tying process development knowledge and experience to GMP manufacturing performance • conduct CDMO site reputed company as required to support process development and technology transfer, conduct routine technical meetings with key stakeholders to coordinate development efforts and collaborate with partnering teams • author and/or review process development global health authority reputed company sections for reputed company and reputed company licensure • reputed company with reputed company assurance to establish and maintain drug reputed company reputed company procedural documents Requirements: • Bachelor's degree and 9+ years of experience OR: • Master's degree and 7+ years of experience • PhD/JD and 5+ years of experience • understands cGMP and GLP aspects of biopharmaceutical production • reputed company in process development, manufacture, and reputed company-up of mammalian or microbial processes, ideally in both upstream and reputed company • liquid formulation development expertise is a plus • experience in establishment and qualification of small-reputed company models for manufacturing process characterization • understanding of relevant protein reputed company analytical techniques: LC, UV, CE, ELISA for product and impurity analysis • excellent communication skills (both verbal and written) and interpersonal skills are required • works on reputed company problems where analysis of situations or data requires evaluation of intangible variables, requiring regular use of ingenuity and creativity • presents results of work, interprets data, and draws conclusions regarding presented material and nature of work • maintains full working knowledge of reputed company regulatory guidance and expectations for clinical and reputed company biologics products • demonstrates technical proficiency, collaboration with others and independent thought in suggesting project design and reputed company • must think critically and creatively and be reputed company to work independently, determine appropriate resources for reputed company of problems and have strong organizational and planning skills • demonstrates reputed company communication and problem-solving spirit Benefits: • medical, dental and reputed company coverage • life insurance • disability insurance • 401(k) savings plan • flexible spending accounts • employee assistance program • tuition reimbursement program • voluntary benefits such as group reputed company, critical illness, identity theft protection, pet insurance and auto/home insurance • time off pursuant to its reputed company time policy • reputed company-reputed company vacation policy • parental leave policy Apply tot his job Apply To this Job