Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety... such as method validation/verification and method transfer Be accountable for the success of ALCM projects/activities and ensure...
Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety... for assay results. Establish reference standard materials as required to support assay validation. Establish a critical...
transfer and validation, impurities, mutagenic impurities, etc. Strong knowledge of GLP and GMP requirements... and their application in a phase appropriate manner Experience in technical transfer for non-GMP and GMP production and testing to external...
Work Schedule Second Shift (Afternoons) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP... instrumentation is procured and maintained to GMP standards Maintain inventory of lab consumables, reagents, reference standards...
aim of generating data packages to successfully transfer technology into GMP pilot plant and manufacturing sites... and undergo successful process validation is a must. This individual may be responsible for the professional development...
across three main areas: a) Characterization and in vitro comparability, b) Method development and validation of methods... testing applications). Knowledge of complex and state-of-the-art methodology for biologics GMP method development...
required for GMP compliance and perform experiments to validate the changes. Author and execute qualification and validation protocols... and engineer them towards robust deployment and implementation in GMP. POSITION ACCOUNTABILITIES: Support process...
, testing, control, validation, and release of drug substance and drug product for commercial and clinical distribution... documents (i.e. specifications, batch records, tech transfer/validation protocols, etc.) Support stability program strategy...
of validation documentation and scan all documents in need of upload to the server. Maintain and oversee Quality controlled records... to regulatory compliance knowledge including GMP, ISO 13485, ISO 15189, CAP/CLIA, NYS, states, GCP, IVDR, and 21 CFR Part 11...
, EMA, etc.) and industry standards (GMP, GxP). Prepare and review validation documentation, including Validation Master..., Qualification, and Validation (CQV) to our esteemed clients. We are committed to delivering exceptional service and expertise...
strategy and framework for the organization, focusing on a cloud-first, secure, GMP-compliant approach Oversee and lead... regulations (e.g. FDA 21 CFR Part 11, GMP, GxP) Implement technical solutions, tools, and process improvement strategies...
Work Schedule First Shift (Days) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety..., dissolution, GC, KF, etc.), including method validation/transfer Experience with both drug substance and drug product (oral solid...
(s) during GMP inspections Work within a cross-functional team to coordinate and prepare high quality, timely correspondence and CMC..., method or process validation protocols and reports, specifications, technical assessments, etc.) Provide input on project...
-7 years of relevant industry experience is required. Proven experience in analytical method development and validation... products or stem cell technologies. Knowledge of GMP or GLP regulations in a laboratory setting. Experience in training...
in collaboration with process development colleagues and GMP team. Key Responsibilities: Autonomously design, execute, and analyze...&D, GMP teams, etc., in an agile and open way ensuring good communication and alignment. Drive innovative solutions and meet...
environment and building products according to Industry Standards, including US FDA GMP/GLP, ISO13485, CE, and other regional... concept, prototyping, drafting, assembly, component qualification and testing (including verification and validation...
from pre-clinical through validation and commercialization. These activities will be accomplished by planning and managing.... Responsibilities and Duties Oversee process development, validation and production activities at contract manufacturers of drug...
to CMOs and manage change controls, manufacturing batch record development, IPC, troubleshooting Lead scale-up and validation...) a plus Strong knowledge of QbD approaches to drug product development Documented experience working in a GMP environment Proven leadership...
successful candidate must have hands-on background in development and GMP implementation of recovery and purification operations; spanning..., including (but not limited to): study protocols and reports, validation documents, SOPs, regulatory submissions, and test...
controlled GMP warehouse as well as fully-staffed Manufacturing Technical Services, Validation, Facility Operations, Engineering... Pharm Sci Leadership Team and other stakeholder functions such as GMP quality, Regulatory, Program & Portfolio Management...