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Support commissioning and startup activity of new process control systems and manufacturing systems (Syncade, DeltaV, PLC’s, OSI PI historian, etc). The successful candidate will be:Site Owner of “IT OT Infrastructure” for Manufacturing System Platforms including Syncade MES, DeltaV Distributed Control System, PLC's, Lab Data Systems (Smartline Data Cockpit.
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Author protocols, technical summary reports/memos and tech transfer documentation defining the manufacturing process and parameters. Previous experience interfacing with biologics drug product manufacturing sites and providing technical support during engineering runs/GMP operations is a plus.
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Review Master Batch Records for accuracy and trend process data supporting process development or fill/finish manufacturing operations. Execute studies in support of drug product technology transfers to clinical and commercial manufacturing sites.
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BDPD is responsible to develop and characterize formulations and processes for all biologic drug products in pivotal (P3) and commercial stages; also responsible for short / long term stability assessments, technology transfers to clinical and commercial sites, manufacturing support, in-use and compatibility to support clinical studies.
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Good understanding / experience in biologics drug product process (freeze-thaw, filtration, mixing, filling, lyophilization) Protein formulation/stability of various dosage forms (liquid/lyophilized) employing a variety of biochemical and biophysical analytical techniques, such as HPLC, capillary electrophoresis, and/or spectroscopy methods, analytical data analysis.
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A basic understanding of formulation and drug product process development for biologics (antibodies, fusion proteins, bi-specifics, vaccines, antibody drug conjugates, etc. o Protein formulation/stability of various dosage forms (liquid/lyophilized) and configurations (vial/syringe), employing a variety of biochemical and biophysical analytical techniques, such as HPLC, capillary electrophoresis, and/or spectroscopy methods.
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Experience with some scale-down/-up of biologics drug product process development activities; buffer preparations, testing using compendial methods (osmo, protein conc., pH, etc.) Title : Senior Research Associate - Biologics Drug Product Development (BDPD.
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Role: Senior Research Associate - Biologics Drug Product Development (BDPD). A minimum of 5+ years of experience with BS degree or 3+ years of experience with MS degree in Pharmaceutical Sciences, Biology, Biochemistry, Biochemical Engineering or a related scientific discipline.
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Job Title: Senior Research Associate - Biologics Drug Product Development (BDPD) Seeking motivated, team-oriented individuals with scientific experience in laboratory work related to biologics. Experience working with Biologics molecules (proteins, mAbs); experience working with Client is a plus.
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Team Size - 11 full time employees; approx 20 total in pivotal Biologics DP function. o Scale-down/-up of biologics drug product processes. Be self-motivated, organized, thrive in team settings and enProduct scientific investigation and thinking, as well as be familiar with the relevant technical literature.
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Founded in 2004, Pharmaron has invested in its people and facilities, and established a broad spectrum of research, development and manufacturing service capabilities throughout the entire drug discovery, preclinical and clinical development process across multiple therapeutic modalities, including small molecules, biologics and Cell & Gene Therapy products.
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Continuous innovation in passive component function integration, miniaturization, and manufacturing automation, cutting edge WSS and amplify technology and comprehensive optical, mechanical, electrical and software integration capabilities enable us to serve the needs of high-density, high-bandwidth, and flexible optical networks.
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Successful Technical Run for Process Equipment completion Primary Responsibilities: Interfacing with highly automated production systems and controls in cGMP manufacturing environment Assemble prepare and operate equipment for manufacturing operations including cell culture or purification e.g. culture growth process monitoring sampling harvesting purification formulation freeze thaw and transfer.
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Responsible for short / long term stability assessments, technology transfers to clinical and commercial sites, manufacturing support, in-use, and compatibility to support clinical studies. Basic understanding of formulation and drug product process development for biologics (antibodies, fusion proteins, bi-specifics, vaccines, antibody drug conjugates, etc.
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Including Gdp, Java (Programming Language), Knowledge Of Capa, Knowledge Of Gmp, Kubernetes, Managing Performance Improvement, Manufacturing Production, Mathematical Optimization, Project Commissioning, Project Engineering, Project Execution, Reactjs, Risk Management, Root Cause Analysis (RCA), Scheduler {+ 2 more.
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manufacturing job Title: manufacturing assistant Company: Autodesk in Vista, CA
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