Lead Quantitative Scientist, CMC Analytics & Regulatory
Moderna
Moderna seeks an accomplished Quantitative Scientist to join the CMC QS team as Principal Scientist in Norwood, MA. You will deliver advanced quantitative solutions across the product lifecycle, influencing regulatory filings and lifecycle management with data-driven tools. You will collaborate across Process Development, Analytical Development, Quality, Manufacturing, and Digital to shape strategy, deploy scalable analytics, and mentor the team while advancing Moderna's mission and values. #J-18808-Ljbffr Moderna
- Moderna is seeking an accomplished Quantitative Scientist to join the CMC QS team as Director in Norwood, MA. You will lead a small, high-impact team of statisticians and data... ...across the product lifecycle, from regulatory filings and lifecycle management to automated...Regulatory
$130.8k - $209.4k
...strategic, hands-on Senior Scientist to join the CMC Quantitative Sciences (QS) team in... ...Science and Technology, Analytical Development, and Technical... ...problems. You will also support regulatory submissions and help... ...platform.Here’s What You’ll Do:Lead statistical support for...RegulatoryPermanent employmentFull timeWork from home$109.2k - $174.6k
...Moderna is seeking a hands-on Scientist to join the CMC Quantitative Sciences (QS) team in... ...and platform, and analytical method lifecycles.In this... ...manufacturing, analytical, quality, regulatory, and digital teams to... .... You will independently lead complex analyses and...RegulatoryPermanent employmentFull timeWork from home$142.5k - $256.5k
...accomplished and visionary Quantitative Scientist to join our Chemistry... ...Sciences (CMC QS) team as a Principal... ...product lifecycle, from regulatory filings and lifecycle... ...Process Development, Analytical Development, Quality,... ...robust data analysis.Lead the design and application...RegulatoryPermanent employmentFull timeSeasonal workWork from home$142.5k - $256.5k
...accomplished and visionary Quantitative Scientist to join our Chemistry... ...Sciences (CMC QS) team as a Principal... ...product lifecycle, from regulatory filings and lifecycle... ...Process Development, Analytical Development, Quality,... ...robust data analysis. Lead the design and...RegulatoryPermanent employmentSeasonal work- Moderna seeks a Director-level Quantitative Scientist for the CMC QS team in Norwood, MA. You will lead a small team delivering... ...partnering with Process Development, Analytical Development, Quality, Manufacturing and Digital to guide regulatory submissions and data-driven...Regulatory
- Moderna is seeking a Principal Scientist in Norwood, MA to lead quantitative science across CMC. You will deliver advanced statistical solutions, guide regulatory submissions, and deploy data‑driven... ...with Process Development, Analytical Development, Quality, and Manufacturing...Regulatory
$109.2k - $174.6k
...role, you will join the Analytical Sciences team within... ...as a scientific lead for the transfer and... ...grasp of GMP and global regulatory expectations. You will... ...(AST), QC, Quality, Quantitative Sciences, and Regulatory... ...method-development scientists before formal handoff...RegulatoryPermanent employmentFull timeWork from home- Moderna in Norwood, MA seeks an analytical CMC professional to provide executional support for method validation, transfer, and lifecycle... ...cross-functional teams, prepare documentation, and help ensure regulatory readiness while operating in a GMP-regulated biopharma...Regulatory
$142.5k - $256.5k
The RoleThe Global Regulatory CMC Lead will be responsible for coordinating regulatory CMC activities for one or more products, depending... ...and directives - advises Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact...RegulatoryPermanent employmentFull timeWork at officeWork from home$128k - $146k
...Description Position Summary The Scientist II, Analytical Development will be a key... ...disease. The candidate will lead method development, impurity... ...within AD/QC and with CMC teams to develop and... ...summarize analytical activities for regulatory filing. Perform/guide...RegulatoryFull time$138.4k - $207.6k
...Pharmaceuticals is seeking a Principal Scientist, Microbiology to join the Analytical Science & Technology (AS&... ...and Responsibilities:Lead microbiology method... ...initiatives.Support regulatory submissions, health authority... ...with Regulatory CMC, Quality, Manufacturing,...RegulatoryFull timeContract workSummer workRemote workFlexible hours2 days per week$109.2k - $174.6k
...technical leadership and execution support for analytical method lifecycle management across... ...Quality Control, Quality Assurance, Regulatory Affairs, Manufacturing Sciences, and Contract... ...strategies. Here's What You’ll Do Lead and support chemistry-focused analytical...RegulatoryPermanent employmentFull timeContract workWork from home$138.4k - $207.6k
...DescriptionGeneral Summary:The Analytical Science and Technology (AS&T) Principal Scientist, Separation Method... ...and Responsibilities:Lead analytical method... ...program commitments.Support regulatory submissions and responses... ...and commercial-stage CMC. Familiar with analytical...RegulatoryFull timeContract workWork experience placementSummer workRemote workWorldwideFlexible hours2 days per week- Moderna seeks an Associate Director of Global Regulatory Affairs, CMC, to lead LATAM regulatory activities and ensure high-quality CMC submissions. This role oversees agency communications, and regulatory applications, coordinating cross-functional teams in a fast-paced...Regulatory
$100k - $120k
...an experienced and hands-on Analytical Chemist to join the R&D Research... ...technical reports. • Lead QA/QC activities related to... ...method development, validation, quantitative analysis, and instrument... ..., and knowledge of relevant regulatory guidelines (FDA, ICH, ISO, REACH...RegulatoryFull timeContract work$150.5k - $245.5k
...together:The successful candidate will lead the strategy and execution of complex early... ...biomarkers.Lead the interaction with regulatory agencies and site ethic committees for approval... ...in the application of imaging as a quantitative endpoint in clinical and preclinical...RegulatoryFull time- Moderna Therapeutics is seeking an Associate Director of Global Regulatory Affairs, CMC, to oversee CMC and Quality agency correspondence and regulatory applications for global products. You will lead regulatory activities, ensure high-quality CMC sections, and manage...RegulatoryWork at office
$105k - $114k
Principal Associate Scientist Of Analytical Development & Operations Strand Therapeutics... .... Primary Responsibilities: Leads development of analytical... ..., MSAT, Quality, and other CMC functions to support process... ...process development, and/or regulatory aspects of mRNA-(lipid)...RegulatoryFull timeContract workWork experience placement$145.9k - $234.2k
...manufacturing data historian and operational analytics systems to design, implement, support,... ...structured root-cause analysis.· Lead or support system lifecycle activities including... ...law. Due to the nature of the work and regulatory requirements, only individuals who...RegulatoryPermanent employmentFull timeWork from home- ...in Watertown, MA, seeks an experienced scientist to lead bioanalytical LC-MS/MS method... ...programs. Responsibilities include designing quantitative assays for protein/peptide biomarkers... ...mentoring junior scientists while ensuring regulatory compliance and high data quality. #J-...Regulatory
- ...Regeneron seeks an Imaging Science Lead to direct oncology imaging strategy and biomarker... ...cross-functional teams, and ensuring regulatory compliance for PET, CT, and novel... ...Leadership experience applying imaging as quantitative endpoint in clinical and preclinical oncology...Regulatory
$109.2k - $174.6k
...enzyme process development and analytical development to define... ...inputs to manufacturing sciences, CMC, and Quality partners as needed... ...troubleshooting, regulatory-supporting documentation, or... ...we have aspired to build the leading mRNA technology platform, the...RegulatoryPermanent employmentFull timeWork from home$142.5k - $256.5k
...into actionable program, regulatory, and supply decisions.This... ...What You’ll Do:Define and lead phase-appropriate stability... ...stages.Partner closely with Analytical Development, Quantitative Sciences, Process... ...operating within cross-functional CMC team structures.Experience...RegulatoryPermanent employmentFull timeWork at officeWork from homeWorldwide- Integra LifeSciences is seeking a Supervisor, QC Analytical Laboratory to lead the analytical laboratory operations and ensure compliant testing... ...The role focuses on data integrity, method validation, and regulatory readiness. You will oversee lab activities, manage...Regulatory
$138.4k - $207.6k
...Vertex Pharmaceuticals seeks a Principal Scientist in Microbiology to lead analytical science and technology efforts for biologics, cell therapy, and... ...focuses on microbiology method lifecycle management, regulatory compliance, external laboratory oversight, and investigations...RegulatoryContract work$36 - $41 per hour
...Eurofins seeks a molecular biology scientist to support analytical development of oligonucleotide and mRNA-LNP products in Boston. The role involves... ..., and collaborating across teams while maintaining regulatory compliance and scientific documentation standards. Responsibilities...RegulatoryHourly pay$145 - $170 per hour
...Search Open Jobs View our latest job openings and see how Eastridge can help you find your next opportunity. Senior Regulatory CMC Lead Compensation: $145.00 - $170.00 Loading... Eastridge Workforce Solutions is committed to connecting skilled professionals with...RegulatoryHourly payFull timeTemporary workLocal areaRemote workMonday to FridayShift work- Anagram Therapeutics, Inc. in Natick, MA is seeking an Associate Director to lead regulatory CMC activities across a broad portfolio for clinical and commercial programs. You will plan submission strategies, coordinate cross-functional teams, and ensure submissions meet...Regulatory
- Integra LifeSciences in Massachusetts seeks a Supervisor, QC Analytical Laboratory to provide technical and operational leadership for... ...finished products and stability samples, with data integrity and regulatory readiness. You will supervise daily lab operations, oversee...RegulatoryContract work
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