61 to 75 of 90
Responsible for oversight, coordination, and execution of clinical trials in support of the oncology program in Phases I IV of development Duties and Responsibilities Clinical project team member works closely with the Clinical Program Manager and is responsible for oversight, planning, and execution of assigned clinical studies, timelines, and key deliverables. Works clo
Posted 28 days ago
Observe manufacturing operations in an aseptic environment. Communication of identified non conformances. Review of manufacturing batch records, executed validation review, Maximo WO's, and logbooks. Write or revise SOPs, forms, and deviations. Follow up on preventive and corrective actions associated with deviations. Effective communication with major connections, co wor
Posted 28 days ago
Alkermes, Inc. is the U.S. operating company of Alkermes plc, a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to research, develop and commercialize, both with partners and on its own, pharmaceutical products that are designed to address unmet medical needs of patients in major therapeutic areas. Alke
Posted 28 days ago
The Associate Director/Director of Biostatistics will support drug development activities and decision making encompassing Phase I IV studies, biomarker analyses, Real World Evidence data and research. This includes expert guidance on innovative clinical study designs and analyses, modeling and simulation, and non clinical statistics. Duties and Responsibilities Work with
Posted 28 days ago
The position will perform QA work responsibilities in support of manufacturing and facility operations, including quality systems and projects. Functions include proactive support of change control assessments, documentation reviews, discrepancy identification and resolution on the floor. Key Duties Ensures compliance to internal procedures, policies, and standards, as we
Posted 28 days ago
Aligns enterprise architecture direction and solutions with business strategies Designs and delivers solutions that align with enterprise architecture standards and advances the architecture toward the target state Verify technology standards and best practices are maintained across the organization. Identifies the enterprise business drivers and requirements that advance
Posted 28 days ago
The Director, Head of Functional Genomics will set the strategy of enabling and deploying state of the art sequencing technologies in the burgeoning field of multiomics. The role oversees our efforts to generate and leverage bulk and single cell sequencing data to better understand CNS and immune oncology diseases. The successful candidate has a strong track record in des
Posted 28 days ago
The Senior Clinical Data Analytics Associate is responsible for supporting the clinical development operations (CDO) group by identifying, creating and maintaining technological solutions and data visualizations to enhance clinical trial operations and management. The Senior Clinical Data Analytics Associate will participate in the review and/or implementation of new tech
Posted 28 days ago
Responsible for leading and mentoring the Clinical Data Management, Clinical Data Standards and Governance, and Clinical Data Sciences teams. Responsible for teams who design, test, and maintain, and grant access to all clinical data collection systems, following a Risk Based Monitoring (RBM) operational framework, generating impactful data insights and implementing effec
Posted 28 days ago
The position will perform QA work responsibilities in support of Quality Systems, including any projects. Key Duties Ensures compliance to internal procedures, policies, and standards, as well as all relevant State, Federal and International regulations during oversight of the operations. Approve complaints, change controls, deviations, CAPA, batch records, reports, proce
Posted 28 days ago
and deliverables may include but are not limited to Gather user requirements within the various business groups and assess technological needs Identify, investigate, and create PoCs (Proof of Concepts) around emerging and defined cloud technologies and collaboration services (e.g. SharePoint, Microsoft Teams) Support the execution of key deliverables on IT Infrastructure r
Posted 28 days ago
and deliverables may include but are not limited to Gather user requirements within the various business groups and assess technological needs Identify, investigate, and create PoCs (Proof of Concepts) around emerging and defined cloud technologies and services (e.g. Intune, SCCM, VDI) Support the execution of key deliverables on Desktop Engineering roadmap (data cleansing
Posted 28 days ago
The Formulation Development Group is seeking a person who will contribute directly to a team responsible for assessing developability of biotherapeutics with the goal of selecting development candidates. The role will include developing injectable dosage forms (liquid and lyophilized) in both pre clinical and clinical development. These activities will include (i) develop
Posted 28 days ago
The neurophysiology group within the Research and Development organization is searching for an experienced electrophysiologist to support novel drug discovery research in CNS disorders. Individuals with exceptional experience in in vitro/ex vivo electrophysiology are encouraged to apply. This position will be part of a larger multidisciplinary team challenged with interro
Posted 28 days ago
include but are not limited to Lead the PAT group at the Waltham site and build expertise and capabilities to support implementation in early and late stage phase development. Lead the cross functional global PAT SME group to oversee PAT implementation. Develop, qualify and validate on line, in line, and at line PAT methods to deliver drug substances and drug products of d
Posted 28 days ago
Email this Job to Yourself or a Friend
Indicates required fields