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- ...Gaithersburg, MD, seeks a regulatory and product development professional to support Master File submissions and regulatory communications for ATMPs and CGT products. The role requires a BS in a scientific field and at least 5 years in regulatory support, with strong technical...Suggested
$241k - $332k
About This Role:As the Head of Regulatory CMC - Biologics & Advanced Therapy Medicinal Products (ATMP), you will lead a dynamic team within the PO&T function, driving the regulatory strategy for biologics and ATMPs in Biogen’s portfolio. Your role encompasses global, regional...SuggestedFull timeTemporary workLocal area- ...things possible not only in your community, but around the world. HDR is providing PM/CM services for the Los Angeles World Airports ATMP Landside Improvements Project. The project will deliver critical improvements to the roadways, streets, and thoroughfares in and...SuggestedContract workTemporary workFor contractorsWork at officeLocal areaFlexible hoursNight shiftWeekend work
- ...Demonstrated success managing client relationships, SOW scope management, revenue targets, and multi-project service portfolios in the ATMP/CGT sector.Technical Breadth: Deep knowledge of process/analytical development, vector biomanufacturing, cell processing, and...SuggestedContract work
- ...things possible not only in your community, but around the world. HDR is providing PM/CM services for the Los Angeles World Airports ATMP Landside Improvements Project. The project will deliver critical improvements to the roadways, streets, and thoroughfares in and...SuggestedContract workTemporary workFor contractorsWork at office
$213.06k - $260.41k
...matrix environment and lead with curiosity and influence across functional and organizational linesExperience with IND or BLA filing of ATMP/biologic products.Experience with commercial QC activities#LI-HybridEEOC Statement: Intellia believes in a diverse environment, and...SuggestedFull timeRemote workShift work- ...on inventory strategy, yields and cost impacts on product P&L, forecasting, and cross-functional decision support across wafers and ATMP operations.THE PERSON: The ideal candidate should have a bias for action, high sense of teamwork, and ability to speak up and make recommendations...Suggested
- ...technical knowledge of aseptic processing and cell processing techniques, as well as applicable regulatory frameworks including cGMP and ATMP requirements and biosafety expectations.Support future expansion and site-readiness initiatives, including area readiness, equipment...SuggestedFull timeLocal areaImmediate start
- ...processes preferred.TECHNICAL SKILLS / CORE COMPETENCIESDeep expertise in GMP regulations applicable to QC laboratories supporting ATMPs.Strong knowledge of analytical techniques (e.g. q/rt/ddPCR, flow cytometry, ELISA, cell-based assays, microbiological methods) and their...Suggested
- ...manufacturing modality, such as: Monoclonal antibodies (mAbs) Fill-finish (aseptic or non-aseptic) Advanced therapy medicinal products (ATMPs), including cell and gene therapies mRNA Vaccines Active pharmaceutical ingredients (API) Oral solid dosage (OSD) Exposure to...SuggestedFor contractorsCasual workFlexible hours
- ...relevant experience is required.Required:· 2+ years of analytical control strategy experience on advanced therapy medicinal products (ATMP) such as CAR T, lentiviral vectors and gene therapy products.· Demonstrated expertise in CQA assessment and developing control...SuggestedFull timeLocal area
$270k - $290k
...growing biotech or biopharmaceutical company.Experience with cell therapy, biologics, or other advanced therapy medicinal products (ATMPs) strongly preferred.Strong knowledge of batch disposition, deviation/CAPA management, change control, and annual product review processes...SuggestedFlexible hours- ...communication skills, including executive presentation and board-level reportingPreferredCell and gene therapy or advanced therapy (ATMP) experienceExperience in a clinical-stage company transitioning to commercial (first BLA/MAA)Enterprise risk management experience (...SuggestedFull timeContract workRemote work
$75k - $100k
...environment with exposure to production scheduling, supply chain planning, or GMP manufacturing; Experience working in CDMO biotech or ATMP (Advanced Therapy Medicinal Products). Particularly cell and gene therapy, is highly desirable. Proficiency with ERP systems (SAP...SuggestedContract workShift work$146.8k - $231k
...customers to develop and produce lifesaving therapeutics in Small Molecule, Biologics, Vaccines and Advanced Therapies & Medicine Products (ATMP).About the roleThe Senior Manager, Application and Innovation Enablement is responsible for leading the strategic development,...SuggestedFull timeWork experience placementWork at office- ...IQ/OQ and PQ activities for new installations This Position Will Include Activities For Radiopharma, Pharma And Cell & Gene Therapy (ATMP) Projects In North America; Including, But Are Not Limited To Radiopharma - shielded hot cells and automation, synthesis and...Work experience placementWork at officeRemote work
- ...Medpace also offers certificate programs in medical device, rare disease, infectious disease, advanced therapeutic medicinal products (ATMP), and COVID-19. We are seeking applicants with experience in the following indications:Solid TumorBreast, Ovarian, Prostate,...Contract workWork at officeRemote workWork from home
- ...the implementation, execution, and maturation of Quality Systems for cell therapy products to be compliant with specific country CGMP/ATMP requirements. Supplier Oversight: Oversee local suppliers involved in the distribution of Kite products. Apheresis and Infusion...Work at officeLocal area
- HDR is providing PM/CM services for the Los Angeles World Airports ATMP Landside Improvements Project, a critical roadway, streets, and thoroughfares improvement around Los Angeles International Airport (LAX). The project spans design, preconstruction, and construction...Contract workTemporary workFor contractorsWork at officeFlexible hoursNight shiftWeekend work
$210k - $260k
...negotiate with regulatory authorities. Desired Skills: Deep understanding of FDA regulations for Advanced Therapy Medicinal Products (ATMPs). Strong strategic thinking and ability to balance short-term needs with long-term vision. Exceptional communication and...Temporary workLocal area$200k - $235k
...experience with IND/CTA and BLA submissions and global regulatory interactions required. Deep knowledge of CMC development for biologics/ATMPs, Module 3 structure and expectations, and comparability and change management strategies. Familiarity with global regulatory...Full time- ...Laboratories is seeking a Director of Biologics, Cell & Gene Therapy to lead technical operations, business growth, and service delivery for ATMP/CGT programs in a client-facing capacity. You will direct analytical development, process transfer, and regulatory readiness across...
$191k - $202k
...Expertise: Strong preference for experience in Cell/Gene Therapy, Biologics, Tissue Engineering, or Advanced Therapy Medicinal Products (ATMPs). Regulatory Compliance & Inspections: Expert understanding and practical application of global regulatory guidelines (FDA, EMA,...Local area- ...SAT, IQ/OQ and PQ activities for newinstallations Thispositionwillinclude activities forRadiopharma, Pharma and Cell & Gene Therapy (ATMP) projects in North America;including,butarenotlimited to: Radiopharma-shieldedhotcellsandautomation,...Work experience placement
$22.97 - $31.07 per hour
...Electronics Technician Maintenance (ETM) I in support of the Warfighter Training Readiness Solution (W-TRS) Contract, formally known as ATMP. DRTS program is the enabler of range modernization for tactical vehicle training. DRTS provides the infrastructure and...Hourly payContract workTemporary workImmediate startRemote workWorldwideFlexible hoursDay shift$126k - $244.2k
...Development team is seeking an Advisor to support analytical development for genetic medicines and advanced therapy medicinal products (ATMPs). This role is primarily laboratory-based, with responsibility for developing and qualifying analytical methods that characterize...Flexible hours- ..., FDA guidance, and other external regulatory authority requirements related to the manufacturing of cell-based products, including ATMPs and Annex 1. Experience conducting training for junior operators or new manufacturing staff. Experience with Aseptic Processing Simulation...Work at officeLocal area
$170k - $218k
...including leadership responsibilities. Experience supporting biologics, cell therapy, and/or advanced therapy medicinal products (ATMPs) preferred. Strong working knowledge of GMP regulations with demonstrated knowledge of FDA, EMA, ICH, and applicable global GMP, GCP...Contract work$85k - $125k
...international agencies Provide regulatory support during internal project development involving advanced therapy medicinal products (ATMPs), including cell and gene therapy (CGT) products Key skills and experience required: Strong technical background and familiarity...For subcontractor$199.22k - $284.6k
...experience in development, manufacture, or commercialization of cell therapy, gene modified cell therapy, regenerative medicine products, ATMPs, CAR-T, TCR-T, stem cell therapies, or related advanced therapeutic modalities.Strong understanding of allogeneic manufacturing...Work at officeWork from homeWorldwide