Director, CMC Analytics & GMP Quality
Editas Medicine
Editas Medicine in the United States is seeking a highly experienced leader for the Quality team to drive gRNA, mRNA, and LNP analytical methodologies and GMP testing. This role partners with Research, Process Development, and Manufacturing to transfer and qualify testing for in‑vivo gene medicines and to shape the program CMC strategy. The candidate will lead cross‑functional teams, mentor staff, and author regulatory submissions while ensuring compliance with FDA/ICH guidelines and continuous #J-18808-Ljbffr Editas Medicine
- ...Pharmaceuticals, Inc. is seeking an Associate Director, Quality Operations to provide end-to-end quality... ...commercial programs, ensuring compliance with GMP/GDP standards. The role involves authoring and reviewing IND CMC submissions, managing quality systems, supporting...QualityRemote job
$173k - $285.33k
...outcomes. What You'll Do As a Director/Senior Director, CMC Drug Substance Development, you... ...partners for process research, non-GMP production, GMP production, tech transfer... ..., formulation development, analytical development, Quality Assurance, and CMC Regulatory Affairs...Quality$136.51k - $204.77k
...Job Title: Associate Director, CMC Lead Introduction to role: Are... ...contribute to authoring high-quality documentation and data packages... .... API/Drug Product/Analytical Integration: Coordinate API,... ...successful tech transfer to GMP facilities and effective collaboration...QualityHourly payTemporary work$160k - $180k
...beyond About the Role As the Associate Director, GMP Quality , reporting to the Head of GMP Quality... ...responsibilities for reviewing Analytical Development / Quality Control results.... ...collaborate with other functional teams such CMC, Regulatory and Supply Chain to...QualityWork experience placementWork at officeFlexible hours$210k - $290k
...scientifically bold, highly collaborative Senior Director to lead Protein Analytics & Biophysics within our Therapeutics... ..., Machine Learning, Biology, and CMC/Tech Ops, and translating an... ...robust capabilities that improve decision quality, speed, and scale.Here's how you will...QualityShift work- ...Role: As Associate Director, AS&T Projects &... ...Conjugates (ADCs) within the Analytics, Science & Technology (... ...-functional late-stage CMC team, helping drive... ...Regulatory Affairs, CMC, and Quality, ensuring compliance... ...Practice (GMP), as well as compendial...QualityHourly pay
$160k - $200k
Kiniksa is seeking an experienced Associate Director, GMP Quality Assurance Operations to be a key... ...process validation/qualification and analytical method validation and transferExecute... ...compliant closurePartner closely with CMC, Technical Operations, Analytical Sciences...QualityWork at officeRemote work- Olema Oncology is seeking an Associate Director, GMP Quality to oversee GMP activities for clinical and commercial products, including QA review... ...batch records and supplier compliance. This role partners with CMC, Regulatory and Supply Chain, and will be based in SF or...Quality
$156.6k - $234.8k
...DescriptionGeneral Summary:The Associate Director (AD) Quality Assurance (QA for QC) is an advanced... ...oversight of Quality Control and analytical development activities of Cell & Gene... ...including quality systems, compliance and GMP regulations.Experience with platforms...QualityFull timeContract workSummer workFlexible 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... ..., Analytical Development, Production, Quality Assurance can be considered)....QualityMinimum wageTemporary workLocal areaRemote workWorldwide- ...Position Overview: Reporting to the Director, Product Development, the Associate Director, Analytical Development is responsible for... ...-functional teams, including Quality, Regulatory Affairs, and... ...and manufacturing partners. CMC Regulatory Support Author and...QualityContract workLocal area
- ...well-validated targets.Reporting to the Executive Director of Quality Control, the Director of QC Analytical will lead teams responsible for critical QC Analytical... ...of program developmentCollaborate closely with CMC functions, including Analytical Development and Process...QualityTemporary workWork at officeLocal areaImmediate start3 days per week
$94.6k - $141.8k
Job DescriptionGeneral Summary:The Associate Director, GMP Operational Quality Assurance is a Quality leader and advanced technical resource responsible for strategic and operational Quality oversight across multiple complex programs. This role leads day-to-day quality...QualityFull timeContract workSummer workRemote workFlexible hours2 days per week$167k - $300.7k
The RoleCMC is seeking a dynamic and experienced Director, CMC Stability to lead an end-to-end stability function spanning non... ...operating models, develop talent, and influence across Analytical Development, Quality, Regulatory CMC, Manufacturing, MS&T, Clinical Supply, Commercial...QualityPermanent employmentFull timeWork at officeWork from home$110.2k - $193.5k
...you passionate about Human Resources and Analytics? If so, we have an exciting opportunity... ...global Human Resources organization as the Director of Workforce Analytics! In this role,... ...provide leadership to the team to ensure high quality, sophisticated analytic results that...QualityFull timeH1bWork at officeRemote workWork from homeVisa sponsorship1 day per week- ...platforms and tools. Ensures complete data quality coverage, Service Level Agreement (SLA)... ...research processes.Translates analytics into model construction, factor definition... ...equivalent) and six (6) years of experience as a Director, Portfolio Analytics (or closely related...QualityFull timeWork at office
$167k - $300.7k
The Role:Moderna is seeking a Director, Analytical Chemistry to provide scientific, strategic, and organizational leadership for discovery-stage... ...research. The leader will help define decision-quality analytical packages, ensure alignment of analytical deliverables...QualityPermanent employmentFull timeWork at office$230k - $316k
About This RoleThe Sr Director, Insights and Analytics Lead, will support the Neuropsychiatry/Women’s Health franchise by objectively defining and... ...intelligence, brand analytics, and field analyticsDeliver high quality ad hoc analyses to leadership that offer clear...QualityFull timeTemporary workLocal area$156.6k - $234.8k
...Job DescriptionGeneral Summary:The Associate Director, GMP Operational Quality is responsible for oversight of team activities, development of personnel and ensuring quality of deliverables within department purview. The incumbent has comprehensive knowledge of principles...QualityFull timeWork experience placementSummer workRemote workFlexible hoursDay shift2 days per week$235k - $285k
...Team culture thrive. Join us as a Senior Director, CMC Technical Lead , and you’ll be part of... ...nonclinical, formulation, process and analytical development, manufacturing and regulatory... ...and attention to detail to ensure high quality presentations and regulatory...QualityTemporary workLocal area$175k - $200k
...Facebook.Role Summary:The Associate Director, QA Operations serves as the QA... ...and continuous improvement of Quality Systems, procedures, policies, and metrics supporting GMP activities. Provides leadership... ...programsCollaborates with CMC, Regulatory Affairs, and Project...QualityContract workWork experience placementLocal areaFlexible hours$162k - $223k
About This Role The Field Analytics and Reporting Lead will be responsible for key field analytics projects, KPI and reporting design including... ...key insights.Who You AreYou are driven to execute with high quality, and you communicate effectively. You enjoy being involved in...QualityFull timeTemporary workLocal area- 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...QualityFull timeSummer workRemote workFlexible hours2 days per week
$150k - $211k
...Manufacturing Science and Analytical Technology (MSAT)... ...manufacturing robustness, quality, and compliance across... ...SummaryReporting to the Director of Drug Substance (Biologics... ...from MSAT, QA, QC, CMC, External Manufacturing... ...strategies align with GMP, ICH, and global regulatory...QualityTemporary workRemote workWorldwideFlexible hours$148.5k - $214.5k
Job Title: Associate Director, US Consumer AnalyticsLocation: Cambridge, MA or Morristown... ...Associate Director, US Consumer Advanced Analytics, will be responsible for applying data,... ...to ensure robust data infrastructure and quality. Coordinate with agency and vendor...QualityFull time$165k - $190k
...therapeutics for patients in need. Iterative Health is looking for a Director of Analytics to own how we define, measure, and improve performance... ...best practices Champion data governance, documentation, and quality across the analytics function Hire and develop a small...Quality- ...Job Description Full time/dedicated responsibility for CMC leadership and project management for commercial and pipeline... ...with small molecule products manufacturing, development, quality and analytics is required. Knowledge and experience with FDA and global...QualityFull timeLocal area
$166.4k - $249.6k
...DescriptionGeneral Summary:The Chemistry Manufacturing Controls (CMC) Associate Director leads and executes global regulatory CMC strategies across... ...accountable for authoring, reviewing, and delivering high-quality regulatory submissions, while serving as the primary CMC...QualityFull timeSummer workRemote workFlexible hours2 days per week$142.5k - $256.5k
The Role:The Associate Director, Global Regulatory-CMC will be responsible for coordinating regulatory CMC... ...for preparation of CMC and Quality related agency correspondence and regulatory... ...Manufacturing, Quality and Process/Analytical Development groups regarding their applicability...QualityPermanent employmentFull timeWork at officeWork from home$129k - $203.1k
...data to enhance insights, efficiency, and quality of DSCS processes and methods. DSCS... ...critical data assets across the Pharmaceutical CMC (Chemistry, Manufacturing, and Controls)... ...submissions and inspections, advanced analytics, machine learning, predictive modeling, and...QualityFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work
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