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Beam Therapeutics
Cambridge, MA, United States
Position Overview: Beam is seeking a principal scientist with expertise in nanoparticle process and formulation development. In this role, the individual will work closely with the Discovery, Technical Development, Manufacturing and Analytical groups to advance our early pipeline into development.The candidate will work on formulation and scale up
Job Source: Beam TherapeuticsCRISPR Therapeutics
Boston, MA, United States
Company Overview Since its inception over a decade ago,CRISPR Therapeuticshas transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and r
Job Source: CRISPR TherapeuticsCRISPR Therapeutics
Boston
Job Description Job Description Company Overview Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, rege
Job Source: CRISPR TherapeuticsScorpion Therapeutics
Boston, MA, United States
Job Summary: Scorpion Therapeutics is seeking a highly skilled and motivated Senior Scientist, Analytical Development to join our CMC team. The Senior Scientist will play a key role in advancing our pipeline of novel cancer therapeutics by leading the development and implementation of analytical methods to characterize drug candidates and support
Job Source: Scorpion TherapeuticsBeam Therapeutics
Cambridge, MA, United States
Position Overview We are seeking a motivated Scientist/Sr. Scientist to join our Analytical Research and Development team and perform method development and qualification for lot release and characterization of cell and gene therapy products and critical materials. S/he will work with a Beam’s Analytical Development team to enable the rapid advanc
Job Source: Beam TherapeuticsThe University of Texas MD Anderson Cancer Center
Boston, MA, United States
Job Title: Sr. Scientist, Analytical Job Number: 34039 Location: Boston, MA Job Description We are seeking an Analytical Development Bioassay Scientist to be responsible for developing cell-based and ELISA potency assays for product testing/characterization for our clients Boston-based lab. This individual will be an important member of the
Job Source: The University of Texas MD Anderson Cancer CenterModerna Therapeutics
Norwood, MA, United States
Scientist, Analytical Development page is loaded Scientist, Analytical Development Apply locations Norwood, Massachusetts Technical Development time type Full time posted on Posted Yesterday job requisition id R15612 The Role Moderna is seeking a talented and motivated Scientist with a strong background in An
Job Source: Moderna TherapeuticsModerna Therapeutics Inc.
Norwood, MA, United States
The Role Moderna is seeking a talented and motivated Scientist with a strong background in Analytical Chemistry. This individual will primarily work with analytical and process teams on stability studies for early to late phase mRNA-Lipid Nanoparticles (LNPs) based vaccines and therapeutics. The responsibilities will include participating in stabil
Job Source: Moderna Therapeutics Inc.Cambridge, MA, United States
Position Overview
We are recruiting a Scientist/Sr. Scientist with experience in phase-appropriate analytical method development, optimization, and qualification of physicochemical assays for lot release, stability, and characterization of cell and gene therapy products to support Beam’s in vivo programs using lipid nanoparticle (LNP) delivery. In this lab-based role, the Individual will work in Beam’s LNP platform analytical team and lead analytical efforts in developing early to late phase control strategy and methods for LNP products. The ideal candidate will have experience in design and development of analytical methods for mRNA, gRNA, lipids, and LNP, experience working collaboratively with cross-functional CMC teams and external testing labs, and have a working knowledge of analytical ICH/USP guidelines.
Primary Responsibilities:
Early through late phase method development, optimization, and transfer for lot release, stability, and characterization of cell and gene therapy products and critical materials, such as gRNA, mRNA, lipids, and LNP.
Establish technical leadership as SME in multiple analytical techniques during method development and transfer and provide technical troubleshooting support when needed.
Work with cross-functional groups including Research & Development, QC, and Process Development teams to participate in various aspects of method development, transfer, characterization, comparability, and investigation.
Coordinate routine sample testing including requests from Process Development, Research and Development groups, and external vendors.
Author and review SOPs, technical reports, and assist in the preparation of CMC regulatory submissions.
Analyze, track, and trend data to monitor analytical assays and ensure consistency in assay performance.
Maintaining detailed documentation of experiments in ELN system.
Adapting to a fast-paced, dynamic research environment.
Mentor and train junior scientists, with the potential to manage a small team of analytical scientists.
Living Beam Therapeutics core values of being part of a community of fearless innovators, being rigorous and honest in our research, listening with open minds, and committed to each other.
Qualifications:
Degree in a relevant discipline (biochemistry, biotechnology, biological sciences, bioengineering, or related fields). Minimum PhD with 2+ years or BS/MS with 10+ years (title based on experience) industry experience including biotech, biopharma, CRO, CDMO.
Must have hand on experience on analytical method development, optimization, qualification, and testing at GMP or non-GMP environments, supporting clinical phase programs.
A good understanding of ICH Q2 and Q14, with working knowledge on analytical Quality by Design concept.
Experience with analysis of RNAs, lipids, and lipid nanoparticles (LNPs) is highly desirable and will be key to the success in this role.
Extensive experience with at least one or several of the analytical techniques is required: HPLC (IPRP, SEC, IEX), capillary gel electrophoresis, fluorescence-based RNA quantitation. Experience with qPCR, DNA and RNA extraction, ELISA, western blotting, UV spectrophotometry, DLS, MALS, mass spectrometry, and compendial testing will be a plus.
Experience on analytical CMC development, method transfer, stability programs, and CRO management is highly desirable.
People management and CMC project management experience will be a plus.
Familiarity with data analysis software such as Empower, Openlab, Chromeleon, and statistical software such as JMP. Experience with LIMS system.
Team player with excellent oral and written communication skills.
Independently motivated, detail-oriented scientist with excellent critical thinking and problem-solving abilities.
Excellent organizational skills towards multi-tasking in an extremely fast-paced environment with changing priorities.
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Scientist/Sr. Scientist, LNP Analytical Development jobs in Cambridge, MA, United States
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