Site Name: USA - Pennsylvania - Upper Providence, Belgium, UK - Hertfordshire - Stevenage, UK - London, UK - London - New Oxford Street, USA - Massachusetts - Cambridge, USA - Massachusetts - Waltham, USA - North Carolina - Durham, USA - Pennsylvania - Philadelphia Posted Date: Sep 12 2024 Are you looking for a role where you will serve as a key strategic partner representing Global Regulatory activities? If so, this Director of Regulatory Affairs, CMC could be an exciting opportunity to explore. This role will provide strategic direction and guidance on both global project and key strategic business initiatives. Within Global Regulatory Affairs, our Chemistry, Manufacturing and Controls (CMC) organization provides regulatory leadership to CMC development teams and the Pharma Supply Chain organization to enable approval of new medicines and uninterrupted supply of our medicines to patients. Our work spans all formulation types, novel technologies, and multiple modalities for...

Site Name: USA - Pennsylvania - Upper Providence, Belgium, UK - Hertfordshire - Stevenage, UK - London, UK - London - New Oxford Street, USA - Massachusetts - Cambridge, USA - Massachusetts - Waltham, USA - North Carolina - Durham, USA - Pennsylvania - Philadelphia Posted Date: Sep 12 2024 Are you looking for a role where you will serve as a key strategic partner representing Global Regulatory activities? If so, this Director of Regulatory Affairs, CMC could be an exciting opportunity to explore. This role will provide strategic direction and guidance on both global project and key strategic business initiatives. Within Global Regulatory Affairs, our Chemistry, Manufacturing and Controls (CMC) organization provides regulatory leadership to CMC development teams and the Pharma Supply Chain organization to enable approval of new medicines and uninterrupted supply of our medicines to patients. Our work spans all formulation types, novel technologies, and multiple modalities for...

Site Name: USA - Pennsylvania - Upper Providence, Belgium, UK - Hertfordshire - Stevenage, UK - London, UK - London - New Oxford Street, USA - Massachusetts - Cambridge, USA - Massachusetts - Waltham, USA - North Carolina - Durham, USA - Pennsylvania - Philadelphia Posted Date: Sep 12 2024 Are you looking for a role where you will serve as a key strategic partner representing Global Regulatory activities? If so, this Director of Regulatory Affairs, CMC could be an exciting opportunity to explore. This role will provide strategic direction and guidance on both global project and key strategic business initiatives. Within Global Regulatory Affairs, our Chemistry, Manufacturing and Controls (CMC) organization provides regulatory leadership to CMC development teams and the Pharma Supply Chain organization to enable approval of new medicines and uninterrupted supply of our medicines to patients. Our work spans all formulation types, novel technologies, and multiple modalities for...

Site Name: USA - Pennsylvania - Upper Providence, Belgium, UK - Hertfordshire - Stevenage, UK - London, UK - London - New Oxford Street, USA - Massachusetts - Cambridge, USA - Massachusetts - Waltham, USA - North Carolina - Durham, USA - Pennsylvania - Philadelphia Posted Date: Sep 12 2024 Are you looking for a role where you will serve as a key strategic partner representing Global Regulatory activities? If so, this Director of Regulatory Affairs, CMC could be an exciting opportunity to explore. This role will provide strategic direction and guidance on both global project and key strategic business initiatives. Within Global Regulatory Affairs, our Chemistry, Manufacturing and Controls (CMC) organization provides regulatory leadership to CMC development teams and the Pharma Supply Chain organization to enable approval of new medicines and uninterrupted supply of our medicines to patients. Our work spans all formulation types, novel technologies, and multiple modalities for...

Site Name: USA - Pennsylvania - Upper Providence, Belgium, UK - Hertfordshire - Stevenage, UK - London, UK - London - New Oxford Street, USA - Massachusetts - Cambridge, USA - Massachusetts - Waltham, USA - North Carolina - Durham, USA - Pennsylvania - Philadelphia Posted Date: Sep 12 2024 Are you looking for a role where you will serve as a key strategic partner representing Global Regulatory activities? If so, this Director of Regulatory Affairs, CMC could be an exciting opportunity to explore. This role will provide strategic direction and guidance on both global project and key strategic business initiatives. Within Global Regulatory Affairs, our Chemistry, Manufacturing and Controls (CMC) organization provides regulatory leadership to CMC development teams and the Pharma Supply Chain organization to enable approval of new medicines and uninterrupted supply of our medicines to patients. Our work spans all formulation types, novel technologies, and multiple modalities for...

Site Name: Wavre, GSK HQ, Upper Merion, Upper Providence Posted Date: Sep 2 2024 Location: Wavre (preferred) Other location can be envisaged: US/UK/EU (close to a GSK Site...) Job Purpose As an enterprise level Global Business Process Owner, you will be responsible for forming the strategy and process for the quality devices process. You will review data from systems and users to diagnose where change is needed and implement cross functional organisational change projects which improve business performance. In this role, you will acts as Council Chair to collaborate with key interface partners to maintain, sustain and continuously improve process and associated tools and technologies. The role has accountability for the standardization of the procedures that continue to increase quality culture and performance in alignment with the regulatory authority expectations. You will also provide governance of operational area leads (GSK Site, LOC, Warehousing, Distribution...

Site Name: Wavre, GSK HQ, Upper Merion, Upper Providence Posted Date: Sep 2 2024 Location: Wavre (preferred) Other location can be envisaged: US/UK/EU (close to a GSK Site...) Job Purpose As an enterprise level Global Business Process Owner, you will be responsible for forming the strategy and process for the quality devices process. You will review data from systems and users to diagnose where change is needed and implement cross functional organisational change projects which improve business performance. In this role, you will acts as Council Chair to collaborate with key interface partners to maintain, sustain and continuously improve process and associated tools and technologies. The role has accountability for the standardization of the procedures that continue to increase quality culture and performance in alignment with the regulatory authority expectations. You will also provide governance of operational area leads (GSK Site, LOC, Warehousing, Distribution...

A career in Boston - main video (youtube.com) At 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. In the plan to create a new hub for mRNA-based vaccines in Cambridge, we are building new laboratories that will be focused on mRNA...

A career in Boston - main video (youtube.com) At 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. In the plan to create a new hub for mRNA-based vaccines in Cambridge, we are building new laboratories that will be focused on mRNA...

Technical Development Leader A career in Boston - main video - YouTube At 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. The Technical Development Leader is accountable to lead the CMC development of novel vaccine technologies and...

GSK Technical Development Leader A career in Boston - main video - YouTube At 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. The Technical Development Leader is accountable to lead the CMC development of novel vaccine...

Site Name: USA - Pennsylvania - Upper Providence, Belgium-Rixensart, Ware RD, Zebulon Posted Date: Oct 9 2024 We are seeking a highly motivated Clinical Supply Chain Manager that thrives in a fast-paced and dynamic environment while working on multi-disciplinary teams. The Supply Chain Manager (SCM) role provides strategic oversight of the end-to-end supply chain for assigned GSK R&D investigational assets. The SCM is accountable for determining supply strategies that successfully deliver investigational medicines to patients while ensuring the supply chain delivers results that support GSK R&D registration & launch milestones. The SCM is responsible for influencing clinical plans relative to investigational product (IP) supply and determining optimal supply strategies that are patient-focused, risk-adjusted, and cost effective. Furthermore, the SCM follows through on supply chain performance to ensure the successful execution of the supply chain. This role...

Site Name: USA - Pennsylvania - Upper Providence, Belgium-Rixensart, Ware RD, Zebulon Posted Date: Oct 9 2024 We are seeking a highly motivated Clinical Supply Chain Manager that thrives in a fast-paced and dynamic environment while working on multi-disciplinary teams. The Supply Chain Manager (SCM) role provides strategic oversight of the end-to-end supply chain for assigned GSK R&D investigational assets. The SCM is accountable for determining supply strategies that successfully deliver investigational medicines to patients while ensuring the supply chain delivers results that support GSK R&D registration & launch milestones. The SCM is responsible for influencing clinical plans relative to investigational product (IP) supply and determining optimal supply strategies that are patient-focused, risk-adjusted, and cost effective. Furthermore, the SCM follows through on supply chain performance to ensure the successful execution of the supply chain. This role...

GSK We are seeking a highly motivated Clinical Supply Chain Manager that thrives in a fast-paced and dynamic environment while working on multi-disciplinary teams. The Supply Chain Manager (SCM) role provides strategic oversight of the end-to-end supply chain for assigned GSK R&D investigational assets. The SCM is accountable for determining supply strategies that successfully deliver investigational medicines to patients while ensuring the supply chain delivers results that support GSK R&D registration & launch milestones. The SCM is responsible for influencing clinical plans relative to investigational product (IP) supply and determining optimal supply strategies that are patient-focused, risk-adjusted, and cost effective. Furthermore, the SCM follows through on supply chain performance to ensure the successful execution of the supply chain. This role supports Phase I through IV GSK sponsored clinical studies as well as investigator sponsored trials and...

Site Name: UK - Hertfordshire - Stevenage, Belgium-Rixensart, UK - Hertfordshire - Ware, USA - Pennsylvania - Upper Providence Posted Date: Oct 7 2024 Are you energized by a highly visible senior R&D Global Clinical Supply Chain (CSC) leadership role that will allow you to drive and shape scientific innovation across GSK's vaccine and medicine portfolio? If so, the Executive Director Clinical Interface may be an exciting opportunity to explore. The primary purpose of the Executive Director Clinical Interface is to lead the R&D Clinical Supply Management for Medicines and Vaccines. This includes delivering optimized demand/supply planning and supply chain setup, scenario planning, and input into study delivery teams across the entire R&D Portfolio, including ViiV. The role ensures the supply and oversight of clinical supply to all R&D clinical programs/studies, R&D supported studies, and R&D Managed Access Programs for Vaccines and Medicines. The...

Ultragenyx Why Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won't go - challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them. Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth -...

GSK Are you energized by a highly visible senior R&D Global Clinical Supply Chain (CSC) leadership role that will allow you to drive and shape scientific innovation across GSK's vaccine and medicine portfolio? If so, the Executive Director Clinical Interface may be an exciting opportunity to explore. The primary purpose of the Executive Director Clinical Interface is to lead the R&D Clinical Supply Management for Medicines and Vaccines. This includes delivering optimized demand/supply planning and supply chain setup, scenario planning, and input into study delivery teams across the entire R&D Portfolio, including ViiV. The role ensures the supply and oversight of clinical supply to all R&D clinical programs/studies, R&D supported studies, and R&D Managed Access Programs for Vaccines and Medicines. The role provides high impact strategic support and leadership with strong Patient Focus, engaging directly with senior leaders within MDS, TRD,...

Site Name: USA - Pennsylvania - King of Prussia Posted Date: Oct 4 2024 Job title: Scientific Leader, Downstream Process Development **LOCATION: King of Prussia, PA & Upper Merion - onsite** Are you looking for a challenging opportunity that allows you to leverage your technical expertise to accelerate delivery in biopharmaceuticals? If so, this Scientific Leader, Biopharm Downstream Process Development role could be an exciting opportunity to explore. GlaxoSmithKline (GSK) is a world-leading research-based pharmaceutical company that combines both individual talent and technical resources to create a platform for the delivery of strong growth in a rapidly changing healthcare market. Our mission is to improve the quality of human life by enabling people to do more, feel better, and live longer. Drug Substance Development (DSD) is a highly experienced Chemistry, Manufacturing, and Controls (CMC) organization accountable for delivering robust, cost-effective, and...

Ultragenyx Why Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won't go - challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them. Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth -...

Ultragenyx Why Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won't go - challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them. Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth -...