Director, CMC Statistics & Data Analytics
Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated seeks a CMC Statistics Director (Scientific Fellow) to lead statistical science across the product lifecycle, from development to regulatory submissions. You will establish the CMC Statistics Center of Excellence, drive DOE, CPV, and process analytics, and partner with Development, MSAT, Quality, Regulatory, and Data & Digital teams to enable data-driven decisions. The role emphasizes scientific excellence, collaboration, and continuous improvement, with #J-18808-Ljbffr Vertex Pharmaceuticals Incorporated
$193.1k - $289.7k
Job Description GENERAL SUMMARY The CMC Statistics Director (Scientific Fellow) provides strategic and... ..., including process development, analytical development, manufacturing, process validation... ...CMC Statistics capability, enabling data-driven decision-making to enhance...SuggestedSummer workRemote workFlexible hours2 days per week$154.4k - $242.55k
...empower you to shine? Join us as Associate Director, Statistics in our Cambridge, MA office. At... ...and other stakeholders. The R&D Data and Quantitative Sciences organization... ...SQS) department integrates data science, analytics, and quantitative methods to enhance efficiency...SuggestedMinimum wageFull timeTemporary workWork at officeLocal areaRemote work$195k - $330k
...goals are shared, our decisions data-driven and our camaraderie... ...make an impact:Drive end-to-end CMC program management for mid to... ...drug substance, drug product, analytical, quality, regulatory, and supply... ...(M.S.) of CMC experience; Sr. Director level requires commensurate...Suggested$202.13k - $336.88k
...out more:Our approach to R&DPosition Summary:As the Senior Director, Early Phase CMC Medicine Research Leader you will ensure the successful... ...Optimization. Define the integrated drug substance, drug product, analytical, manufacturing, supply chain, quality and CMC regulatory...SuggestedFull timeLocal area$166.4k - $249.6k
...DescriptionGeneral Summary:The Chemistry Manufacturing Controls (CMC) Associate Director leads and executes global regulatory CMC strategies across... ...review, and consistency checksDrives structured content and data traceability approachesSupports AI/digital capability...SuggestedFull timeSummer workRemote workFlexible hours2 days per week$156.6k - $234.8k
...Manufacturing Process & Technical Quality Associate Director provides end-to-end l quality oversight... ....Serve as the Quality representative on CMC Governance forums to ensure compliant... ...process lifecycle management platforms, data analytics, automation technologies, and emerging...Full timeContract workSummer workRemote workFlexible hours2 days per week$170.9k - $231.3k
Overview The Associate Director, Regulatory Affairs CMC Development is responsible for developing and implementating global CMC regulatory strategies for development-stage programs. This role will play a critical part in shaping regulatory strategies for emerging therapeutic...Full timeTemporary workWork at officeLocal areaFlexible hours$154.4k - $242.55k
...GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute... ...intelligence beyond regulations. Strong analytical or process understanding that enables the... ...defines CMC content (data and documentation) requirements for regulatory...Minimum wageTemporary workLocal areaRemote workWorldwide- Job DescriptionGeneral Summary:The Associate Director, CMC Quality Compliance and Inspection Readiness, is responsible for inspection readiness and compliance of external sites including evaluating, improving, and monitoring commercial level quality compliance and quality...Full timeSummer workRemote workFlexible hours2 days per week
$173k - $285.33k
...outcomes. What You'll Do As a Director/Senior Director, CMC Drug Substance Development, you will... ...development, formulation development, analytical development, Quality Assurance, and... ...by Design : Experience applying statistical design and analysis of experiments;...$136.51k - $204.77k
...Job Title: Associate Director, CMC Lead Introduction to role: Are you ready to lead early-stage CMC... ...contribute to authoring high-quality documentation and data packages for IND/IMPD submissions. API/Drug Product/Analytical Integration: Coordinate API, drug product, and...Hourly payTemporary work- Vertex is a global biotechnology company seeking an Associate Director in CMC to lead global regulatory strategies for biologics, authoring... ...role emphasizes AI-enabled regulatory document preparation and data integrity to improve efficiency and compliance. You will guide...
$170k - $195k
Description Of Role Centessa’s CMC group is currently seeking an (Associate) Director of Drug Product within the CMC group to support our early stage programs... ...clinical and commercial scale. Proficiency with analytical and solid-state characterization techniques, including...Full timeContract work- ...execute the IT solutions roadmap for CMC digital transformation. Oversee implementation... ...of Drug Substance/Drug Product/analytical methods and data. Enable creation, transformation, and... .../batch execution data, and derived statistical/trending outputs. Standardize/...Flexible hours
$167k - $300.7k
...seeking a dynamic and experienced Director, CMC Stability to lead an end-to-... ..., and ensure stability data are generated, interpreted,... ...talent, and influence across Analytical Development, Quality,... ...oversee stability data trending, statistical analysis, expiry assessments...Permanent employmentFull timeWork at officeWork from home$193.5k - $338.8k
...Boston, Massachusetts.Purpose:The Project Statistician at the Director level provides statistical leadership in multiple dimensions including:Provides... ...or be accountable for selecting statistical methods for data analysis, authoring the corresponding sections of the protocol...Local areaFlexible hours$195.42k - $370.53k
...then consider a career in Advisory.KPMG is currently seeking a Director, Private Equity IT M&A -Due Diligence and Value Creation to... ...take-out, operating modelredesign, and the implementation of data analytics and automation to acceleratethe investment thesis and drive EBITDA...H1bLocal area- ...Associate Director, Regulatory Affairs CMC Founded over a decade ago, CRISPR Therapeutics is a leading biopharmaceutical company focused on developing transformative gene-based medicines for serious human diseases. The Company has evolved from a pioneering research...Contract workRemote work
- ...The Associate Director of Regulatory Affairs CMC will be responsible for developing, implementing and advising on global Regulatory CMC strategies... ...Japan. Ensure accuracy of CMC requirements for validated analytical testing and manufacturing of Phase 3 material, including...
- Centessa Pharmaceuticals in the US is seeking an (Associate) Director of Drug Product within the CMC group to support early stage programs. Lead external CROs/CDMOs and oversee nonclinical formulation development for NCEs, with hands-on manufacturing experience across oral...
- Vertex Pharmaceuticals Incorporated is seeking an Associate Director to lead CMC Quality Compliance and Inspection Readiness. You will drive inspection readiness for external operations, collaborate across functions, and guide risk assessments and CAPA closures to sustain...Remote work
- Director/Associate Director, Cell Therapy CMC & Manufacturing We are seeking a highly experienced and visionary leader of CMC & Manufacturing to lead our cell therapy development programs. The successful candidate will help lead CMC strategy, manage process development...
- Vertex Pharmaceuticals Inc. seeks an Associate Director, CMC Quality Compliance and Inspection Readiness in Boston. You will own inspection readiness for external sites, drive continuous improvement of quality programs, and lead cross-functional teams to address risks and...
- ...Alnylam Switzerland GmbH in Cambridge, MA is seeking an Associate Director, Regulatory Affairs CMC to lead the development and execution of global regulatory strategies for innovative therapeutics, particularly in CMC Development. This role combines scientific expertise...
$200.7k - $271.5k
Director, Statistical Programming Technical Solutions Summary of Key ResponsibilitiesDesigns and leads Quantitative Sciences data and analytics systems strategy and/or technical development initiatives including systems and technology integration, data sharing, analysis...Full timeTemporary workLocal areaFlexible hours- Associate Director, CMC Product Development - Small Molecule About Beeline Medicines: Beeline... ...stability programs in collaboration with Analytical Development, including protocol design, shelf‑life determination, and stability data interpretation in support of regulatory...Contract workLocal areaImmediate start2 days per week
$235k - $285k
...and making our One Team culture thrive. Join us as a Senior Director, CMC Technical Lead , and you’ll be part of a culture that welcomes... ...technical SMEs to integrate nonclinical, formulation, process and analytical development, manufacturing and regulatory plans.Partner with...Temporary workLocal area$142.5k - $256.5k
The RoleThe Associate Director, Global Regulatory, CMC will be responsible for coordinating regulatory CMC... ...Manufacturing, Quality and Process/Analytical Development groups regarding their applicability... ...may involve access to technology or data that is subject to U.S. export...Permanent employmentFull timeWork at officeWork from home- Description As a Technical Director for the Commercial Auto line of business, the successful candidate will be a positive influence... ...to profitable business.Analyze and Optimize: Use data analytics and industry insights to identify trends, develop actionable...Work at officeLocal areaWork from home
$141k - $225k
.... You will partner closely with Engineering, Product, Science, Analytics, and Supply Chain business teams to deliver scalable solutions... ...requirements and execution plansCoordinate across engineering, data science, product, and operations teams to deliver scalable and...Local areaFlexible hours
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