Senior Scientist, CMC Regulatory Lead - New Modalities
Johnson & Johnson
Johnson & Johnson seeks a Senior Scientist Product Lead CMC RA - Synthetics, New Modalities for East Coast USA locations, Beerse or Warsaw. You will drive global CMC regulatory strategies, lead CMC teams, and prepare regulatory dossiers for Health Authorities, supporting development compounds and potentially marketed products. The role requires a BS (6+ years) in biological/chemical/engineering fields (MS/PhD preferred), strong regulatory writing, cross-functional collaboration, and deep #J-18808-Ljbffr Johnson & Johnson
$109k - $174.8k
...Development; Job Sub Function: Regulatory Science; Job Category: Scientific... ...States of America; Raritan, New Jersey, United States of America... ...searching for the best talent for a Senior Scientist Product Lead CMC RA - Synthetics, New Modalities to be in our East Coast USA...SeniorRegulatoryLocal areaImmediate start$190.8k - $300.3k
...understanding of regulatory expectations for immunology... ...Leaders, and scientists across NDS and/or... ...development, and CMC. Demonstrate... ..., and proactively lead internal cross‑departmental... ...therapeutic modalities. Demonstrated... ...mission to achieve new milestones in global...SeniorRegulatoryFor contractorsRelocationVisa sponsorshipFlexible hoursShift work- ...best talent for a Senior Scientist - Lentiviral Vector... ...Development, will lead development,... ...Support existing and new commercial manufacturing... ..., protocols, and regulatory-supporting... ...related viral vector modalities. Hands-on experience... ..., and Control (CMC), Coaching, Consulting...SeniorRegulatoryCasual workLocal area
- Johnson & Johnson seeks a Sr. Distinguished Scientist - PSTS Neuroscience Disease Area Lead to drive disease-specific scientific strategy across discovery... .... The role interfaces with TA leadership, regulatory, and external partners to align PSTS goals with pipeline...SeniorRegulatory
$107.6k - $161.5k
...passionate and experienced Senior Scientist/Team Leader - Bioprocess Development to lead downstream process... ..., HIC, and related modalities. Develop scalable, robust... ...to support regulatory submissions. Work directly... ...Chance Ordinance, and the New York City Fair Chance...SeniorRegulatoryHourly payMinimum wageLocal area$190.8k - $300.3k
...understanding of regulatory expectations for immunology... ...Leaders, and scientists across NDS and/or... ...development, and CMC. Demonstrate... ..., and proactively lead internal cross‑departmental... ...therapeutic modalities. Demonstrated leadership... ...to achieve new milestones in global...SeniorRegulatoryFor contractorsRelocationVisa sponsorshipFlexible hoursShift work- ...products. Today, we are building a new kind of healthcare company - one that... ...and expanding your career. The Senior Director (Sr. Principal Scientist) has primary responsibility for the... ..., placement, monitoring, analysis, regulatory reporting, and publication. Specifically...SeniorRegulatory
- ...initiation, execution, monitoring, analysis, regulatory filing, and publication). Evaluate pre-... ...). Monitor and manage ongoing and new clinical trials. Analyze and summarize clinical... ...for new compounds. Supervise Clinical Scientists; collaborate cross-functionally (...SeniorRegulatory
$173k
...Description:Sr. Distinguished Scientist - PSTS Neuroscience Disease... ...PSTS Neuroscience Disease Area Lead. Location options: Spring... ...PSTS DAL along with the PSTS Modality Lead are the primary interfaces... ...in other organizations (e.g. Regulatory affairs, Global Medical Safety...SeniorRegulatoryFull timeTemporary workLocal area$164k - $282.9k
...for a Distinguished Scientist, Nonclinical... ...includes innovative modalities. In this vital role... ...Responsibilities Lead PSTS project teams... ...interfacing with senior management. Serve... ...Accountable for global regulatory nonclinical... ...Manufacturing and Controls (CMC) functions to...RegulatoryLocal areaImmediate start- ...are searching for the best talent for a Senior Scientist, In-vivo CAR-T, to be based on-site in... ...Development, MSAT, Quality, Manufacturing, and Regulatory teams to ensure alignment on process... ...Chemistry, Manufacturing, and Control (CMC), Coaching, Consulting, Critical...SeniorRegulatoryLocal area
$282.2k
...products. Today, we are building a new kind of healthcare company - one that... ...and expanding your career. The Senior Director (Sr. Principal Scientist) has primary responsibility for the... ..., placement, monitoring, analysis, regulatory reporting, and publication. Responsibilities...SeniorRegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$231.9k - $365k
...molecules, and newer modalities, we are at the forefront... ...collaborative team of scientists (12 anatomic... ...the safety profile of new drugs from toxicology... ...including:An industry-leading suite of on-site in vitro... ...studies, and generation of regulatory strategy and communications...SeniorRegulatoryFull timeFor contractorsLocal area$117k - $184.2k
...process validation, authoring of regulatory submissions and support of... .... We are seeking a Senior Scientist to be the lead drug product scientist responsible... ...(SPR) for high-quality CMC sections for regulatory submissions... ...mission to achieve new milestones in global healthcare...SeniorRegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$117k - $184.2k
...transformative medicines. We are seeking a Senior Scientist to join our Biologics Analytical... ...readiness. Act as a new project lead by collaborating with external stakeholders... ...integrity principles, and applicable regulatory requirements. Support instrument qualification...SeniorRegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift workWeekend workAfternoon shift$117k - $184.2k
Job Description Our Scientists and Engineers support internal development... ...Development, Analytical, Regulatory, and Quality. As part of Our... ...evaluations, process characterization, new WCB qualification, and... ...across the network. Lead assignment execution against...SeniorRegulatoryContract workFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work- LexisNexis Reed Tech seeks a Senior Account Executive to drive new business in the Medical Device space, focusing on regulatory solutions that help clients meet compliance needs. You will identify prospects, conduct consultative needs assessments, and close complex deals...SeniorRegulatory
- ...best talent for a Scientist - Lentiviral Vector... ...Development, will lead development,... ...Support existing and new commercial manufacturing... ..., protocols, and regulatory-supporting... ...related viral vector modalities. Hands-on experience... ..., and Control (CMC), Coaching, Collaboration...RegulatoryCasual workLocal area
$199k - $343.85k
...cancer by discovering new pathways and modalities to finding treatments and cures. We lead where medicine is... ...the clinical project scientists and Clinical Leader in... ...Management, Statistics, Regulatory, QMMC, and GMS to... ...develops, in concert with senior clinical staff,...SeniorRegulatoryContract workWork experience placementImmediate start- Merck is seeking a senior professional to lead cell bank process transfers and technical documentation for regulatory submissions in a fast-paced vaccine/biologics environment. The role emphasizes cross-functional collaboration, DOE-driven data analysis, and adherence...SeniorRegulatory
- Merck & Co., Inc. in Rahway, NJ seeks a Senior Scientist to lead commercial DP process development for sterile products, vaccines, and biologics... ...role focuses on process validation, technology transfer, regulatory documentation, and collaboration across functions to meet...SeniorRegulatory
- Merck & Co., Inc. in Rahway, NJ is seeking a Senior Scientist to join Biologics AR&D GMP Operations team in North Wales... ...through commercialization of biologics. You will lead analytical method transfer, drive regulatory readiness, and collaborate across matrixed teams,...SeniorRegulatory
- Merck & Co., Inc. seeks a Senior Scientist to lead drug product development for sterile biologics and vaccines. The role focuses on establishing... ..., implementing DOE, authoring reports, and supporting regulatory submissions while driving cost efficiency and process robustness...SeniorRegulatory
- ...commercial cell bank programs for biologics/vaccines. You will drive cell bank process transfers, investigations, data analysis, and regulatory documentation, coordinating with internal and external partners across the network. The role emphasizes technical leadership,...SeniorRegulatory
- Johnson & Johnson in Spring House, PA is seeking a Senior Scientist, In-vivo CAR-T to advance LVV drug product processes from early to late... ...across Analytical Development, MSAT, Quality, and Regulatory teams to ensure robust, GMP-ready processes. You will design...SeniorRegulatory
- ...Rahway, NJ, USA, a BARDS division of the R&D group, seeks a senior biostatistician to lead statistical activities for drug/vaccine development. The... ...teams, and coordinating statistical analyses across regulatory and clinical units. Ideal candidates hold a PhD or equivalent...SeniorRegulatory
- ...documents including proposals, reports and regulatory agency correspondence. Design systems and... ...and how to protect the Company. Lead safety efforts for team and ensure team follows... ...on project and proposal delivery. Senior level scientific professional responsible...SeniorRegulatoryLocal area
- ...Products in the United States seeks a Senior Medical Tubing Extrusion Engineer to lead extrusion process development,... ...collaborate with Manufacturing, Quality and Regulatory teams to advance tubing products.... ...and manufacturability for new business opportunities. #J-18808-...SeniorRegulatory
$137k - $235.75k
...States of America, Raritan, New Jersey, United States of America... ...is looking for outstanding scientists and leaders whose responsibilities... ...and technical leader, leading a portfolio of RWE projects,... ...literature reviews to support regulatory agency interactions.Independently...SeniorRegulatoryFull timeLocal areaImmediate start$97.95k - $141.41k
...Senior Environmental Scientist Michael Baker International's civil engineering professionals manage and staff active projects in over 40 countries... ...and endangered species observations in accordance with regulatory requirements Assist with Phase I, II, and III...SeniorRegulatoryTemporary workWork at officeWork visaFlexible hours
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