Site Name: UK - London - New Oxford Street, Poznan Grunwaldzka, USA - North Carolina - Durham Posted Date: Dec 5 2024 As CMC Mature Products Regulatory Project Manager you will be responsible for the CMC regulatory activities in the late phase development and / or commercial lifecycle management of GSK products. You will work in cross-functional matrix project teams, which include colleagues from regulatory, development, quality and manufacturing ensuring adequate interaction and partnership in order to define proper regulatory CMC filing strategy. You will maintain high quality standards and seek to raise levels of performance through continuous improvement and an innovative approach in responding to the evolving regulatory environment. We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership,...

GSK As CMC Mature Products Regulatory Project Manager you will be responsible for the CMC regulatory activities in the late phase development and / or commercial lifecycle management of GSK products. You will work in cross-functional matrix project teams, which include colleagues from regulatory, development, quality and manufacturing ensuring adequate interaction and partnership in order to define proper regulatory CMC filing strategy. You will maintain high quality standards and seek to raise levels of performance through continuous improvement and an innovative approach in responding to the evolving regulatory environment. We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We embrace modern work practises; our Performance with Choice...

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 -...

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 -...

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 -...

Legend Biotech USA Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel) in 2017. Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking an Executive Director, Pipeline CMC Technical and Strategic Lead as part of the Technical Development team based in Somerset, NJ. Role Overview...

Legend Biotech USA Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel) in 2017. Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking an Senior Project Manager, CMC as part of the Technical Development team based in Somerset, NJ. Role Overview The Technical Project Manager role...

Site Name: USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Ware, USA - Massachusetts - Waltham Posted Date: Oct 16 2024 Are you interested in a highly-visible US regulatory affairs role that allows you to drive strategy and shape integrated regulatory development across portfolios? If so, this Regulatory Affairs Management Manager could be an ideal opportunity to explore. As a Regulatory Affairs Management Manager/Associate Director, you will be responsible for regulatory submissions, interactions, and strategy related to products within the US. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following... Drives the CMC strategy coordinates the timely preparation and authors, as needed, technical (CMC) regulatory documents to support development/registration/lifecycle maintenance submission content, in accordance with the applicable regulatory & scientific standards, and...

Site Name: USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Ware, USA - Massachusetts - Waltham Posted Date: Oct 16 2024 Are you interested in a highly-visible US regulatory affairs role that allows you to drive strategy and shape integrated regulatory development across portfolios? If so, this Regulatory Affairs Management Manager could be an ideal opportunity to explore. As a Regulatory Affairs Management Manager/Associate Director, you will be responsible for regulatory submissions, interactions, and strategy related to products within the US. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following... Drives the CMC strategy coordinates the timely preparation and authors, as needed, technical (CMC) regulatory documents to support development/registration/lifecycle maintenance submission content, in accordance with the applicable regulatory & scientific standards, and...

GSK Job Description The Reference Material and Reagents Director is accountable for ensuring critical reagents and analytical standards are available for the GSK network. They must be of the required regulatory standards and coordination and supply to GSK sites, CMO and LOC to support end to end supply chain of products to the patient. The role will ensure long term availability and lifecycle management of reference materials for existing and new GSK products. You will ensure outsource partners are maintained, ensuring a priority service to GSK is maintained and that bulk materials are effectively supplied to the outsource partner in a timely manner, along with supporting information to maintain a secure supply of reference materials. Also, ensure GSK customer changes, risks and issues are managed and dealt with associated with the service provided from the outsource partner. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these...

GSK Job Description The Reference Material and Reagents Director is accountable for ensuring critical reagents and analytical standards are available for the GSK network. They must be of the required regulatory standards and coordination and supply to GSK sites, CMO and LOC to support end to end supply chain of products to the patient. The role will ensure long term availability and lifecycle management of reference materials for existing and new GSK products. You will ensure outsource partners are maintained, ensuring a priority service to GSK is maintained and that bulk materials are effectively supplied to the outsource partner in a timely manner, along with supporting information to maintain a secure supply of reference materials. Also, ensure GSK customer changes, risks and issues are managed and dealt with associated with the service provided from the outsource partner. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these...

GSK Job Description The Reference Material and Reagents Director is accountable for ensuring critical reagents and analytical standards are available for the GSK network. They must be of the required regulatory standards and coordination and supply to GSK sites, CMO and LOC to support end to end supply chain of products to the patient. The role will ensure long term availability and lifecycle management of reference materials for existing and new GSK products. You will ensure outsource partners are maintained, ensuring a priority service to GSK is maintained and that bulk materials are effectively supplied to the outsource partner in a timely manner, along with supporting information to maintain a secure supply of reference materials. Also, ensure GSK customer changes, risks and issues are managed and dealt with associated with the service provided from the outsource partner. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these...

Syneos Health Description Clinical Research Associate I Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS...

University of Michigan How to Apply A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in this role and outline your skills and experience that relate to this position. Job Summary The Michigan Youth Violence Prevention Center (MI-YVPC) is seeking a highly motivated and qualified candidate to provide project management support to a Centers for Disease Control (CDC)-funded research center focused on youth gun violence prevention. The selected candidate will assist with evaluations of grassroots, youth-driven gun violence prevention programs. Working in close communication with local staff and community partners, the selected candidate will take a leadership role in coordinating data collection activities at our study site in Muskegon, MI. They will contribute to qualitative and quantitative data analyses and writing up findings. The selected candidate...

AstraZeneca Are you passionate about being a Senior Scientist specializing in Analytical Sciences? The role involves developing cell-based analytical methods aligned with vector and cellular therapy product critical quality attributes (CQAs) to support process development, product characterization, stability, and release testing of engineered cell therapy products. We have an exciting opportunity for you at AstraZeneca! What You'll Do We are seeking a collaborative and highly motivated Senior Scientist with expertise in cell culture, immunological techniques, multi-parametric flow cytometry, and cell-based functional assays to lead bioassay development efforts. This individual will grow, manage, and mentor a laboratory-based team to deliver innovative analytical methods and evaluate new analytical technologies. The role involves developing cell-based analytical methods aligned with vector and cellular therapy product critical quality attributes (CQAs) to support process...

Site Name: USA - Pennsylvania - King of Prussia, Belgium-Wavre, UK - County Durham - Barnard Castle, UK - Hertfordshire - Ware, USA - Maryland - Rockville, USA - Pennsylvania - Upper Providence Posted Date: Dec 4 2024 Job Description The Reference Material and Reagents Director is accountable for ensuring critical reagents and analytical standards are available for the GSK network. They must be of the required regulatory standards and coordination and supply to GSK sites, CMO and LOC to support end to end supply chain of products to the patient. The role will ensure long term availability and lifecycle management of reference materials for existing and new GSK products. You will ensure outsource partners are maintained, ensuring a priority service to GSK is maintained and that bulk materials are effectively supplied to the outsource partner in a timely manner, along with supporting information to maintain a secure supply of reference materials. Also, ensure GSK customer...

Baker Hughes Are you a Field Personnel & Competency Leader that is motivated to deliver? Do you enjoy being part of a team that provides high-quality services for our customers? Do you enjoy building relationships, identifying prospects, and developing people? Join our Flexible Pipe Team! Partner with the best As a Field Personnel & Competency Leader - Flexible Pipe Systems you will lead our Field Personnel & Competency team, focused on developing and maintaining the technical capabilities of our field teams in the oil and gas industry. The successful candidate will be responsible for driving continuous improvement, ensuring compliance with industry standards and regulations, and promoting a culture of safety and operational excellence. As a Field Personnel & Competency Leader - Flexible Pipe Systems you will be responsible for: Lead the Field Service team in the flawless execution of service delivery for our customers....

Sharp HealthCare Hours : Shift Start Time: Variable Shift End Time: Variable AWS Hours Requirement: 8/40 - 8 Hour Shift Additional Shift Information: Weekend Requirements: As Needed On-Call Required: No Hourly Pay Range (Minimum - Midpoint - Maximum): $26.950 - $32.337 - $37.724 The stated pay scale reflects the range that Sharp reasonably expects to pay for this position. The actual pay rate and pay grade for this position will be dependent on a variety of factors, including an applicant's years of experience, unique skills and abilities, education, alignment with similar internal candidates, marketplace factors, other requirements for the position, and employer business practices. What You Will Do To assist the physician and other health care professionals in providing quality care to patients in the Sharp Rees-Stealy Occupational Health Program. Required Qualifications Certification of completion of a Medical...