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▷ Apply in 3 Minutes! Upstream ManufacturingDirector


Job details
  • Planet Pharma
  • Glasgow
  • 3 days ago

Role: Upstream Manufacturing Director Location: UK(remote based)Full time permanent employment Planet Pharma arerecruiting for an Upstream Manufacturing Director on behalf of aglobal leader and innovator in antibody-drug conjugates (ADCs),specializing in their lifecycle from discovery tocommercialization. The company has advanced technology and robustpipeline extend beyond hematology, targeting solid tumor cancers.Key ResponsibilitiesCollaborate with UK researchers and CMOs totransfer processes, including cell line development and cellculture procedures.Review and analyze upstream Master Batch Recordsfor adherence to process descriptions and compile data intoelectronic databases.Coordinate batch record reviews with qualityteams in a collaborative environment.Analyze process developmentand GMP campaign data to optimize cell culture performance andensure process robustness.Monitor and support upstream productionruns, process transfers, characterization, and validation atCMOs.Contribute to writing development reports, INDs, and BLAs,ensuring timely regulatory submissions in collaboration withregulatory teams.You Will HaveMaster’s/PhD in Biochemistry,Chemistry, or related field with extensive biotechnologyexperience.Expertise in GMP upstream/downstream processes, processdevelopment, and technology transfer.Skilled in cell cultureprocess development, optimization, and regulatory responses.Strongexperience in GMP manufacturing and process transitions toCMOs.Proficient in process characterization, master batch recordreviews, and process improvements.Effective communicator, able toarticulate issues to leadership and collaborate with internal teamsand CMOs.We are an equal opportunities Recruitment Business andAgency. We welcome applications from all suitably qualifiedcandidates regardless of their race, sex, disability,religion/belief, sexual orientation orage.www.planet-pharma.com

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