gxp

About the RoleWe are seeking a highly experienced Senior Validation Lead to join our team at Katalyst Healthcares & Life Sciences. As a key member of our team, you will be responsible for leading validation efforts for our Labvantage LIMS system.Key ResponsibilitiesLead validation efforts for Labvantage LIMS, ensuring compliance with GxP regulations and...

Company Overview:Ironwood Pharmaceuticals is a prominent global entity in the gastrointestinal (GI) healthcare sector, dedicated to enhancing the treatment of GI disorders and setting new benchmarks for patient care. We are at the forefront of developing innovative solutions such as LINZESS (linaclotide), the leading branded prescription in the U.S. for...

Job DescriptionGeneral Summary:The Associate Director, Lab Computing Service Management will be a key technical resource in ensuring the planning and delivery of lab operations services for a wide range of commercial-off-the-shelf (COTS) and custom solutions in support of their business partners. This role will partner with DTE and business leadership to...

Company Overview:Ironwood Pharmaceuticals is a prominent player in the gastrointestinal (GI) healthcare sector, dedicated to enhancing the treatment landscape for GI disorders and setting new benchmarks in patient care. Our primary focus is on the discovery, development, and commercialization of groundbreaking therapies for patients suffering from severe,...

Company Overview:Ironwood Pharmaceuticals is a prominent player in the gastrointestinal (GI) healthcare sector, dedicated to enhancing the treatment landscape for GI disorders and setting new benchmarks in patient care. Our focus lies in the discovery, development, and commercialization of groundbreaking therapies for patients suffering from severe, rare...

Job Summary:The Senior Quality Assurance Specialist will provide quality support to Vertex's manufacturing operations, analytical laboratory operations, and materials management for external manufacturing programs. This role will review batch data, including batch records, deviations, in-process data, EM data, QC release testing, and other quality systems...

About the RolePlanet Pharma is seeking a highly skilled Data Architecture Lead to join our Business Information Systems (BIS) team. This role will focus on developing and maintaining a customer-centric data architecture that aligns with our guiding principle of 'Data is an asset.'Key ResponsibilitiesDevelop and execute a comprehensive data architecture...

About the RoleWe are seeking a highly skilled Data Architecture Lead to join our Business Information Systems (BIS) team at Planet Pharma. As a key member of our organization, you will be responsible for developing and maintaining a customer-centric data architecture that aligns with our guiding principle of 'Data is an asset.'Key ResponsibilitiesDevelop and...

Job OverviewLaboratory Operations Supervisor - Innovative BiotechRPM ReSearch is poised for expansion and is seeking a skilled Laboratory Operations Supervisor with a strong background in managing laboratory and facility operations within a startup environment.Key ResponsibilitiesOversee all laboratory functions, including waste management, gas exchange...

Job OverviewLaboratory Operations Supervisor - Innovative BiotechRPM ReSearch is poised for significant expansion and is seeking a skilled Laboratory Operations Supervisor with a strong background in managing laboratory environments and facilities within a startup context.Key ResponsibilitiesOversee all laboratory functions, including waste management, gas...

Job Title: GxP Data and CSV Engineer for mAlert ProgramJob Type: ContractLocation: RemoteJob Overview:We are seeking a highly skilled and detail-oriented CSV Document Author & Integration Specialist to join our team on a contract basis. The primary responsibilities of this role include authoring CSV documents for the mAlert program, building program...

As Front Office Manager you will lead our innovative TEAM in delivering upscale guest service, and creating memorable guest experience. This is an amazing opportunity to be part of both a dynamic TEAM, and grow your career in a leadership role. TEAM Culture:Our TEAM culture motivates and encourages each individual member to achieve "MORE" in daily life and...

About the Role:Takeda is a leading pharmaceutical company that is committed to delivering innovative therapies to patients worldwide. We are seeking a highly skilled and experienced Senior Manager to join our team in Cambridge, MA.Key Responsibilities:Develop and implement strategies for the lifecycle management of clinical bioanalytical and biomarker...

Principal Scientist, Preclinical PharmacologyPosition SummaryPepGen is seeking a highly motivated and innovative Principal Scientist to join the Preclinical Research and Development group in Boston, Massachusetts. We are looking for a senior scientist who brings enthusiasm, curiosity, scientific rigor, and a desire to transform the future of neuromuscular...

Job DescriptionGeneral/Position SummaryThe Quality Specialist is recognized as an expert internally in the principles and application of quality assurance and compliance. The Quality Specialist coordinates GMP activities in support of clinical and commercial Drug Product disposition. This position reports to Manager GMP Quality - Cell & GeneThe quality role...

The OrganizationWhat's happening at Entrada Therapeutics? Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible.Our Endosomal Escape Vehicle (EEVTM)-therapeutics are designed to enable the efficient...

Job DescriptionGeneral Summary:The Director, GxP SOPs and Training - Process Excellence, will be a key contributor in the GxP Process Operation Center (GPOC) and have overall responsibility for driving improvements to processes, systems, and governance around GxP procedures and training/education.This role is primarily responsible for transforming GxP...

Job DescriptionGeneral Summary:The Director, GxP SOPs and Training - Process Excellence, will be a key contributor in the GxP Process Operation Center (GPOC) and have overall responsibility for driving improvements to processes, systems, and governance around GxP procedures and training/education.This role is primarily responsible for transforming GxP...

Responsibilities: Should have solid validation lead experience working for pharmaceutical companies as Val lead/SME. Should have Validation Lead and LIMS advisory experience to guide the entire program/project teams. Should have great communication and coordination skills between internal team and customers across shores. Should have great stakeholder...

Job DescriptionGeneral Summary:The Associate Director, Vendor Quality Management is responsible for proactively and comprehensively monitoring vendor quality and compliance risk for vendors participating in GxP regulated environments across product modalities. This position is responsible for developing, maintaining, and disseminating vendor data and...

Job DescriptionGeneral Summary:The Associate Director, CMC Compliance is responsible for proactively and comprehensively monitoring vendor quality and compliance risk for vendors participating in GxP regulated environments across product modalities. This position is responsible for developing, maintaining, and disseminating vendor data and analytics,...

Job Description General Summary: The Associate Director, CMC Compliance is responsible for proactively and comprehensively monitoring vendor quality and compliance risk for vendors participating in GxP regulated environments across product modalities. This position is responsible for developing, maintaining, and disseminating vendor data and analytics,...

Job DescriptionPOSITION SUMMARY:The Associate Director, Information Systems Management entails providing risk-based oversight to Computerized Systems Life Cycle activities across a broad spectrum of technologies ranging from Automated Systems to Enterprise Wide systems and Software-as-a-Service (SaaS) solutions. This role ensures risk-based, overall...

Position Overview:The Lead Manager of Quality Assurance and Training will play a pivotal role within the GxP Process Operation Center (GPOC), taking charge of driving and/or supporting strategic initiatives while establishing the Quality Project Lifecycle and Change Management framework within our Quality division. This position will report to the...

Job DescriptionGENERAL POSITION SUMMARY:The Director, Global Quality Systems, provides strategic leadership and direction in the design, oversight of execution and effectiveness of the Vertex Quality Management System (QMS). In collaboration with quality and business partners, the position will be responsible for operationalizing an effective, efficient,...

DPS is looking for a Reliability Engineer to support a client in Boston, MA. ResponsibilitiesThe GxP Reliability Engineer will provide reliability engineering support for all facilities, utilities systems and equipment including analytical instrumentation, R&D lab support equipment and GMP systems for the manufacture of small molecule, large molecule and...

DPS is looking for a Reliability Engineer to support a client in Boston, MA. ResponsibilitiesThe GxP Reliability Engineer will provide reliability engineering support for all facilities, utilities systems and equipment including analytical instrumentation, R&D lab support equipment and GMP systems for the manufacture of small molecule, large molecule and...

Location: Boston,MA (Hybrid / Onsite)Therapeutic Area: Small molecule PharmaJob Overview: The role requires leading the development, design, and maintenance of the Quality System to ensure efficiency, effectiveness, and compliance with quality regulations and standards, reporting to the Head of Quality Assurance.Primary Job Responsibilities:Ensure compliance...

Location: Boston,MA (Hybrid / Onsite)Therapeutic Area: Small molecule PharmaJob Overview: The role requires leading the development, design, and maintenance of the Quality System to ensure efficiency, effectiveness, and compliance with quality regulations and standards, reporting to the Head of Quality Assurance.Primary Job Responsibilities:Ensure compliance...

RBW is partnering with an innovative biopharma company in its search for a Director of Quality. Our client has several biologics products on the market, with a strong development pipeline and is providing the right candidate with the opportunity to work with a rapidly growing organisation.The candidate will report directly to the executive team, and this...

RBW is partnering with an innovative biopharma company in its search for a Director of Quality. Our client has several biologics products on the market, with a strong development pipeline and is providing the right candidate with the opportunity to work with a rapidly growing organisation.The candidate will report directly to the executive team, and this...

Job DescriptionJob DescriptionThe CompanyVerve is a clinical-stage genetic medicines company established with a mission to solve the global health epidemic of cardiovascular disease. Founded by world-leading experts in cardiovascular medicine, human genetics and gene-editing, Verve is pioneering a new approach to the care of cardiovascular disease,...

Description: The IT Support Engineer plays an integral role in maintaining operations of our IT services and productivity of our end users. The IT Support Engineer will be actively involved in both daily operations as well as project related work. Daily operations will entail coordination and execution of technical support services for users of the...

Job Description General Summary: The Associate Director, Lab Computing Service Management will be a key technical resource in ensuring the planning and delivery of lab operations services for a wide range of commercial-off-the-shelf (COTS) and custom solutions in support of their business partners. This role will partner with DTE and business leadership to...

Job SummaryVertex Pharmaceuticals is seeking a highly skilled Senior Vendor Quality Specialist to join our team. As a key member of our Vendor Quality Management team, you will be responsible for providing coordination and support of Vendor Quality Management processes within CMC Quality.Key ResponsibilitiesSupport Vendor Quality Management Roadmap...

The Position Reporting to the Associate Director, Clinical Supplies & Logistics, the Manager/Sr. Manager, Logistics Contractor, will be responsible for providing global logistical support for the end-to-end supply chain for gene editing programs, coordinating movement of raw materials, drug substance, drug product, and equipment in support of manufacturing...