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Minimum of five years of progressive experience in a clinical laboratory or GMP Cell Therapy Lab, and a minimum of three years of teaching experience in an accredited program. The Cell Therapy GXP Educational Program Director is a key leadership position that will develop and implement the Cell Therapy GXP Workforce Training Program (WTP) within Dana-Farber Cancer Institute.
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The VP QA will direct all GxP Quality activities and ensures Aveo and its vendors are inspection ready, adhere to GLP, GCP, GPV, GDP and GMP applicable regulations, company policies & procedures.
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Providing oversight of GMP systems completed by CMO's and External Supply Chain function related to Drug Substance, Drug Product and Finished Product. Minimum of 5 years' GMP related experience in biopharmaceutical / pharmaceutical or related industry.
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The Project Manager, VCGT LIMS Deployment, is required to have relevant PMO-related experience specifically in LIMS implementation in a pharmaceutical GMP environment. The Project Manager for LIMS is a role within the Technology Program Management Office reporting directly to the Senior Director, DTE Portfolio Manager, with dotted line matrixed reporting to the Director, Business Engagement & Technology.
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The Senior QA Specialist, Global Product Quality implements and maintains the quality systems and tools required to manage and monitor the quality and compliance of GMP vendors that are utilized in the manufacturing, packaging, testing and distribution of Cerevel products.
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Creates and enforces safe work practices Develops and administers department pay plans and budgets Qualifications: Strong knowledge of SMT processes, equipment, and industry best practices Working knowledge of basic printed circuit board design and concepts Working knowledge of GMP and ISO requirements.
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Perform tasks in a manner consistent with the safety policies, quality systems, and GMP requirements. Prepare kitting packages for assembly production. Developing experience in domestic and international shipping of cold chain products in the Biotech/Lifesciences industry and its associated documentation.
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Azzur COD is looking for a GMP Facility Manager. GMP experience in preferred. Including HVAC, Gases, Liquid Nitrogen, Tower Water, Heating Hot Water, Refrigerated Water, Etc. This employee will be a Cleanrooms On-Demand Burlington business unit (Facility Solutions) leader, who will be responsible for employees supporting the facility, client start-up, and continuous business improvement at COD. The Facility Manager will perform repairs, Maintenance, and improvement within cGMP cleanrooms, Laboratory, Warehouse, and office spaces.
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Experience in quality control roles supporting GMP testing and manufacturing of gene therapy or gene editing products (i.e., ATMPs or equivalent). Our client is looking for a Quality Control Lead who will be responsible for implementing compendia and total organic carbon methods for internal GMP testing.
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Experience in Quality Control roles supporting GMP testing/manufacturing of gene therapy or gene editing products, ATMPs or equivalent. The Quality Control Lead will be responsible for implementing compendia and total organic carbon methods for internal GMP testing at Tessera.
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Work in a clean room environment while fully gowned following GMP guidelines and using aseptic technique. BS in Biology-related field of study with minimum 1 - 2 years of experience in a GMP environment.
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Represent the analytical development function for authoring, reviewing, and approval of GMP and regulatory documents as appropriate, including SOPs, protocols, reports, specifications, QTPPs, CQAs, risk and impact assessment, and filing sections.
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The incumbent will perform all the following as a member of an interdisciplinary team, inclusive of a cyclotron engineer, radiochemists, GMP production staff, and nuclear pharmacists. Perform routine manufacturing processes in support of PET GMP production runs.
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Must adhere rigidly to all GMP policies and procedures as stipulated by the FDA. Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program.
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Must be knowledgeable of FACT, FDA (GMP/GTP regulations, etc), AABB, JC, CLIA, OSHA and Massachusetts DPH regulations. The Quality Assurance Director will provide the Cell Manipulation Core Facility with direction and leadership in the development, implementation and auditing of Quality programs to support regulatory and accreditation compliance with applicable requirements (GMP/GTP/FACT/JC and other industry standards) as well as federal and state laws, and ensure that clinical and laboratory operations meet the highest quality standards set by the organization.
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