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
• 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