Senior Analytical CMC Specialist: Method Validation & Transfer
RXinsider LTD.
Moderna in Norwood, MA is seeking an analytical CMC professional to provide executional support for method-related activities across late-phase development and commercial programs. You will contribute to method validation, transfer, and lifecycle management in support of regulatory submissions and commercial readiness. The role emphasizes hands-on execution, coordination, and documentation across cross-functional teams and external partners in a regulated biopharma environment. #J-18808-Ljbffr RXinsider LTD.
$89.9k - $143.8k
...based at its Norwood, MA site. This role will provide analytical CMC executional support for method-related activities across late-phase development... ...individual will contribute to analytical method validation, transfer, and lifecycle management activities in support of...SuggestedPermanent employmentFull timeWork at officeWork from home$135k - $215k
...together.Opportunity OverviewThe Analytical Chemistry Manager is... ...the development, optimization, validation, and transfer of analytical procedures for... ...Author and review regulatory CMC submissions including analytical procedures, method validations, reference standards...SeniorContract workWork at officeFlexible hours$210k - $300k
...together.Opportunity OverviewAs the Senior Director, Analytical Development and Quality Control,... ...product lifecycle, including method development, validation, transfer, and lifecycle management from... ...external laboratories.Regulatory & CMC ContributionProvide strategic...SeniorContract workWork at office- Orna Therapeutics, Inc. seeks a Senior Principal Scientist to drive analytical characterization of circular RNA and lipid nanoparticle therapeutics... ...collaborate with Platform Science, Discovery, and CMC to advance method development and product characterization in a fast...Senior
- We are seeking a Senior Associate to join our Transfer Pricing team, offering the opportunity to influence client... ...requests, responses, and analytics Support project managers in conducting... ...operational, R&D, and commercial teams to validate facts and decision‑making Build and...SeniorTemporary workWork at officeFlexible hours
$138.4k - $207.6k
...Scientist, Microbiology to join the Analytical Science & Technology (AS&T)... ...for microbiological methods and microbial control strategies... ...method qualification, validation, transfer, implementation, monitoring,... ...Collaborate with Regulatory CMC, Quality, Manufacturing, Supply...Full timeContract workSummer workRemote workFlexible hours2 days per week$195k - $330k
...make an impact:Drive end-to-end CMC program management for mid to late... ...drug substance, drug product, analytical, quality, regulatory, and supply... ...execution of Phase 3, registration and validation campaigns, commercial-scale technology transfer, and commercial readiness...Senior$195k - $330k
...and execution of global regulatory CMC strategies for degrader programs across... ...regulatory CMC guidance to senior leadership regarding health authority... ...authorities).Experience with small molecule analytical method development/validation, specification setting, and post-...Senior$235k - $285k
...culture thrive. Join us as a Senior Director, CMC Technical Lead , and you’ll... ...nonclinical, formulation, process and analytical development, manufacturing... ..., or in any form and method will be deemed the sole... ...for this requisition and a valid agreement with Halozyme Hypercon...SeniorTemporary workLocal area$70 per hour
[Contract] Sr. Specialist, Quality Assurance for Quality Control... ..., qualification, and validation (CQV) tasks, you will be... ...Familiarity: Deep understanding of analytical or microbiological QC testing instruments, method validation, and method transfer. Digital Quality...SeniorHourly payPermanent employmentContract workTemporary workWork experience placementRelocationShift work$70k - $115k
...The (Sr) Associate Scientist, Analytical Development will support analytical... ...execute analytical testing, support method development, qualification, and transfer activities, maintain high-quality... ...development, qualification, validation, and technology transfer principles...SeniorContract workTemporary work$121.6k - $194.5k
The RoleThe Senior Data Product Manager will own the prioritization, definition... ...and AI use cases across Moderna's CMC organization. This role operates... ...operationally viable, not just analytically correct· Define data quality, validation, and traceability requirements to...SeniorPermanent employmentFull timeWork at officeWork from home$121k - $173k
...FM is seeking a Senior Research Scientist to... ...smoke generation, heat transfer, and related areas.... ...scientists to develop and validate sub-models related to... .... Communicate test methods, results, and engineering... ...experience in experimental and analytical methods in thermal...SeniorFull timeFlexible hours$173k - $285.33k
...What You'll Do As a Director/Senior Director, CMC Drug Substance Development, you will... ...GMP production, GMP production, tech transfer, validation, and drug substance manufacturing activities... ..., formulation development, analytical development, Quality Assurance, and...Senior$75 - $110 per hour
...s needs a Cell Therapy Analytics Specialist. This is a contract position... ...supporting analytical method qualification, validation, and lifecycle... ...operates under the guidance of senior analytical and quality... ...validation programs, and assay transfers. Help identify...Hourly payContract workFor contractorsLocal area$90k - $110k
...additional remote days to be used as needed.The Portfolio Analytics team is seeking a Senior Associate to help lead and evolve our third-party vendor... ...risks and controlsSupport data quality efforts through validation, reconciliation, and issue resolution processesPerform...SeniorFull timeWork at officeLocal areaRemote work1 day per week- ...are seeking a highly motivated Senior Scientist with expertise in... ...candidate will perform hands-on analytical research focused on antibody-... ..., and apply analytical methods that support discovery and early... ...and SIM-MS.Develop, optimize, validate, and troubleshoot analytical...Senior
- Integra LifeSciences is seeking a Supervisor, QC Analytical Laboratory to lead the analytical laboratory operations and ensure compliant... ...and finished products. The role focuses on data integrity, method validation, and regulatory readiness. You will oversee lab activities,...Senior
$145.9k - $234.2k
...enterprise data architecture that makes CMC data usable, governable, and AI-ready at... ...and semantic structures that support both analytics and AI use cases across CMC domains·... ...agentic AI workflows · Background in GxP validation readiness for data platforms and how architectural...Permanent employmentFull timeWork at officeWork from home$203k - $338.3k
...Regulatory & Financial Risk - Senior Manager - Model Validation Our Deloitte Regulatory,... ...using appropriate methods (for example: benchmarking... ...Connect and collaborate with specialists across Deloitte to... ...processes, controls, and data & analytic infrastructures....Senior$52k - $94.12k
...you are up for. What you will be responsible for As an Senior Associate in the Transfer Agency Alternatives Team, you will: Serve as operational... ...quality - detail oriented Strong organizational and analytical skills Time management skills - ability to prioritize...SeniorTemporary workFlexible hours$226.1k - $339.1k
Job DescriptionGeneral Summary:The Senior Director, Analytical Development is a senior leadership role within... ...Development, Regulatory, Quality, CMC, and external partners to generate... ...strategies using manual and automated methods to support process development, process...SeniorFull timeSummer workFlexible hours$142.4k - $224.1k
...Process Modeling & Analytics team within the... ...impact across the CMC space. In this Associate... ...decisions. As a senior member of the... ...Build, calibrate, and validate mechanistic... ...isotherm and mass-transfer parameter estimation... ...modeling, numerical methods, and simulation-based...Full timeFor contractorsLocal areaVisa sponsorshipFlexible hours$89.59k - $197.46k
...you to shape your own future.KPMG is currently seeking a Senior Associate, Credit Specialist to join our Audit practice.Responsibilities:Execute the... ..., along with strong communication, interpersonal, analytical skills, and research abilitiesAdhere to the firm's values...SeniorLocal area$55k - $157.3k
...company’s success. As a Quantitative Analytics and Modeling Analyst Senior within PNC's Model Risk Management... ...are seeking an experienced model validator to be part of our Model Risk Management... ..., the job ID, and your preferred method of contact in the body of the email...SeniorFull timeTemporary workPart timeWork experience placementWork at office- Senior Scientist, Analytical Development (Project Management) Job Description Company Overview Founded... ...lead cell-based analytical technology transfers from Analytical Development to collaborators... .... Experience with leading analytical method transfer and supporting process...SeniorContract work
$160k - $185k
...development happening around the world.Senior Quantitative Analyst,... ...Quantitative and Risk Analytics group is hiring a Senior Quantitative... ...communication.Maintain, validate, and enhance portfolio and risk... ...to provide visa sponsorship/transfer for this position, now or in...SeniorFull timeLocal area- ...Moderna is seeking a CMC Product Lead to oversee and execute CMC strategies across multiple assets from first in human to pivotal studies. You will align program strategy with TPP/QTPP, translate plans into actionable, prioritized CMC tasks, and interface with Resilience...Senior
$88k - $145k
...Relocation support is offered for eligible candidates.The Senior Production Underwriting Specialist supports Commercial Underwriting leaders in achieving... ...problem solving, critical thinking, quantitative and analytical skills.Strong excel skills required, ability to pull...SeniorFull timeWork at officeLocal areaRelocationRelocation packageFlexible hours$140.8k - $211.2k
...regulatory submissionsJustification of clinically relevant dissolution method parameters and specificationsUnderstanding of key analytical deliverables for late-stage programs including method development, validation, specification setting, stability, release testing and...Full timeSummer workFlexible hours
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