Average salary: $166,664 /yearly
More stats ...Research and Development, Global Study Management and Monitoring (GSMM), Project Management, Affiliates, Medical Affairs (MA), Regulatory, CMC, QA, Packaging Vendors, CRO's, IRT Organizations, and Global Clinical Supply Chain Functional Operations to ensure all needs are met....
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...Network Manufacturing Science and Technology (MS&T) group within CTTO plays a critical role in technology transfers, process validation, CMC life cycle management, technical oversight of external manufacturing partners, process engineering and establishing manufacturing...
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...work and in their personal lives. Read more: careers.bms.com/working-with-us .
Our Drug Product Development team is committed to CMC design, development, and commercialization of innovative drug products to improve patient lives. We leverage the best people, collaboration...
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...Development, Global Study Management and Monitoring (GSMM), Project Management, Client Affiliates, Medical Affairs (MA), Regulatory, CMC, QA, Packaging Vendors, CRO's, IRT Organizations, and Global Clinical Supply Chain Functional Operations to ensure all needs are met....
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...relationships with regional health authorities and other external partners.
Maintain collaborative relationships with respective GPS, GRA CMC and other GRAST members to help develop assigned products/projects.
Works with Global Regulatory Therapeutic Area Leads and their...
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$78.12 - $130.21 per hour
...the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.
Join Takeda as a Director, GRA CMC Pharmaceuticals, Oligonucleotides where you will lead the GRA CMC Pharmaceuticals regulatory team in the development and...
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...lab method support & troubleshooting, method validations & transfers, lifecycle method monitoring & remediation; as well as analytical CMC strategy supporting product globalization. This work involves managing the analytical sections of the world-wide dossiers, authoring...
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$133.2k - $223.2k
...of my knowledge.
Job Description
Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC in Cambridge, MA with the following requirements: Master’s degree in Regulatory Affairs or related field plus 2 years of related experience...
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$138.5k - $186k
...of my knowledge.
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Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC Submissions Management in Lexington, MA with the following requirements: Bachelor’s degree in a scientific field or foreign academic...
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...particularly in the pharmaceutical, vaccine, or biological products industry. The primary responsibilities of this role include performing CMC compliance activities, authoring assessment reports, and leading global product regulatory strategies. The Data Analyst will also...
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...providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Summary
CMC Lead is responsible for supporting the overall CMC strategies within projects, and manage project teams. The project teams will be...
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$98.96 - $156.25 per hour
...colleagues in quality and commercial organizations to manage pipeline products and bring current products to industry standards.
Represent CMC and GRA on key governance committees and play a critical role in driving the organization towards innovative approaches for the...
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...responsibilities:
The leader will advance the purpose and aspiration of our Company's digital (Chemistry, Manufacturing, and Controls) CMC program to set the foundation for a digital continuum from development to manufacturing for our products and processes. The digital...
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$78.12 - $130.21 per hour
...worldwide.
Join Takeda as a Senior Director, GRA Pharmaceuticals- Small Molecule where you will establish collaboration with Global CMC teams and leadership through networks and enable CMC regulatory team’s success in meeting goals/objectives. You will also influence...
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...Twix card. Able to pass DOT physical
Arxada has world class offering in three distinct areas:
Consumer Microbial Control (CMC) focuses on the threat posed by microorganisms to people, with products spanning the food and drink, professional hygiene, home and personal...
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...and antibody protein drug to accelerate drug development for customers. GenScript ProBio's total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing. In terms of plasmid service,...
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...Quality, Technology, Analytical, Commercialization and Operations), as well as our Research & Development Division Process, Analytical and CMC Regulatory groups.
* Defines, assesses, and presents business analyses for potential transactions requiring manufacturing input....
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3 days per week
...clinical studies, life-cycle management, generic/505b2 product evaluation and development, technical transfers, and pharmaceutical QA/CMC is desired.
What We Offer*:
* Annual performance bonus, commission, and share potential
* Auto enrollment in a Hikma-sponsored...
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...and antibody protein drug to accelerate drug development for customers. GenScript ProBio's total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing. In terms of plasmid service,...
...and antibody protein drug to accelerate drug development for customers. GenScript ProBio's total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing. In terms of plasmid service,...
Full time
...Strongexpertise in Pharma Manufacturing or MedTEch Manufacturing
o Sufficientexperience in driving IT/OT convergence.
o Expertisein CMC, PD and /or Quality Desirable
o Experiencein Cell & Gene Therapies/mRNA desirable
o Niceto have experience in the area of...
...and antibody protein drug to accelerate drug development for customers. GenScript ProBio's total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing. In terms of plasmid service,...
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...overall project plans.
Partners with and provides subject matter expertise to key internal functions (regulatory, Quality, Clinical, CMC and formulations, Product Quality, Drug safety, Medical affairs) and their external contractors or collaborators.
Contributes to...
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...Neurology or Oncology therapeutic areas
•Advanced understanding of the drug development plans, preclinical toxicology, toxicology, CMC, regulatory and other development requirements as they relate to efficient execution of the development plans.
•Advanced understanding...
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Pay rate range: $45-48/hr.
Job Description:
Well versed in performing CMC compliance activities including Gap Analysis, CMC comparison and validation for the quality reports
· Experienced in authoring of assessment reports and Part2/ Expert reports for Dossiers...
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...rare diseases and immune disorders.
Summary
The Associate Director, RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small molecule and biological drug products consistent with the...
...to partner closely with teams and senior leaders from across Regulatory Affairs, as well as cross-functional stakeholders (e.g., RA CMC, R&D Excellence, Clinical Operations, IT).
Responsibilities
Operate within and in support of the established RD data governance...
...includes integrating strategic and tactical input from diverse disciplines (e.g., clinical, regulatory, market access, manufacturing, CMC, commercial, and other areas) as applicable to the project.
+ Building and maintaining project schedules and critical project...
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3 days per week
...that leads to excellent clinical outcomes. All of the medical centers are designated Stroke Centers by the Joint Commission, with MMC, CMC, NMC, and HMC designated as Primary Stroke Centers and OMC being designated as a Comprehensive Stroke Center, providing diagnostics...
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...thorough understanding of Business Processes, KPIs, Challenges, and Industry Trends and Regulations
•Nice to have: Experience in CMC
•Has experience with IT enablement and business transformations, and holistic knowledge of Business and IT Landscape for the...
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