GlaxoSmithKline
Principal Scientist, MAPS
GlaxoSmithKline, Cambridge, Massachusetts, us, 02140
Site Name:
Cambridge Binney StreetPosted Date:
Nov 7 2024The Principal Scientist, MAPS will be a part of the Process Development group under Technical R&D.The Principal Scientist is expected to design and execute scientific studies in support of technical programs as they progress from early development into Phase I/ II, Phase III, technology transfer and process performance qualification at the intended commercial site.The Principal Scientist is expected to support development of novel, next generation approach in the vaccines and immunotherapies targeting infectious and other immune mediated diseases. This novel and highly efficient vaccine technology – called Multiple Antigen Presenting System (MAPS) – enables the high affinity binding of protective polysaccharides as well as proteins in a single vaccine, uniquely inducing a broad and protective B-cell and T-cell immune response.This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:Design, manage, and execute studies relevant to process development to advance novel vaccine programs from preclinical through clinical stages.Support and manage novel programs including in-house development, tech transfer to CMOs and providing oversight to cGMP manufacturing.Develop new processes or improve existing processes using scientific expertise, literature review or by seeking inputs from Subject Matter Experts.Provide scientific/technical expertise to develop new Biochemical/ Biophysical methods to support vaccine process development.Analyze data from process development studies and author reports for internal and external submission, including regulatory agencies such as the FDA.Understand project timelines/deliverables, support and coordinate cross-functional activities to achieve team and company goals.Mentor and provide leadership and support to other members in the team.Why you?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:Ph.D. in science related fields such as Chemistry/Biochemistry/Biology/Molecular Biology/Chemical Engineering with 3+ years of pharmaceutical experienceExperience in protein purification and chromatography and/or conjugation chemistryPreferred Qualifications:If you have the following characteristics, it would be a plus:Experience with TFF or UF/DFExperience with process development, scale-up experience, and assay development is preferred.Polysaccharide chemistry, characterization, and purification experienceExperience in process design, scale-ups, technology transfers in a clinical and commercial spaceExperience with CMC attributes and regulatory submissions
#J-18808-Ljbffr
Cambridge Binney StreetPosted Date:
Nov 7 2024The Principal Scientist, MAPS will be a part of the Process Development group under Technical R&D.The Principal Scientist is expected to design and execute scientific studies in support of technical programs as they progress from early development into Phase I/ II, Phase III, technology transfer and process performance qualification at the intended commercial site.The Principal Scientist is expected to support development of novel, next generation approach in the vaccines and immunotherapies targeting infectious and other immune mediated diseases. This novel and highly efficient vaccine technology – called Multiple Antigen Presenting System (MAPS) – enables the high affinity binding of protective polysaccharides as well as proteins in a single vaccine, uniquely inducing a broad and protective B-cell and T-cell immune response.This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:Design, manage, and execute studies relevant to process development to advance novel vaccine programs from preclinical through clinical stages.Support and manage novel programs including in-house development, tech transfer to CMOs and providing oversight to cGMP manufacturing.Develop new processes or improve existing processes using scientific expertise, literature review or by seeking inputs from Subject Matter Experts.Provide scientific/technical expertise to develop new Biochemical/ Biophysical methods to support vaccine process development.Analyze data from process development studies and author reports for internal and external submission, including regulatory agencies such as the FDA.Understand project timelines/deliverables, support and coordinate cross-functional activities to achieve team and company goals.Mentor and provide leadership and support to other members in the team.Why you?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:Ph.D. in science related fields such as Chemistry/Biochemistry/Biology/Molecular Biology/Chemical Engineering with 3+ years of pharmaceutical experienceExperience in protein purification and chromatography and/or conjugation chemistryPreferred Qualifications:If you have the following characteristics, it would be a plus:Experience with TFF or UF/DFExperience with process development, scale-up experience, and assay development is preferred.Polysaccharide chemistry, characterization, and purification experienceExperience in process design, scale-ups, technology transfers in a clinical and commercial spaceExperience with CMC attributes and regulatory submissions
#J-18808-Ljbffr