GlaxoSmithKline
Senior Manager/Associate Director - Biologic Services (conjugation)
GlaxoSmithKline, Collegeville, Pennsylvania, United States, 19426
Site Name:
USA - Pennsylvania - King of Prussia, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper ProvidencePosted Date:
Aug 27 2024Senior Manager/Associate Director, Biologic Services, Strategic External Development
will be a subject matter expert, who has established a deep understanding of the modality of antibody-drug conjugates (ADCs), providing technical guidance and support to the advancement of cost effective, and safe manufacturing processes for the manufacture of antibody-drug conjugates (ADCs) drug substance.The incumbent will be responsible for establishing and maintaining a solid understanding of current industry trends with ADC payload linker and conjugation technologies, supporting due diligence projects for antibody-drug conjugates (ADCs) assets, interacting with internal and/or external research and development groups to support pre-clinical study material generation, and supporting clinical phase conjugation process development and technology transfer activities as needed. This role extends further to act as a SME to address specific dossier considerations for ADC regulatory submissions and/or patent filings.This position is integral to the advancement of GSK's growing portfolio of ADC drug candidates and technology programs. The candidate will be expected to represent GSK at scientific and regulatory meetings as needed.The scope of the role encompasses a wide breadth of lifecycle, ranging from preclinical toxicity process, first-time in-patient process development, late-stage development, and process validation and commercialization. In this role, the candidate will be expected to work in a cross-functional team environment to act as a conjugation SME, provide technical support and troubleshooting to ADC project teams to address technical challenges and ensure successful delivery with regards to conjugation process development and technology transfer. The candidate will also contribute to the identification and selection of Contract Research Organizations (CROs) and Contract Development Manufacturing Organizations (CDMOs) and building/maintaining strong working relationships with their respective technical staff and management.This position will require travel, not to exceed 30% (domestic and international).This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:Serve as a conjugation SME to support the development and scale up of antibody-drug conjugate development programs along with supporting other Biopharma projects.Collaborate and coordinate in cross-functional teams, both internally and externally with in-license partners and CDMOs for developing robust, scalable, cost effective and safe ADC conjugation processes.Troubleshoot new and existing product or process issues related to yield, quality, and throughput for ADC projects.Support due diligence projects for ADC assets.Interact with internal and/or external research and development groups to support pre-clinical study material generation, and support clinical phase conjugation process development and technology transfer activities.Prepare CMC documentation for regulatory and/or patent filings and prepare/reconcile responses for responsible topics.Establish and maintain a solid understanding of current trends in ADC payload linker and conjugation technologies.Provide clear communication to cross functional teams and functional line management regarding progress against technical objectives/milestones.Ensure well-organized, clear and complete documentation of all activities across areas of responsibility.Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:Ph.D. in engineering, chemistry, biology, or closely related fields with 5+ industry experienceOr, MS with 7+ industry experience.Or, BS with 10+ years of industry experienceExperience with ADC conjugation/bio-conjugation process development and technology transfer.Experience building relationships and working with ADC conjugation CDMOs.Experience with cGMP regulations.Preferred Qualifications:If you have the following characteristics, it would be a plus:Experience in preparing CMC documentation for regulatory submissions.Proven ability to manage projects and work with cross-functional teams comprised of internal and/or external contacts.Excellent written and oral communication skills, including the maintenance of technical data and reports; proactive collaboration in a multi-disciplinary business and science team environment is essential.Experience with vaccines.Experience working in R&D, understand ADC payload/linker design principles, have good understanding of ADC molecules' mechanisms of action.Experience with design of experiments (DoE) and modeling tools.Experience in preparing regulatory CMC sections for ADC molecules.
#J-18808-Ljbffr
USA - Pennsylvania - King of Prussia, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper ProvidencePosted Date:
Aug 27 2024Senior Manager/Associate Director, Biologic Services, Strategic External Development
will be a subject matter expert, who has established a deep understanding of the modality of antibody-drug conjugates (ADCs), providing technical guidance and support to the advancement of cost effective, and safe manufacturing processes for the manufacture of antibody-drug conjugates (ADCs) drug substance.The incumbent will be responsible for establishing and maintaining a solid understanding of current industry trends with ADC payload linker and conjugation technologies, supporting due diligence projects for antibody-drug conjugates (ADCs) assets, interacting with internal and/or external research and development groups to support pre-clinical study material generation, and supporting clinical phase conjugation process development and technology transfer activities as needed. This role extends further to act as a SME to address specific dossier considerations for ADC regulatory submissions and/or patent filings.This position is integral to the advancement of GSK's growing portfolio of ADC drug candidates and technology programs. The candidate will be expected to represent GSK at scientific and regulatory meetings as needed.The scope of the role encompasses a wide breadth of lifecycle, ranging from preclinical toxicity process, first-time in-patient process development, late-stage development, and process validation and commercialization. In this role, the candidate will be expected to work in a cross-functional team environment to act as a conjugation SME, provide technical support and troubleshooting to ADC project teams to address technical challenges and ensure successful delivery with regards to conjugation process development and technology transfer. The candidate will also contribute to the identification and selection of Contract Research Organizations (CROs) and Contract Development Manufacturing Organizations (CDMOs) and building/maintaining strong working relationships with their respective technical staff and management.This position will require travel, not to exceed 30% (domestic and international).This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:Serve as a conjugation SME to support the development and scale up of antibody-drug conjugate development programs along with supporting other Biopharma projects.Collaborate and coordinate in cross-functional teams, both internally and externally with in-license partners and CDMOs for developing robust, scalable, cost effective and safe ADC conjugation processes.Troubleshoot new and existing product or process issues related to yield, quality, and throughput for ADC projects.Support due diligence projects for ADC assets.Interact with internal and/or external research and development groups to support pre-clinical study material generation, and support clinical phase conjugation process development and technology transfer activities.Prepare CMC documentation for regulatory and/or patent filings and prepare/reconcile responses for responsible topics.Establish and maintain a solid understanding of current trends in ADC payload linker and conjugation technologies.Provide clear communication to cross functional teams and functional line management regarding progress against technical objectives/milestones.Ensure well-organized, clear and complete documentation of all activities across areas of responsibility.Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:Ph.D. in engineering, chemistry, biology, or closely related fields with 5+ industry experienceOr, MS with 7+ industry experience.Or, BS with 10+ years of industry experienceExperience with ADC conjugation/bio-conjugation process development and technology transfer.Experience building relationships and working with ADC conjugation CDMOs.Experience with cGMP regulations.Preferred Qualifications:If you have the following characteristics, it would be a plus:Experience in preparing CMC documentation for regulatory submissions.Proven ability to manage projects and work with cross-functional teams comprised of internal and/or external contacts.Excellent written and oral communication skills, including the maintenance of technical data and reports; proactive collaboration in a multi-disciplinary business and science team environment is essential.Experience with vaccines.Experience working in R&D, understand ADC payload/linker design principles, have good understanding of ADC molecules' mechanisms of action.Experience with design of experiments (DoE) and modeling tools.Experience in preparing regulatory CMC sections for ADC molecules.
#J-18808-Ljbffr