Blackwomenintech
Director Physico-Chem & Separations Analytics US
Blackwomenintech, Boston, Massachusetts, us, 02298
A career in Boston – main video - YouTubeAt GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease.We believe the Greater Boston area is an important hub for the biotech and pharma industry, which is why we’ve invested in growing our footprint and expanding our R&D space in Cambridge, with a primary focus on additional state-of-the-art lab space. Here, we will bring together talent and expertise, building upon GSK’s long history of vaccine development, to create globally leading viral capabilities and cutting-edge vaccines technologies, as we add to our robust portfolio targeting infectious diseases at every stage of life.GSK is establishing a new hub for mRNA-based vaccines in the Cambridge (Boston) area where new analytical laboratories will focus on the development of state-of-the-art methods to support deep product understanding, process and product development, and preclinical lot characterization.The role of Director Physico-Chem & Separations Analytics US is new and will pilot two analytical technology platforms in the US: the Phys-Chem analytics (mainly MS, spectroscopy, plate-based assays) and Separations analytics (mainly chromatography and electrophoresis assays).The Phys-Chem & Separations Analytics US platform is an integral part of the global analytical platforms also based in Belgium and Italy, where method development, qualification, validation, and GMP activities (release and stability) are executed.This role is expected to integrate these two analytical platforms into one single team where state-of-the-art analytical methods combining these technologies are developed and applied to new candidate vaccines, with a clear focus on mRNA technologies, as they progress from early development into early clinical phases, ensuring technology transfer within the GSK laboratory network according to project needs.The candidate must demonstrate strong leadership in team management and will help in attracting, developing, and retaining talents in the organization. The candidate will lead group performance through appropriate KPIs and must enjoy working in a multicultural/multidisciplinary global environment, communicating efficiently with peers, and influencing through example.The Director ensures the scientific direction and strategic vision of the Phys-Chem & Separations Analytics platform in agreement with the Global Platform vision and objectives defined by the Global Head, coordinating the work of Associate Scientists, Scientists, Expert Scientists and Scientific Leaders to implement innovative and cutting-edge analytical methods and technologies for mRNA, macromolecules and delivery systems (e.g. proteins, LNP) characterization and testing in line with Quality by Design (QbD) principles, in the area of Phys-Chem & Separations technologies.Key Responsibilities:Build and Integrate a High-Performing Team
of top scientists and drive their integration into the global ARDS department.Cultivate department culture : excellence in science and operations, embracing an open global mindset, fostering a positive culture of transparency and collaboration within the global organization.Lead a Specialized Team
of ~10 people with 3 missions:
Develop next generation analytical methods for next generation mRNA vaccines using innovative Phys-Chem & Separations based technologies and automation in collaboration with the other teams of the global analytical platforms.Apply these methods to early mRNA candidate vaccines in close collaboration with Preclinical, Drug Substance (DS) and Drug Product (DP) teams for deep product understanding, process development support at the preclinical, DS and DP stages.Excel in delivering quality data and sound science to drive decisions for new vaccine candidate projects, as part of end-to-end accelerated vaccine CMC development programs.
Design and drive scientific strategy
for vaccine early development phases and integrate it into the end-to-end CMC strategy. Collaborate closely with the Preclinical, Drug Substance and Drug Product departments, as well as with the other ARDS platforms and other stakeholders to ensure timely delivery.Act as a key opinion leader : think and act strategically, impact and influence within ARDS, across functions and at senior leadership level to continuously improve and shape the CMC strategy & framework.Additional Responsibilities:Serve as a member of the global Phys-Chem and Separations Analytics leadership team, contributing to strategic planning and collaboration across the CMC network (including Belgium, Italy and US sites), and maintaining strong collaboration and interaction both locally and globally with internal (within TRD) and external partners (Discovery, Preclinical, GSC (Global Supply Chain), Quality, Regulatory, Universities, etc.) to develop state-of-the-art techniques and build a team of best-in-class Subject Matter Experts.Foster an enterprise mindset and maximize the efficiency and flexibility potential of the Global Phys-Chem & Separations Analytics platform by promoting an efficient, diverse, and innovative working environment while aligning on global priorities and portfolio management, harmonizing technical capabilities, development approaches, documentation, resource constraints, and appropriate risk-taking.Develop, coach and lead people to promote and maintain excellence, and to create a high performing team with robust succession plans.Support Scientific Leaders in defining a phase-appropriate strategy for the development and implementation of testing methods for candidate vaccines covering the early and late phase development and product launch.Identify risks related to process feasibility, manufacturability, timing, and resource constraints and develop remediation plans. Escalate any technical issues to the Technical Development Team.Influence project priorities, manage the local portfolio, and encourage smart risk-taking to accelerate vaccine development.The successful applicant will spend 3-6 months within the first year in Rockville, MD to support and guarantee a smooth transition of methods and know-how to the new laboratories in Cambridge, MA.Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:PhD in Chemistry, Biotechnology, Biochemistry, Pharmaceutical Sciences, Biology or Chemical engineering or related scientific fields with an additional 8+ years of industry experience in the field.Eight or more years of experience leading a scientific team in analytical sciences in the vaccine field.Five or more years of experience in Phys-Chem & Separations technologies, especially MS, NMR, structural and morphological characterization of macromolecules and vaccine products), LC, GC, electrophoresis, etc.Two or more years of experience in mRNA analytical development.Preferred Qualifications:Proven ability to shape and build high-performing teams, fostering a culture of excellence, creativity, accountability, and flexibility in a collaborative and innovative environment.Higher understanding of early development in the discovery and preclinical phases is required to successfully influence and onboard projects at an early stage.Experience developing and implementing strategies with measurable outcomes.Project Management experience.Fluency in EnglishExceptional communication and interpersonal skills to effectively motivate, mentor, guide team members and manage stakeholders.Capacity to synthesize messages and ability to defend scientific and technical decisions to have constructive interactions and take the right decisions with other Leaders.Must have the ability to work with cross-functional teams.Superlative presentation skills, across lines and levels and with senior stakeholders.Problem-solving ability with limited information available to make decisions and interpretations.Anticipates medium/long-term future issues.Positive, open and can-do mindset.Critical thinking ability is a must.
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of top scientists and drive their integration into the global ARDS department.Cultivate department culture : excellence in science and operations, embracing an open global mindset, fostering a positive culture of transparency and collaboration within the global organization.Lead a Specialized Team
of ~10 people with 3 missions:
Develop next generation analytical methods for next generation mRNA vaccines using innovative Phys-Chem & Separations based technologies and automation in collaboration with the other teams of the global analytical platforms.Apply these methods to early mRNA candidate vaccines in close collaboration with Preclinical, Drug Substance (DS) and Drug Product (DP) teams for deep product understanding, process development support at the preclinical, DS and DP stages.Excel in delivering quality data and sound science to drive decisions for new vaccine candidate projects, as part of end-to-end accelerated vaccine CMC development programs.
Design and drive scientific strategy
for vaccine early development phases and integrate it into the end-to-end CMC strategy. Collaborate closely with the Preclinical, Drug Substance and Drug Product departments, as well as with the other ARDS platforms and other stakeholders to ensure timely delivery.Act as a key opinion leader : think and act strategically, impact and influence within ARDS, across functions and at senior leadership level to continuously improve and shape the CMC strategy & framework.Additional Responsibilities:Serve as a member of the global Phys-Chem and Separations Analytics leadership team, contributing to strategic planning and collaboration across the CMC network (including Belgium, Italy and US sites), and maintaining strong collaboration and interaction both locally and globally with internal (within TRD) and external partners (Discovery, Preclinical, GSC (Global Supply Chain), Quality, Regulatory, Universities, etc.) to develop state-of-the-art techniques and build a team of best-in-class Subject Matter Experts.Foster an enterprise mindset and maximize the efficiency and flexibility potential of the Global Phys-Chem & Separations Analytics platform by promoting an efficient, diverse, and innovative working environment while aligning on global priorities and portfolio management, harmonizing technical capabilities, development approaches, documentation, resource constraints, and appropriate risk-taking.Develop, coach and lead people to promote and maintain excellence, and to create a high performing team with robust succession plans.Support Scientific Leaders in defining a phase-appropriate strategy for the development and implementation of testing methods for candidate vaccines covering the early and late phase development and product launch.Identify risks related to process feasibility, manufacturability, timing, and resource constraints and develop remediation plans. Escalate any technical issues to the Technical Development Team.Influence project priorities, manage the local portfolio, and encourage smart risk-taking to accelerate vaccine development.The successful applicant will spend 3-6 months within the first year in Rockville, MD to support and guarantee a smooth transition of methods and know-how to the new laboratories in Cambridge, MA.Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:PhD in Chemistry, Biotechnology, Biochemistry, Pharmaceutical Sciences, Biology or Chemical engineering or related scientific fields with an additional 8+ years of industry experience in the field.Eight or more years of experience leading a scientific team in analytical sciences in the vaccine field.Five or more years of experience in Phys-Chem & Separations technologies, especially MS, NMR, structural and morphological characterization of macromolecules and vaccine products), LC, GC, electrophoresis, etc.Two or more years of experience in mRNA analytical development.Preferred Qualifications:Proven ability to shape and build high-performing teams, fostering a culture of excellence, creativity, accountability, and flexibility in a collaborative and innovative environment.Higher understanding of early development in the discovery and preclinical phases is required to successfully influence and onboard projects at an early stage.Experience developing and implementing strategies with measurable outcomes.Project Management experience.Fluency in EnglishExceptional communication and interpersonal skills to effectively motivate, mentor, guide team members and manage stakeholders.Capacity to synthesize messages and ability to defend scientific and technical decisions to have constructive interactions and take the right decisions with other Leaders.Must have the ability to work with cross-functional teams.Superlative presentation skills, across lines and levels and with senior stakeholders.Problem-solving ability with limited information available to make decisions and interpretations.Anticipates medium/long-term future issues.Positive, open and can-do mindset.Critical thinking ability is a must.
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