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The Director, CMC Operations responsible for technically designing, managing, and executing a plan for the use of alpha emitting Pb-203 & Pb-212 radiopharmaceuticals and the manufacturing of drug candidates supporting clinical trials and readiness for commercial...
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Associate Director, CMC Lead in Basking Ridge at Daiichi Sankyo Join a Legacy of Innovation 110 Years and Counting!
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified,...
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Associate Director, Global Regulatory Affairs CMC page is loaded
Associate Director, Global Regulatory Affairs CMC
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locations
Copenhagen
time type
Full time
posted on...
Suggested
Full time
Remote job
Worldwide
...Clients s US Regulatory electronic document management system.
ORGANIZATION STRUCTURE
The Senior Associate, Regulatory Operations/CMC reports into the Manager/ Director, Regulatory Affairs and is based in Morristown, New Jersey.
RESPONSIBILITIES
Primary...
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...represents several leading manufacturers, including:
# Bandit Industries
# Sennebogen
# Hyundai Construction Equipment
# Giant
# CMC Lift
#
Your Role:
#“Tow and Show”: Your day-to-day duties involve safely operating a 1-ton pickup while towing equipment....
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Monday to Friday
...as outreach events.
WORK ENVIRONMENT
# The employee is not substantially exposed to adverse environmental conditions.
CMC Energy Services, Inc. provides equal employment opportunities to all qualified individuals without regard to race, creed, color,...
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Full time
For contractors
Local area
Flexible hours
Shift work
Weekend work
...installing energy-saving measures as determined by program or contract. This individual will maintain a safe working environment for CMC employees and customers at all times, providing a high level of customer service and education for each service or installation performed...
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Contract work
For contractors
Immediate start
Outdoor
...’s drug development programs, policies and procedures; ensuring a compliant state of regulatory commitment. Ensures that appropriate CMC regulatory activities occur in support of both pre and post-approval submissions while meeting aggressive timelines and adhering to the...
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...areas.
This role will ensure commercial leadership for pipeline products, partnering closely with Development, Medical, Regulatory, CMC, Commercial, and Project Leadership to optimize overall development strategy, brand development, and market preparation for pipeline...
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Local area
Remote job
Worldwide
Shift work
...implementation of regulatory strategies for assigned programs and ensures cross-functional alignment.
Coordinates regulatory activities (CMC, nonclinical, and clinical) to assure timelines and milestones.
Supports departmental activities with regards to clinical trial...
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Contract work
For contractors
...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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...and transfer of analytical methods of biologics drugs (including monoclonal antibodies, bispecific antibodies, Client).
• Understand CMC process of biologics drugs, and operation specification for QC and QA.
• Understand the quality requirement of biologics drugs application...
Suggested
Full time
Work experience placement
...Manager leads the administration, design, implementation, and support of ERP applications (NetSuite) throughout Finance and Accounting, CMC\Tech Ops, Quality, Procurement, IT and enabling functions. This is an IT technical role and will manage enterprise applications,...
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...Functions
Operations
Strategy
Known Requirements
Bachelor’s degree in a scientific discipline required
Strong oncology experience required
In-depth knowledge of relevant regulatory guidelines and requirements required
Regulatory CMC and CDx expertise required
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...and administrative leadership of technology transfer and GMP manufacturing of medical devices at the Collagen Manufacturing Center (CMC). This role is also responsible for multidisciplinary process selection, optimization activities, troubleshooting, and ongoing Process...
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...cross-functional oncology drug development team with working knowledge across multiple R&D functions (preclinical, clinical, regulatory, CMC)
Clinical development experience required; late-stage clinical experience is preferred
Hands on BLA/NDA submission experience is...
Temporary work
Fixed term contract
Remote job
...Role & Department
Genmab is now searching for an experienced Senior IRT/Systems Manager to be part of Global Clinical Drug Supply, CMC Operations, and work according to our hybrid work arrangement in Princeton, NJ.
Responsibilities
Act as Senior IRT Manager,...
Fixed term contract
...Accommodations team at
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...Prepare and submit regulatory submissions using eCTD software, publishing tool to FDA.
Author, compile and review technical documents (CMC) for accuracy and acceptability in New Applications (i.e. ANDAs or NDAs], Amendments, Supplements, PADER, Annual Reports and other...
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