Job Description
- 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
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