This role qualifies for an enhanced Employee Referral Bonus in the amount of $3,500. Please refer to these process and eligibility requirements prior to submitting your referral 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...

Site Name: USA - Maryland - Rockville Posted Date: Sep 9 2024 The Rockville Biopharm site exists to produce and deliver biopharmaceutical drug substance of the highest quality in a safe, compliant, reliable and cost-effective manner for our patients. Our vision is to be wholly entrusted to make innovative, high-quality medicines by leveraging the best talent and technology, on a platform of continuous improvement, to supply every patient, every time. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Possesses expertise and functional knowledge of the following areas and ability to perform the activity with minimal guidance and producing quality results: Preparation, cleaning, sterilization, batching, pasteurization or filtration and delivery of media and solutions for cell culture and purification operations. Perform the set-up, operation, cleaning and break-down of process...

Site Name: USA - Maryland - Rockville, USA - District of Columbia - Washington Dc, USA - Maryland - Baltimore Posted Date: Jun 19 2024 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. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We’re uniting science, technology and talent to get ahead of disease together. Job Purpose: Ensure the development and execution of the appropriate Regulatory strategy(ies) for assigned asset(s), across all stages of the product development and consistent with the Vaccines...

Site Name: USA - Maryland - Rockville, USA - Pennsylvania - Upper Providence Posted Date: Jun 5 2024 Are you looking for a regulatory leadership role where you can build advocacy and accelerate product development and licensure on a global scale, but with a focus on US? If so, this Director, Global Regulatory Affairs, Vaccines role could be an exciting opportunity to explore. As a Director, Regulatory Affairs, Vaccines you will e nsure the development and execution of the appropriate Regulatory strategy(ies) for assigned US asset(s), across all stages of the product life cycle and consistent with the Vaccines Development Strategy/Integrated Asset Plan (IAP). This goal has to be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process / policy and with regional regulatory requirements to deliver the best possible labelling commensurate with the available data. Key Responsibilities: Accountable to the asset...

Site Name: USA - Maryland - Rockville Posted Date: Sep 5 2024 Are you looking for an opportunity to enhance your facilities expertise while providing technical support for capital improvement projects and equipment upgrades involving stationary and rotating equipment? If so, this is the role for you. The Utility Technician will be responsible for providing input to the Supervisor Facilities when discussing departmental decisions concerning maintenance and repair of utility and process equipment. The typical work hours for this position are a standard workday and 40-hour work week, with shift work being a possibility depending on manufacturing demand. There is also an on-call rotation consisting of 24/7 support for alarm monitoring and emergency services. Some travel may be required. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Performs maintenance, troubleshooting, and...

Site Name: USA - Maryland - Rockville Posted Date: Sep 3 2024 GSK is currently looking for an Automation Engineer to join our team in Rockville, MD. As the Automation Engineer, you will be responsible for designing, implementing, and supporting the process systems and utilities for the site. This includes providing control system engineering and project management services for the manufacturing, building and utility equipment to support operations, validation and capital projects . KEY RESPONSIBILITIES: Prioritize all work requests for assigned area and oversee project execution to ensure requirements are met, timelines are met, customer needs are addressed and projects align with GSK goals Ensure all projects are compliant (cGMP, SOPs, OSHA, NFP, BOCA/IBC, Local and National Codes, etc.) and are executed with good engineering practice Demonstrate good project management skills (schedule, cost, communications) and coordinate outside and internal resources to execute...

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...

Site Name: USA - Maryland - Rockville Posted Date: Aug 29 2024 GSK is currently looking for an Internal Auditor to join our team in Rockville, MD. In this role, you’ll manage the site Management Monitoring, Internal Audit (Internal Business Management) and Site Managed External Supplier Audit Programs. Provide guidance to the site in the area of cGMP compliance. Handle the coordination of CAPAs (CAs) within MERP and VQMS for audit observations. Key Responsibilities: Acts as a Certified Lead Auditor during Rockville internal and external supplier audits. Generates and obtains approval for audit plan on an annual basis. Holds meetings as required to review audit plan, as well as holding meetings to review and explain audit findings with designated members of management. Issues internal and external supplier audit reports using existing format. Reviews responses for adequacy and communicates discrepancies with responses to owners. Assists owners as required with responses...

Site Name: USA - Pennsylvania - Upper Providence, Cambridge Park Drive, Collegeville TSA, USA - Maryland - Rockville Posted Date: Aug 28 2024 Job Purpose Ensure the development of appropriate regional regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy. This goal has to be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process / policy and with regional regulatory requirements to deliver the best possible labeling, commensurate with the available data. Key Responsibilities Accountable to GRL and Global Regulatory TA Head for development of appropriate regional and/or global regulatory strategy(ies) and for delivery according to plans. The Regulatory Director may be the single point of contact on assigned asset(s), responsible for regional and global regulatory strategy(ies). In conducting role, planning will be on a multiple year horizon,...

Site Name: USA - Maryland - Rockville, Cambridge Park Drive, Upper Providence Posted Date: Aug 27 2024 Director, Global Regulatory Affairs - RNA vaccines Are you interested in a highly-visible Global regulatory affairs role that allows you to drive strategy and shape integrated regulatory development across portfolios? If so, this Director, Global Regulatory Affairs (RNA Vaccines) could be an ideal opportunity to explore. This role will focus on the development of mRNA based vaccines within GSK. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following... Provide input to/manage regulatory activities in order to obtain Marketing Authorisations for new vaccines as rapidly as possible, with the best possible label, and to maintain these authorisations. Determine from a strategic and scientific perspective the content of regulatory documents submitted to FDA (eg. BLA, sBLA, Q&A,...

Site Name: USA - Maryland - Rockville Posted Date: Aug 14 2024 GSK is currently looking for an Operational Quality Manager to join our team in Rockville, MD. OQ Manager will be responsible for Operational Quality’s day to day activities at LSM/SSM site including batch record review and day to day Quality Operations. The OQ Manager will manage a team of Quality professionals accountable for batch record reviews confirmation of GMP operations in production and support groups i.e. laboratory and engineering. The job holder will be the main liaison with production management team and will participate in daily planning meetings, approve deviations to processes, to support LSM/SSM activities Key Responsibilities: Manage team of Operational Quality professionals (24/7) to support production activities and shop floor presence Ensure Operational Quality schedules and activities support batch record review and batch disposition needs Review and approve deviation reports,...

Site Name: USA - Pennsylvania - Upper Providence, Durham Blackwell Street, USA - Maryland - Rockville Posted Date: Aug 8 2024 Are you energized by a role that drives efficiency in patents and intellectual property? Do you want to work with teams developing medicines and technologies to make a difference in patients’ lives? If so, a Patent Counsel role with GSK could be an ideal opportunity for you. At GSK, respect and inclusivity are at the heart of our culture as a company. GSK fosters diversity, equity and inclusion, reflecting the communities we serve. Diversity is an essential component of success as we aim to positively impact the health of a global community. We believe that inclusion is key to uniting science, technology, and talent to change the course of disease. Together, we embrace individuality and strive to be a force for good. This role will provide YOU the opportunity to lead key activities to progress YOUR career. As a patent attorney at GSK, you will be...

Site Name: USA - Maryland - Rockville Posted Date: Jul 3 2024 Accountable for day-to-day facility wide engineering and maintenance activities ensuring compliance to regulatory requirements, product supply commitments, financial performance while driving continuous improvement and planning proactively for site investments for the long term. Key Responsibilities: Lead all site related engineering and maintenance activities. Additionally, serves on the Site Leadership Team and provides leadership and direction across cross functional groups and serves as site Process Safety Champion. Lead facility compliance to Global Engineering Standards and EH&S requirements. Champion for energy reduction and key sustainability activities for bio-pharm processes which is key in supporting GSK’s low carbon ambitions. Direct engineering efforts in the design, specification, procurement, installation, start-up and commissioning of plant systems and process equipment to meet quality,...

Site Name: USA - Maryland - Rockville, USA - District of Columbia - Washington Dc, USA - Maryland - Baltimore Posted Date: Jun 11 2024 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. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We’re uniting science, technology and talent to get ahead of disease together. Job Purpose: Ensure the development and execution of the appropriate Regulatory strategy(ies) for assigned asset(s), across all stages of the product development and consistent with the Vaccines...

Site Name: USA - Maryland - Rockville, USA - District of Columbia - Washington Dc, USA - Maryland - Baltimore Posted Date: Jun 11 2024 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. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We’re uniting science, technology and talent to get ahead of disease together. Job Purpose: Ensure the development and execution of the appropriate Regulatory strategy(ies) for assigned asset(s), across all stages of the product development and consistent with the Vaccines...

Site Name: USA - Maryland - Rockville, USA - District of Columbia - Washington Dc, USA - Maryland - Baltimore Posted Date: Jun 11 2024 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. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We’re uniting science, technology and talent to get ahead of disease together. Job Purpose: Ensure the development and execution of the appropriate Regulatory strategy(ies) for assigned asset(s), across all stages of the product development and consistent with the Vaccines...

Site Name: Washington DC Posted Date: Sep 9 2024 ViiV Healthcare is a global specialty HIV company, the only one that is 100% focused on researching and delivering new medicines for people living with, and at risk of, HIV. ViiV Healthcare is highly mission-driven in our unrelenting commitment to being a trusted partner for all people living with and affected by HIV. Our aim is to think, act, and connect differently through a focus on education on for the prevention and treatment for HIV. We go to extraordinary lengths to deliver the sorts of breakthroughs, both in prevention, treatments, care solutions and communities, that really count. We go beyond the boundaries of medicine by taking a holistic approach to HIV through developing and supporting sustainable community programs and improving access to care. We are fully committed to push through every challenge until HIV/AIDS is eradicated. ViiV Healthcare has played a significant part in delivering breakthroughs that have...

Site Name: USA - Maryland - Rockville, USA - District of Columbia - Washington Dc, USA - Maryland - Baltimore Posted Date: Jun 19 2024 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. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We’re uniting science, technology and talent to get ahead of disease together. Job Purpose: Ensure the development and execution of the appropriate Regulatory strategy(ies) for assigned asset(s), across all stages of the product development and consistent with the Vaccines...

Site Name: USA - Maryland - Rockville, Durham Blackwell Street, Upper Providence, USA - District of Columbia - Washington Dc, USA - Maryland - Baltimore, Waltham Posted Date: Aug 8 2024 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. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We’re uniting science, technology and talent to get ahead of disease together. Job Purpose: Ensure the development and execution of the appropriate Regulatory strategy(ies) for assigned asset(s), across all stages of the product...

Territory: Washington North, DC - Psychiatry   Target city for territory is Washington D.C. - will consider candidates who live within 40 miles of territory boundaries with access to a major airport. Territory boundaries include: Takoma Park, Washington D.C., Mitchellville & Greenbelt   SUMMARY: Are you a results-driven pharmaceutical sales professional looking to be part of a collaborative, agile and patient-focused organization? At Lundbeck, we are tirelessly dedicated to restoring brain health, so every person can be their best. Inspired and driven by our purpose, we are the only global biopharmaceutical company focused solely on brain diseases. We have a robust and innovative pipeline, bringing forward transformative therapies to address unmet needs in neurology and psychiatry. Join us on our journey of growth!   As a Psychiatry Account Manager, you lead the promotion of our psychiatry portfolio, executing sales and marketing strategies with comprehensive...