Pharmalink Consulting is recruiting for a Regulatory Submission Manager who will coordinate all aspects of CMC regulatory submissions relevant to their assigned projects and serve as the regulatory CMC representative on matrix teams, as appropriate.
Duties and Responsibilities:
Monitor changes to development plans and work with supervisor to design globally compliant CMC regulatory strategy for development products with supervision.
Drive global CMC regulatory submission activities (IND, CTA, ...
Responsible for input including: documentation, application forms, regulatory submissions (briefing documents/INDs BLAs/Post Marketing submissions, etc.)
Prepares and reviews local labels.
In consultation with Sr. Managers, contributes to regulatory interactions with local health authorities in the US and Canada.
Provides input into the development of regional RA strategies.
Monitors local guidelines and vaccine specific recommendations.
Prepares and/or comments on ...
The candidate will be responsible for conducting in-vitro and in-vivo studies, analyzing metabolites from a variety of matrices and interpret MS/MS data in support of discovery and early development projects. The scientist will use-state-of-the-art mass spec and other analytical technologies. This position requires a BS/MS in Chemistry/Biochemistry and related discipline with 1-5 years of experience in the pharmaceutical industry performing in vitro biotransformation studies, experience with use of ...
our client in cambridge, ma is looking for an associate scientist with redox potentiometric experience. This is a long term consulting position. If interested, please apply to this ad
Job #: 13-01484
job title: Associate Scientist, Redox Potentiometric measurements
The candidate will support application of redox potentiometric measurements for development of analytical tools to monitor the oxidation of polysorbates and therapeutic proteins. Primary responsibilities include method development, ...
Contact Amanda at 815-756-1221 for more details
The R&D Scientist will be responsible for working cross functionally with consumer insights, marketing, engineers, and scientists to launch new innovative products. This role will be lead in product development from concept to commercialization.
- BS Food Chemistry
- 3+ years of experience in the food and beverage industry
- Proficient in Word and Excel
- Data and project management skills
- Problem solving and analysis skills
PS Order #: 92749
Title of Position: Quantitative Protein Biomarker Scientist
Location: City/State: Andover, MA
Contract Length: 12months
Target Start Date: 11/25
Qualifications, Technical Skills and Experience: • BS/MS level education in biochemistry, biology or chemistry or related fields required; advanced degree may be a plus. • Industry experience in biopharma preferred. • Extensive expertise in the operation and maintenance of mass spectrometers. • Experience with basic ...
• Responsible for input including: documentation, application forms, regulatory submissions (briefing documents/INDs BLAs/Post Marketing submissions, etc.)
• Prepares and reviews local labels.
• In consultation with Sr. Managers, contributes to regulatory interactions with local health authorities in the US and Canada.
• Provides input into the development of regional RA strategies.
• Monitors local guidelines and vaccine specific recommendations.
• Prepares and/or comments ...
We are looking for a mechanically skilled candidate to maintain our fleet of open access LC-UV-MS-ELSD analytical and prep instruments. You will be part of an Open Access Engineering team supporting Chemists and Biologists for their open access sample analyses. Training will be provided, as needed.
• Act as the primary support engineer for instrumentation within the Open Access labs of our Analytical Sciences and Chemistry departments in Cambridge, MA.
• Keep instruments running at ...
Oct 29 -
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