Associate Director, Drug Substance Manufacturing

Job Description: • build and foster strong collaborative partnerships with CDMOs for drug substance process development, characterization and technology transfer activities • aid in developing robust drug substance 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 reflective of regulatory guidance and agency expectations and utilizing statistical and characterization methods that are appropriate for late-stage process development • review and approve DS related manufacturing documents, i.e. master batch records, change controls, plans, protocols, reports, and deviations as required • support process trending analysis for existing and next-generation manufacturing processes, tying process development knowledge and experience to GMP manufacturing performance • conduct CDMO site visits 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 dossier sections for clinical trials and commercial licensure • interface with quality assurance to establish and maintain drug substance related 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 • experienced in process development, manufacture, and scale-up of mammalian or microbial processes, ideally in both upstream and downstream • liquid formulation development expertise is a plus • experience in establishment and qualification of small-scale models for manufacturing process characterization • understanding of relevant protein related 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 complex 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 current regulatory guidance and expectations for clinical and commercial biologics products • demonstrates technical proficiency, collaboration with others and independent thought in suggesting project design and strategy • must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills • demonstrates collaborative communication and problem-solving spirit Benefits: • medical, dental and vision coverage • life insurance • disability insurance • 401(k) savings plan • flexible spending accounts • employee assistance program • tuition reimbursement program • voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance • time off pursuant to its sick time policy • flex-able vacation policy • parental leave policy Apply Now Apply Now