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Support project team lead to author technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents. Process Development Senior Scientist - Analytical Chemist.
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Examples of our ongoing work can be found at inferencelab.org. The postdoctoral researcher will work extensively on an NIH-funded project related to antenatal steroid administration, lead projects under the PI’s research portfolio, and have the opportunity to write and publish first-author manuscripts with the research team.
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May own CGT standards and author/revise Standard Operating Procedures (SOPs). The Director of R&D Quality, GCP - Cell Gene Therapy (CGT) reports directly to the Head of RDQA and is a trusted advisor and partner to clinical and quality stakeholders and business partners.
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Process Development Scientist - Analytical Chemist. MS or PhD in Analytical Chemistry, Organic Chemistry, Biochemistry, Material Sciences or equivalent. Provide analytical data to support drug substance and drug product development, including purity analysis, chiral purity and structure elucidation using mass spectrometry.
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The postdoctoral associate will author scientific manuscripts, lead grant writing efforts, and present at field-specific conferences. Physicochemical characterization, in vitro and in vivo efficacy testing will be essential in bringing the ocular drug delivery devices to first-in-human clinical trials.
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Author CMC documents for IND and CTA regulatory submissions. PhD/MSc in analytical chemistry, chemistry, radiochemistry, or a related field. Lead the CMC team’s activities as related to the testing of diagnostic and therapeutic radiopharmaceutical drug products and critical raw materials including medical isotopes and precursor materials (peptides, small molecules.
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The laboratory of Dr. Levi N. Kanu of Schepens Eye Research Institute at Massachusetts Eye and Ear is seeking a full-time Postdoctoral Associate for the development and optimization of an ocular drug delivery systems for corneal wound healing.
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The laboratory of Dr. Levi N. Kanu of Schepens Eye Research Institute at Massachusetts Eye and Ear is seeking a full-time Postdoctoral Associate for the development and optimization of ocular drug delivery systems for corneal wound healing.
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PK, dosimetry (radiopharmaceuticals), PK/PD and M&S component of study protocols, reports, project summaries and development plans, and author pharmacokinetic/clinical pharmacology/biopharmaceutics sections/radiation dosimetry of IND/IMPDs and NDA/BLAs as well as prepare appropriate responses to Health Authority questions across the globe.
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Author and review SOPs, technical reports, and assist in the preparation of CMC regulatory submissions. We are recruiting a Senior Research Associate with a good technical background in analytical method development and sample testing for non-GMP lot release, stability, and characterization of cell and gene therapy products to support Beam's in vivo programs using lipid nanoparticle (LNP) delivery.
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4 plus years of experience required to be considered for Senior Principal Scientist level including 2 plus years of experience in a lead role overseeing ADME/DMPK project strategy, either in discovery or clinical development.
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Perform data analysis and author/ review method SOP, assay development summary and report. Scientific training and hands-on experience with various cell-based and molecular assays, including but not limited to 2D and /3D cell culture, cell-based potency assay, ELISA, western, qPCR, RT-qPCR, and DNA/RNA/protein extraction from cells and animal (including NHP) tissues.
$73 an hourFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Author safety signal assessment reports and aggregate safety reports, write and maintain relevant SOPs and procedures in compliance with global safety regulations and guidelines, and provide training within DSPV and cross-functionally.
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Author safety-related documents for Xenon products throughout the product lifecycle from FIH to post-marketing, including Similar Case Analysis, Safety Assessment Reports for potential signals/risks, RSI in IB, ADR in the CCDS and product labels, Aggregate Safety Reports (e.g., DSUR, PBRER, PSUR, PADER), RMP/developmental RMP, and responses to ad-hoc requests for safety information internally and externally.
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The candidate will act as Subject Matter Expert (SME) for synthetic oligonucleotide solid phase synthesis and purification, author appropriate regulatory filings as required, and interface with the Quality unit to resolve quality events in a timely manner.
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author job in Melrose, MA
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