- Sartorius (CA)
- …perspectives. + Practical experience in pilot and production-scale process development . + Strong knowledge of cGMP bioprocessing operations and regulatory ... Sartorius is seeking a driven and collaborative Platform Development Specialist - Gene Therapy to...Minimum 2 years of hands-on experience in gene therapy process development or production. + Deep understanding… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …timely completion of associated operations/documentation, and assisting in the monitoring of cGMP compliance. As a Principal External Manufacturing Specialist , a ... manufacturers or business partners. + Leads a sub-team in continuous process improvements, system/equipment implementation and/or strategy development . +… more
- Kelly Services (Irvine, CA)
- We are seeking to identify a skilled **QA Validation Specialist (Contract)** to join a leading pharmaceutical team supporting critical ** cGMP qualification and ... in regulated environments and enjoy driving projects from protocol development through audit-ready execution. **RESPONSIBILITIES:** + Assists in assuring facility,… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …+ May manage direct reports and/or lead a sub-team in continuous process improvements, system/equipment implementation and/or strategy development . + You have ... Regeneron is currently looking for a Principal External Manufacturing (EM) Specialist to join the Advanced Therapies External Manufacturing Team that specializes in… more
- Kelly Services (Winston Salem, NC)
- …with incoming material qualification testing and lot release evaluations. + Support process development , validation activities, and data collection for ... **Manufacturing Specialist III - Cell Processing** **Location: Winston Salem...processing techniques, procedures, and regulatory compliance. + Drive continuous process improvement, incident investigations, and deviation resolutions. + Ensure… more
- Bristol Myers Squibb (Indianapolis, IN)
- …with RayzeBio policies, standards, procedures and global current Good Manufacturing Practice ( cGMP ). The Senior Specialist provides Quality support and oversight ... aims to be the global leader in radiopharmaceuticals. **Summary** The Senior Specialist , QA Operations will help support operations through quality oversight in a… more
- Herbalife (Lake Forest, CA)
- …that ensures each teammate gains a holistic understanding of the development process through commercialization. **Qualifications** SKILLS AND BACKGROUND REQUIRED ... Specialist , Document (Technical Operations) Category: Manufacturing Position Type:...to ensure manufacturing batch records encompass all compliance and process requirements. **HOW YOU WOULD CONTRIBUTE:** + Prepare and… more
- Bristol Myers Squibb (Indianapolis, IN)
- …with RayzeBio policies, standards, procedures and global current Good Manufacturing Practice ( cGMP ). The Senior Specialist provides Quality support and oversight ... to be the global leader in radiopharmaceuticals. **Summary** The Senior Specialist , External Manufacturing Quality Assurance is responsible for quality oversight of… more
- ThermoFisher Scientific (Pittsburgh, PA)
- …the opportunity for continual growth and learning in a culture that empowers your development . With revenues of more than $40 billion and the largest investment in ... HMD; Pittsburgh, PA **Discover Impactful Work:** As a Supplier Quality Operations Specialist , you'll ensure SKU accuracy and product quality by working with… more
- ADM (Forsyth, MO)
- …during shift. + Works with necessary groups to resolve outstanding issues with process documents / logbooks, cGMP walk through inspection observations and ... **103915BR** **Job Title:** Quality Assurance Specialist - Forsyth, MO **Department/Function:** Operations: Manufacturing, Production, Maintenance, Utilities **Job… more
- Takeda Pharmaceuticals (Los Angeles, CA)
- By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application ... Micro projects. This role involves equipment qualification, partnership in the development of and validation of Microbiology methodologies, analyzing complex data,… more
- Genentech (Hillsboro, OR)
- …improvement and excellence. **The Opportunity** As an Environmental/Sterility Quality Assurance (EQA) Specialist , you will play a pivotal role in shaping and driving ... and approval of CCS and sterility assurance-related systems, ensuring alignment with cGMP , ATMP GMPs, USP, EP, and JP standards. + Collaborate with manufacturing,… more
- Catalent Pharma Solutions (Kansas City, MO)
- **Senior Validation Specialist I, BioAnalytics Computer System Validation (CSV) & Compliance** **Position Summary:** Catalent, Inc. is a leading global contract ... development and manufacturing organization (CDMO) whose mission is to...Kansas City, MO (KCM) is hiring a Senior Validation Specialist I, BioAnalytics CSV & Compliance. The Senior Validation… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Sr Specialist will be responsible for the ideation, planning, development oversight for the Biologics Clinical Manufacturing business capability. Participates in ... member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we… more
- Catalent Pharma Solutions (Chelsea, MA)
- **Quality Assurance Specialist II, Operations (Night shift, on-site)** **Position Summary:** + **Work Schedule:** Night shift 7-day rotating 12-hour shift with hours ... (Chelsea, MA) Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO), and the Boston-area facility...SD1, SD4 and SD7, the latter being the largest CGMP unit of its kind for DPI in North… more
- Charles River Laboratories (Wilmington, MA)
- …70 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, ... resume/CV must be uploaded and submitted during the application process . Please make sure work history and education are...**Job Summary** We are seeking an Instrument Field Support Specialist for our Endosafe instruments: nexgen MCS, nexgen PTS,… more
- Merck (De Soto, KS)
- …product fill-finish. The BTS-SS team is also responsible for supporting the BTS Process Development (PD) team during new process /product introductions. ... departments (eg Quality, Research, Production, BTS - Analytical and /or Process Development ), must ensure sound scientific data/literature/evaluation and… more
- Merck (Durham, NC)
- …Skills:** Accountability, Accountability, Adaptability, Capital Project Management, cGMP Regulations, Change Management, Communication, Curriculum Development ... troubleshooting. This individual will provide input to the deviation investigation process for determination of root cause, recommend corrective actions to prevent… more
- Sumitomo Pharma (Morrisville, NC)
- …to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on ... and experienced individual for the position of **Quality Assurance Specialist II** reporting to the Senior Manager Quality Assurance...includes weekends on a rotating basis, as the manufacturing process is a 7-day process . This role… more
- Genentech (South San Francisco, CA)
- …Genentech Research and Early Development on the South San Francisco campus. The specialist will be a member of the SMAC Equipment and GMP Operations Group. This ... **The Opportunity** We are seeking a motivated and experienced Quality Assurance Specialist to join the Synthetic Molecule Analytical Chemistry (SMAC) department in… more
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