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Analyze and articulate customer and market needs, prospect all categories of gene therapy accounts from discovery to CDMO, develop relationships with customers and drive / manage opportunities in collaboration with the sales organization to meet and exceed sales goals.
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Familiarity with regulatory requirements and standards, such as FDA, GMP, and ISA. Certification in DeltaV or related control systems. Familiarity with regulatory requirements and standards, such as FDA, GMP, and ISA. Certification in DeltaV or related control systems.
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Can streamline research by delivering operational and cost efficiencies through the strategic insourcing of GMP, GLP and non-GLP research services from discovery through safety assessment. We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development.
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BS or BA degree in Science or Engineering with 5-10 years of GMP experience with at least one year in an FDA regulated industry. The QA Specialist I, Batch Release is responsible for performing duties related to the management of records relevant to the review and release of Batch Records for the CGMP operation of Emergent BioSolutions in Baltimore Camden Site. Our QA Department provides expertise in problem solving and process improvements.
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This position must comply with all Quality, GMP, ISO and safety regulations and adheres to company travel policies. The Field Service Engineer reports to the District Service Manager, and works directly with the district team Leads to acquire formal instrument training and field based OJT for certification on BD products.
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Piper Health Sciences is seeking a QA Document Control Specialist to join a clinical-stage biotech company located in Elkridge, MD. The QA Document Control Specialist will be responsible for filing and archiving GMP documents.
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The Transportation Manager plays a pivotal role in overseeing all aspects of Transportation Operations for the plant, ensuring strict compliance with DOT, environmental, and GMP policies and procedures.
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Abides by Niagara's Good Manufacturing Practices (GMP) and Food Safety Standards at all times. Employment agencies that have fee agreements with Niagara Bottling, LLC and have been engaged on a search shall submit résumé to the designated Niagara Bottling, LLC recruiter or, upon authorization, submit résumé into this career site to be eligible for placement fees.
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GDP. GMP etc) Regularly review and reporting on compliance conducted with precision and attention to detail, ensuring that all information is accurately documented and shared with the quality control, quality assurance and manufacturing department.
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The ideal candidate will be responsible for overseeing all aspects of manufacturing engineering activities, ensuring efficient production processes, implementing TPM methodologies, and maintaining compliance with GMP (Good Manufacturing Practices) standards in our facility.
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Experience within cell and gene therapy strongly preferred. Help build the mRNA and Cell Therapy sales process and record information in Salesforce (SFDC) database to enable both peers and commercial leadership across the greater Thermo Fisher network to communicate and succeed.
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Experience in GMP regulated environment. Verifying system drawings including ability to review and as built P&IDs (piping and instrumentation drawings) and I&C (instrumentation and controls) drawings as well as verifying electrical schematics with support of an electrical engineer.
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The majority of our projects would be considered Construction Manager type with a GMP or Design Build. Our services now encompass general construction, furnishing and installation of architectural millwork, commissioning, joint ventures, diversity partnerships, construction management, historic wood restoration, plastic laminate, doors, frames, hardware, laboratory casework and miscellaneous specialties.
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Will be responsible for filing and archiving GMP documents. 2-5 years of experience in a GMP environment. QA Document Control Specialist. Previous document control experience, handling batch records, and performing batch record reviews.
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We're seeking an experienced Team Leader to head our batch record review team at the Cell & Gene Manufacturing facility in Maryland. Experience in Cell & Gene Therapy. Oversee the review of batch records for completeness and compliance with SOPs, GMP guidelines, and regulatory requirements.
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