Responsibilities: Lead development and implementation of the GCP supplier audit and compliance strategy for clinical development programs, GMA and MPG studies. Serve as primary point person for key GCP strategic partners; lead key suppli...
Responsibilities: Establish strong scientific and technical initiatives and hands-on implementation for new in vitro models. Execution of in vitro experiments to create cellular models in immortalized cell lines, primary neurons and/or i...
Responsibilities: Facilitate holistic data integrity reviews by partnering with QA and stakeholders to conduct end-to-end business processes assessments. Prioritize gaps and risks and provide oversight to needed remediation activities. ...
Responsibilities: Authoring and reviewing of SOP's (both new and existing). Authoring and reviewing Equipment Requirements Specifications. Document calibration and maintenance requirements, generate procedures. Supporting Equipment Man...
Responsibilities: Request and handle human and monkey donor blood samples. Isolate primary cells from peripheral blood using sterile techniques. Set up, maintain, and monitor cell cultures with isolated blood cells. Perform cell stimul...
Responsibilities: Establish strong scientific and technical initiatives and hands-on implementation for new in vitro models. Execution of in vitro experiments to create cellular models in immortalized cell lines, primary neurons and/or i...
Responsibilities: Monitor compliance with GMP, FDA, and regulatory requirements throughout manufacturing. Conduct inspections, audits, and testing to ensure products meet quality standards. Review batch records, documentation, and proce...
Responsibilities: Draft and implement Quality System documentation designed to establish good validation practices within the organization. Author URS, IQ, OQ and PQ protocols and execute them in compliance with GDP guidelines and intern...
Responsibilities: Software/AI experience. Strong knowledge of FDA and EU regulatory requirements, specifically with QMS. Experience with CAPA processes, document management, and regulatory submissions. Familiarity with cybersecurity...
Responsibilities: Developed and optimized efficient, cost-effective, and validated manufacturing processes for medical devices, focusing on capital and/or disposable devices, including assembly, lot release testing, sterilization, and pac...
Roles & Responsibilities: Bachelor of Science in Lifesciences or master's Preferred. 3-5-year experience level. In vitro primary cell culture (human PBMC, Cyno PBMC and mouse splenocyte). Serial dilutions of drug molecules and applicat...
Responsibilities: Lead the strategic efforts in the interpretation of relevant and new quality guidelines to ensure that the current and phase appropriate requirements and standards are properly and timely implemented. Provide support to...
Roles and responsibilities: Computer System Validation (CSV) with 10+ years of experience in patient safety and regulatory compliance. Drive critical projects in Patient Safety, Commercial, and Medical Affairs, ensuring audit readin...
Responsibilities: Client Protocol Execution: Independently execute Airflow Pattern Studies (Client) to ensure compliance with GMPand regulatory requirements. Revise, update, and maintain Client protocols and associated documentation, as ...
Responsibilities: Processes, proofreads, verifies and manages various clinical regulatory documents, ensuring they are submission-ready for publishing with an appropriate level of accuracy and consistency. Communicates regularly with col...
Overview: The Genomics Research Canter (GRC) is a centre of excellence for genetics and genomics that supports both Discovery and Development. The GRC plays an integral role towards our goal of developing extraordinary genetics and genom...
Responsibilities: Strong Windows Desktop Support Experience. Hands-on experience in handling the Parma LAB devices and instruments. Desktop Hardware and troubleshooting at L2 + (Window 10, 7). Experience in handling IT Desktop ...
Responsibilities: The role requires strong US, EU, China, and international regulatory experience that can be leveraged to help support international expansion. This is a hybrid role (in office 3 days per week) based in Marlborough, MA. ...
Roles & Responsibilities: The ideal candidate will have 7-8 years of validation experience and at least 3 in Salesforce Validation. Seeking a CSV resource who has experience specifically with Salesforce. They are currently seeking a Sr....
Responsibilities: He/she is expected to have the potential to be the analytics lead for the assigned therapeutic area (TA) to mitigate, resolve and triage certain issues and reduce the touch point needed from the study lead. Responsibili...