Scientist/Sr. Scientist, LNP Analytical Development

2 months ago

Cambridge, Massachusetts, United States Beam Therapeutics Full time

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.

  • Scientist/Sr. Scientist, LNP Analytical Development

    3 weeks ago

    Cambridge, Massachusetts, United States Beam Therapeutics Full time

    Company OverviewBeam Therapeutics is committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform that includes a suite of gene editing and delivery technologies and is in the process of building internal manufacturing capabilities. Beam's suite of gene editing...

  • Scientist / Sr. Scientist - Large Molecule Product Development

    1 month ago

    Cambridge, Massachusetts, United States Eli Lilly and Company Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Scientist, Analytical Development

    1 month ago

    Cambridge, Massachusetts, United States Adaptimmune Full time

    Adaptimmune is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immunotherapy products for people with cancer. The Company's unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors.Our company...

  • Principal Associate Scientist: Analytical Development

    1 month ago

    Cambridge, Massachusetts, United States Proclinical Full time

    Principal Associate Scientist for Analytical Development - Contract - Cambridge, MA Proclinical is actively seeking a Principal Associate Scientist. This is a temporary contract position based in Cambridge, Massachusetts, MA. Primary Responsibilities:This role is primarily focused on the initial characterization testing, annual re-qualification, and trending...

  • Process Development Sr Principal Scientist

    1 month ago

    Cambridge, Massachusetts, United States Amgen Full time

    HOW MIGHT YOU DEFY IMAGINATION?If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better...

  • Scientist I/II, CMC Analytical Development

    4 weeks ago

    Cambridge, Massachusetts, United States PepGen Full time

    Scientist I/II, Analytical DevelopmentPosition Summary The Scientist, Analytical Development/CMC will be a key member of the Analytical Development group at PepGen. The successful candidate will have great opportunities to use state-of art instruments for studying various potential drug candidates to ultimately create transformational therapies for patients...

  • Associate Scientist

    1 month ago

    Cambridge, Massachusetts, United States Generation Bio Full time

    Generation Bio is innovating genetic medicines to provide durable, redosable treatments for people living with rare and prevalent diseases. The company's non-viral platform incorporates a novel DNA construct called closed-ended DNA, or ceDNA; a unique cell-targeted lipid nanoparticle delivery system, or ctLNP; and a highly scalable capsid-free manufacturing...

  • Process Development Principal Scientist Analytical Chemist

    1 month ago

    Cambridge, Massachusetts, United States Amgen Full time

    HOW MIGHT YOU DEFY IMAGINATION?If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products...

  • Lead Scientist

    6 days ago

    Cambridge, Massachusetts, United States Gilder Search Group Full time

    Lead Scientist - Nucleic Acid ResearchCompany: Gilder Search GroupOur client is a prominent organization in the chemical manufacturing sector, seeking to establish a new team of experts specializing in Nucleic Acid technologies. This position is crucial for assembling a highly effective and collaborative group of Subject Matter Experts (SMEs) in the rapidly...

  • Senior Analytical Scientist

    5 days ago

    Cambridge, Massachusetts, United States GlaxoSmithKline Full time

    Position Overview:The Senior Analytical Scientist will spearhead the design and execution of scientific investigations to support technical initiatives as they transition from preliminary development through various phases of clinical trials and into commercial readiness.This role demands expertise in cutting-edge analytical methodologies for macromolecule...

  • Associate Formulation Development Scientist

    1 month ago

    Cambridge, Massachusetts, United States Proclinical Full time

    Associate Formulation Development Scientist - Contract - Cambridge, MAProclinical is seeking a dedicated and innovative individual for the role of Associate Formulation Development Scientist. Primary Responsibilities:The successful candidate will be responsible for the formulation and process development of drug products, with a focus on vials and prefilled...

  • Senior Scientist, Oligonucleotide Process Sciences

    1 month ago

    Cambridge, Massachusetts, United States Intellia Therapeutics Full time

    Why Join Intellia?Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to...

  • Process Development Senior Principal Scientist

    3 months ago

    Cambridge, Massachusetts, United States Amgen Full time

    HOW MIGHT YOU DEFY IMAGINATION?If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better...

  • Lead Scientist, Viral Therapeutics

    5 days ago

    Cambridge, Massachusetts, United States Flagship Ventures Full time

    Company OverviewWhat if...you could be part of an organization that pioneers, funds, and develops life sciences enterprises focused on groundbreaking technologies aimed at revolutionizing health care and sustainability? Prologue Medicines is committed to redefining drug discovery by utilizing profound biological insights and state-of-the-art scientific...

  • Lead Scientist, Biomolecular Characterization

    6 days ago

    Cambridge, Massachusetts, United States The University of Texas MD Anderson Cancer Center Full time

    Position Title: Lead Scientist, Biomolecular CharacterizationLocation: United StatesPosition Overview:In this role, you will spearhead the biomolecular analysis to facilitate platform innovation and ensure product quality control. Your primary focus will be on the development of bioanalytical assays to evaluate mRNA integrity, capping efficiency,...

  • Lead Process Engineer, LNP Production

    5 days ago

    Cambridge, Massachusetts, United States Intellia Therapeutics, Inc. Full time

    Why Choose Intellia Therapeutics, Inc.? At Intellia, our mission is to pioneer transformative genome editing therapies that can significantly improve the lives of individuals facing severe and life-threatening conditions. We are guided by our core values: One, Explore, Disrupt, Deliver. We believe that together, we can achieve extraordinary outcomes. Our...

  • Senior Process Engineer I, LNP Manufacturing

    1 month ago

    Cambridge, Massachusetts, United States Intellia Therapeutics Full time

    Why Join Intellia?Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to...

  • Sr. Scientist, Discovery DMPK

    1 month ago

    Cambridge, Massachusetts, United States FogPharma Full time

    Why join us?FogPharma is a biopharmaceutical company pioneering the discovery and development of HeliconTM therapeutics, which are peptides capable of efficient cell entry and modulation of both protein-protein and protein-DNA interactions. Through Helicon therapeutics, FogPharma is poised to revolutionize the medical possibilities for patients by precisely...

  • Process Development Associate Scientist

    2 months ago

    Cambridge, Massachusetts, United States Amgen Full time

    HOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...

  • Associate Director, Analytical Development

    2 weeks ago

    Cambridge, Massachusetts, United States Adaptimmune Full time

    Adaptimmune is a fully integrated cell therapy company, designed and built from the ground up with four U.K.- and U.S.-based biotechnology hub locations. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and allogeneic manufacturing, and in-house commercial and corporate...