Search Results: 21 vacancies
...Development Committee level driving joint decisions for the development programs. Key member of Asset Strategy Team (AST) and ensures CMC strategy is closely aligned with the clinical and regulatory development strategy. May lead multiple PPDST/CMC teams from GLP tox...
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...Target PR Range: 30-40/hr
*Depending on experience
Individual is responsible for ensuring RA-CMC post approval change objectives are met by project managing marketed product variations including authoring and compilation of chemistry, manufacturing, and control (...
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...Collaborate with scientific support from other CPPM functional groups to provide unified clinical pharmacology position to clinical, CMC & regulatory teams. Author scientific publications & present at scientific conferences.
Qualifications
Must possess PhD or foreign...
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...-day decision making for the asset(s).
+ Accountable for leading a cross-functional asset team(s) including a medical, regulatory, CMC, research, operations, commercial, finance and data science to advance one or more assets from preclinical candidate nomination through...
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...and Development organization. This role is primarily responsible for managing the operational and financial aspects of the Biologics CMC Development organization. This position will collaborate with functional leadership to plan projects and execute activities that align...
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...diseases.
AbbVie Analytical Research & Development (Analytical R&D) is a global analytical sciences organization responsible for all CMC analytical activities related to the development of AbbVie's pharmaceutical products. Our scope includes AbbVie's diverse pipeline of...
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...technology resulting in a cost-effective commercial manufacturing process. We develop the supply chain for APIs, prepare and defend CMC (Chemistry, Manufacturing and Control) regulatory content.
We seek a highly motivated scientist with strong synthetic skills to work...
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...Drives small teams with members from Pharmacometrics functional groups to provide a unified modeling and simulation position to clinical, CMC and regulatory teams.
+ Responsible for the appropriateness, quality and accuracy of pharmacometrics deliverables. Advice on...
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...culminating in drug substance and may have supervisory responsibilities. The candidate will serve as the chemistry representative on the CMC team for ADC development programs and as such would be responsible for developing timelines and executing activities required for...
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...Strategy Teams to advance preclinical and clinical candidates. It is expected that the candidate will utilize their expertise across CMC disciplines to generate collaborations with drug product development and regulatory affairs to further program goals.
+ The ideal candidate...
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...Instagram, YouTube and LinkedIn.
Job Description
Purpose: Oversee process for management of external finances in support of CMC product development strategies. Oversee contract-tracking system to ensure contracts are completed within time. Work with Product Development...
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...qualification and transfer to QC, and execution of analytical methods to provide product and process understanding, as well as analytical CMC program management forLocation: Anywhere; Core hours: 9 am 3 pm ETResponsibilities:Generate document templates for Analytical...
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...Strategy Teams to advance preclinical and clinical candidates. It is expected that the candidate will utilize their expertise across CMC disciplines to generate collaborations with drug product development and regulatory affairs to further program goals.
The ideal candidate...
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...related fields. Licensed LVN or RN. Licensure in Social Work highly desired.
Attainment of a Care Management Certification (CCM or CMC) required within the first year of employment.
A minimum of two (2) years’ experience in geriatrics and/or care management...
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...technology resulting in a cost-effective commercial manufacturing process. We develop the supply chain for APIs, prepare and defend CMC (Chemistry, Manufacturing and Control) regulatory content.
We seek a highly motivated scientist with strong synthetic skills to...
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...packaging and/or testing.
Core team member representing QA on including Pipeline Teams, New Product Introductions, Governance Process, CMC Leadership Team, Product Transfers, Global Strategic Sourcing, Due Diligence, and Site Selection. Make primary decisions on product...
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...Company Description
AbbVie Analytical Research & Development (ARD) is a global analytical sciences organization responsible for all CMC analytical activities related to the development of AbbVie's pharmaceutical products. Our scope includes AbbVie's diverse pipeline of...
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...Instagram, YouTube and LinkedIn.
Job Description
The Molecular Profiling and Drug Delivery (MPDD) function within the Small Molecule CMC organization is accountable for a broad range of deliverables across various stages of drug discovery and development. During lead...
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...development programs.
Trains, develops, and manages an effective regulatory affairs cross-functional team on key labelling requirements (CMC, Regulatory Operations, US Labeling and Advertising and Promotion, International regulatory).
REQUIRED EDUCATION, EXPERIENCE...
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...AbbVie Biologics Analytical Research & Development (Biologics ARD) is a global analytical sciences organization responsible for all CMC analytical activities related to the development of AbbVie's therapeutic biologic products. Our scope includes AbbVie's diverse pipeline...
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