CMC QA Lead - Gene Therapy & Regulatory Readiness
The Steely Group
The Steely Group seeks a CMC QA Consultant to provide quality oversight across gene therapy programs, collaborating with PD, MSAT, CMC, Manufacturing and Regulatory Affairs to ensure cGMP compliance from clinical to commercial stages. Reporting to the Director of CMC QA, you will review batch records, deviations, tech transfer plans, and regulatory submissions, while leading investigations and supporting CMOs to sustain product quality and continuous process improvements. #J-18808-Ljbffr The Steely Group
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$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... ...regulatory strategies with manufacturing readiness and supply continuity.This is a hybrid role...RegulatoryFull timeTemporary workLocal area$195k - $330k
...focused on building an industry-leading pipeline of oral small... ...convenient, highly effective therapies for patients with these conditions... ...and execution of global regulatory CMC strategies for degrader... ...regulatory compliance and submission readiness.Scale and lead the...Regulatory$250k - $273k
...commercializing novel therapies for diseases with unmet... ...medicines, anchored by its lead product, ARCALYST, the... ...alignment with regulatory requirements and industry... ...complaints, and inspection readiness, and partners cross-functionally... ....Collaborate with CMC, Regulatory Affairs,...RegulatoryWork at office$290k - $323k
...’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company... ...Lead and/or oversee global regulatory CMC submissions (e.g., INDs, CTAs,... ...ensure global compliance and readiness for clinical and commercial supply...RegulatoryContract workTemporary workFor contractorsFlexible hours- ...Director/Senior Director, Regulatory CMC Immuneering Corporation (Nasdaq... ...company developing oncology therapies using its proprietary Deep... ...Inhibition platform. Our lead asset, atebimetinib (IMM-1-1... ...ensure regulatory compliance and readiness; partner effectively with...RegulatoryRemote workFlexible hours
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- ...quality assurance oversight across CMC development, Quality Control,... ...compliance with global regulatory requirements and internal quality... ..., and regulatory inspection readiness while supporting the... ...Rewards, inclusive of market-leading benefits to meet our employees...RegulatoryFull timeContract workImmediate start
$195k - $330k
...building an industry-leading pipeline of oral small... ...convenient, highly effective therapies for patients with... ...:Drive end-to-end CMC program management for... ...analytical, quality, regulatory, and supply chain workstreams... ..., and commercial readiness activities for oral solid...Regulatory$145k - $150k
...developing and commercializing novel therapies for diseases with unmet need,... ...medicines, anchored by its lead product, ARCALYST, the first... ...leads to manage complex CMC activities for one or more products... ...combination product, supply chain, and regulatory activities. The CMC project...RegulatoryContract workWork at officeFlexible hours- Role: CMC Program Operations Manager leading digital transformation and operational excellence in biopharma, specifically within cell & gene therapy development. Responsibilities Develop and maintain integrated... ...functional coordination with Regulatory, Manufacturing, Quality, and...Regulatory
$313k - $348k
...:Prime Medicine is a leading biotechnology company... ...the next generation of gene editing therapies to patients. The... ...clinical development and regulatory path, and each... ...leaders across Research, CMC, Clinical Development... ...functional regulatory readiness, including preparation...RegulatoryFull timeContract workTemporary work- ...Biosciences, Inc. (MBX) Regulatory Affairs Fellow position... ..., and Controls (CMC), Regulatory Operations... ...and late-stage programs. Lead targeted research initiatives... ...for submission-readiness, to ensure that all submissions... ...precision peptide therapies based on its proprietary...RegulatoryWork at officeLocal area
$118k - $166k
...that's pursuing curative gene therapies to give patients and... ...with cGMP regulations, regulatory commitments, and Genetix... ...expected to serve as a CMO Lead point-of-contact and... ...Provide on-call QA support for manufacturing... ...detail with an inspection-ready mindset Key Success...RegulatoryFull timeContract workWork at office3 days per week$185.6k - $232k
...3, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.... ...Research, ensuring end-to-end regulatory compliance, scientific... ...leadership on GCP and GLP QA support and guidance to key... ....Support inspection readiness activities for sponsors, monitors...RegulatoryFull time$181k - $213k
...TANGO (Targeted Augmentation of Nuclear Gene Output) approach, Stoke is developing antisense... ..., visit Position Purpose: The Regulatory CMC Senior Manager is responsible for contributing... ...global CMC regulatory strategies, leading lifecycle management initiatives, and providing...RegulatoryTemporary workRemote work$186k - $200k
...developing and commercializing novel therapies for diseases with unmet need,... ...medicines, anchored by its lead product, ARCALYST, the first... ...with company policies and regulatory requirements. The Associate... ...ReadinessParticipate in inspection readiness activities and provide back-...RegulatoryWork at office- ...Vice President, Regulatory Affairs At Editas... ...potential of CRISPR gene editing to transform... ...Regulatory Affairs will lead and build the... ...vivo gene editing therapies, serving as the company... ..., durability, and CMC comparability.... ...feasible, and regulatory-ready. Personally plan...Regulatory
- Editas Medicine seeks a Vice President, Regulatory Affairs to lead our global regulatory function for in vivo gene editing therapies from discovery through regulatory submissions. Based in Cambridge, MA, this hands-on leader will shape strategy and build processes in a...Regulatory
$177k - $278.08k
...innovation and delivers transformative therapies to patients. By focusing R&D efforts on... ...therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant... ...support teams. How you will contribute: Lead site-specific post-approval change management...RegulatoryMinimum wageFull timeLocal areaRemote workWorldwide$176.9k - $221.22k
...commercialization of transformative therapies for patients with... .... Obexelimab, Zenas’ lead product candidate, is a... ...Development, Quality, Regulatory, and Manufacturing to ensure analytical readiness and compliance.Serve as... ...ICH guidelines.Support CMC strategy, inspections,...Regulatory$188k - $204k
...commercializing novel therapies for diseases with unmet... ...medicines, anchored by its lead product, ARCALYST, the... ...teams to be inspection ready, in support of a... ...procedures as well as regulatory guidelinesSupport Oversight... ...sitesProvide Clinical QA oversight of GCP protocols...RegulatoryContract workWork at officeImmediate startRemote workWorldwide- ...Director of Quality Control to lead strategy, leadership, and... ...testing, and release of cell-therapy products. The role collaborates... ...Assurance, Manufacturing, and regulatory affairs, guiding lab... ...timely testing, and inspection readiness. #J-18808-Ljbffr Vericel CorporationRegulatory
$170k - $218k
...to discover and develop therapies that can unleash the... ...Assurance will oversee GMP QA operations for internal... ...and contribute to regulatory submissions. This role... ...to GCPs and Inspection Readiness in collaboration with Agenus... ...timely response. Lead the development, implementation...RegulatoryContract workFlexible hours- ...Stoke Therapeutics seeks a Vice President to lead regulatory strategy and CMC functions across its antisense oligonucleotide pipeline. This executive... ...interactions Oversee CMC strategy, manufacturing readiness, and technical operations alignment with regulations...Regulatory
- ...Vice President, Regulatory Strategy & CMC About the Company Expanding biotechnology (BioTech)... ...successful candidate will be responsible for leading the development and execution of... ..., pharmaceutical, or cell and gene therapy industries, and a minimum of 6 years...Regulatory
$200k - $260k
...to build a world leading oncology company bringing... ...the next wave of therapies for cancer... ...PPQ, and commercial readiness, including BLA support... ...demand. Lead QA input into CDMO... ...Partner closely with CMC, Technical... ...Supply Chain, and Regulatory teams to embed quality...RegulatoryContract workTemporary workFlexible hours- Stoke Therapeutics is seeking a Regulatory CMC Senior Manager to contribute to global regulatory strategies, lifecycle management, and cross... ...to the Director of Regulatory CMC. The role focuses on leading CMC regulatory strategies for development and potential commercialization...RegulatoryRemote job
$264k - $271k
...commercializing novel therapies for diseases with... ..., anchored by its lead product, ARCALYST,... ...Clinical and CSV QA to ensure process... ...labels to support regulatory submissions and... ...supplyInspection readiness and ensuring all documents... ...closely with CMC/Tech Ops, Quality,...RegulatoryWork at officeFlexible hours$160k - $170k
...developing and commercializing novel therapies for diseases with unmet need... ...medicines, anchored by its lead product, ARCALYST, the first... ...Operations, Quality, Regulatory, CMC/Manufacturing, and external... ...assumptions, and operational readiness with study teamsLead...RegulatoryContract workWork at officeFlexible hours
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