R & D Jobs in Lexington, Massachusetts
249 Lexington, MA R & D jobs found on Monster.
G R Validation & Compliance Services, Inc. is a full service Validation, GMP Compliance, Engineering, Equipment Design and consulting and staffing firm dedicated to serve the FDA regulated Pharmaceutical, Biotechnology and Medical Device industries. We are currently looking for Validation Engineers at multiple locations. Location: Boston, MA Validation Engineers: 6-12 months contract with a possib...
Primary Duties: Shire is seeking a multi-talented, highly motivated individual with broad experience conducting routine biological assays (western blots, ELISA, protein gels, agarose gels, enzyme activity, etc.) with comprehensive understanding is imperative for success. Candidate is expected to have full proficiency of molecular biology with a strong focus on analytical detail. Experience in all...
Primary Duties: Shire is seeking a highly motivated, multi-talented individual with extensive experience involving all aspects of RNA (synthesis, extraction, isolation). Candidate is expected to have full proficiency of molecular biology with a strong ability to perform molecular cloning of genes, restriction digestion, ligation, etc. Ability to characterize (digestion, sequence) and troubleshoot...
Primary Duties: Shire is seeking a highly motivated, multi-talented individual with extensive experience involving all aspects of process development/CMC. A record of troubleshooting issues related to scale-up is necessary for success. The desired candidate must have experience managing multiple contract research organizations (CROs) while maintaining strict project timelines. Candidate is expecte...
Primary Role: The Discovery Medicine Director will serve a key role in providing solid clinical expertise to Shire HGT's early Drug Discovery and Translational Research programs in rare and orphan diseases. The primary focus of this role will be in the selection of disease indications and targets based on clinical need and alignment of these research programs through in vitro and in vivo proof-of-...
Primary Duties: This individual will be a key member of the Commercial Support group in Purification Process Development department and will be responsible for providing technical and scientific expertise on continuous process improvements and cGMP manufacturing technical support for multiple downstream purification processes of commercial products of Shire. Scope of work includes a variety of dow...
Primary Duties: This individual will be a key member of the cell culture bioengineering group and will be responsible for providing technical and scientific leadership to the development of cell culture processes. Scope of work includes cell expansion, bioreactor production and harvest clarification process development, optimization and characterization, bioreactor process scale-up and scale-down,...
Our lead drug candidate, ganetespib, is moving towards Phase 3 development in non-small cell lung cancer after showing impressive overall survival improvements in Phase 2. Responsibilities: · Responsible for leading all the formulation efforts for an early discovery intravenous drug platform. · Design and conduct experiments to evaluate pharmaceutical properties including solubility, stability, so...
Primary Duties: The primary responsibility of the Sr. R&D Compliance Specialist I will be to support the R&D Compliance & QA function by assuming full responsibility for specific tasks as outlined in the job description below: The Sr. R&D Compliance Specialist I will focus primarily on providing GCP/GLP Compliance support and guidance as needed to development teams. In addition, the Sr. R&D Compli...
Primary Duties: The Clinical Pharmacology and PK Senior Scientist will be responsible for providing pharmacokinetic (PK), and PK / pharmacodynamic (PD) modeling analysis and reporting expertise for multiple drug development programs from a variety of therapeutic areas spanning discovery/early development and continuing through late stage / post marketing clinical development. The individual will b...
Job Description Development Specialist Perform routine in-process testing including but not limited to, ELISA, titer assay, activity assay, Western Blot, binding assay and host cell protein assay. Contribute to improving the effectiveness, efficiency and customer service of the testing group. Analyze and document testing results. Summarize and report data. Experience with protein purification and...
Job Title: PV Associate Position Responsibilities Review the Triage incoming reports for initial assessment of seriousness, expectedness, causality, and reportability for reports from clinical trials and post marking sources in accordance with local work instructions, US FDA regulations, and international guidelines and regulations with high level of accuracy, accountability, and minimal supervisi...
Responsibilities: Review the Triage incoming reports for initial assessment of seriousness, expectedness, causality, and reportability for reports from clinical trials and post marking sources in accordance with local work instructions, US FDA regulations, and international guidelines and regulations with high level of accuracy, accountability, and minimal supervision Assist with data entry of inc...
Our client in Lexington, MA is looking for a Quality Assurance Contractor to perform a wide array of Quality Assurance activities focusing on quality compliance. Activities will be in support of commercial drug product (DP) manufacturing (including secondary packaging and labeling activities). Work closely with Contract Manufacturing Organizations (CMOs). Duties and Responsibility: Review manufact...
PointRight is the industry leader in providing data-driven analytics and decision support services to long term care facilities. We offer web-based analytic services that help facilities improve their compliance, financial, clinical and risk management goals. We are seeking a Senior Statisticianand Data Management Specialist to join our team and develop predictive models for PointRight’s Healthcar...
Company Confidential
Lexington, MA, 02420
Position Summary: The Senior Analyst, Decision Support will support the current and future success of our brands by providing analytical support (described below) with the goal of developing recommendations on Commercial strategies and tactics. Identify key business questions and testable hypotheses Analyze secondary data (e.g.: analysis of sales post entry of generic competitor using IMS sales da...
Clinical QA Auditor BS preferred; but not required Experience: 2-3 years doing Clinical QA Auditing; 5 years total Clinical/GCP industry experience * Clinical/GCP experience * Ability to interface w/ Clinical team on daily basis * Accurate record keeping, documentation and strong understanding of the Clinical/GCP atmosphere * Drug Safety experience (PLUS; but not required) Duties/Responsibilities:...
ImmunoGen, Inc. is in search of a highly motivated Research Associate to join our Bioanalytical Sciences group. The qualified candidate will be involved with enhancing two major duties which includes critical reagent preparation and characterizations as well as protein impurity assay and characterizations with a focus on host cell proteins. Primary Responsibilities: · Preparation of critical reage...
Position Summary: The successful candidate will provide strong technical knowledge in all aspects of MS and MS/MS in vitro diagnostics reagent product development. The development of reagents and methods for neonatal screening, clinical and general life sciences applications on MS, MS/MS and HPLC-MS/MS platforms. Key Responsibilities: · Design and execution of feasibility, verification and validat...
Company Overview TEI Biosciences is a fast-growing biomedical company developing, manufacturing, and marketing collagen-based biologic devices for the repair and reinforcement of soft tissues and for the management of wounds. In addition to product lines with major market partners, TEI currently markets and directly sells SurgiMend®, indicated for hernia repair and breast reconstruction and PriMat...
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