BioSpace · 1 day ago

Senior Scientist I, Biologics Preformulation

Massachusetts, United States

Full-time

Remote

Mid, Senior Level

1+ years exp

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Responsibilities

Designs experiments and strategies to efficiently evaluate physicochemical and biophysical properties of discovery biologic molecules and to identify liabilities that could impact product development. Develops characterization methods for diverse classes of biologics (e.g., antibody, antibody-drug conjugate, bispecific antibody, fusion protein, mRNA-LNPs and conjugates). Selects drug candidates with desired characteristics for further drug product development.

Serves as project lead for the Preformulation team, interacting with members from discovery and development groups to optimize the screening and selection of discovery candidates. Learns about diverse therapeutic areas and new biologic initiatives to foster effective collaborations with multiple teams.

Uses advanced knowledge of formulations, biophysics, biochemistry, and CMC to streamline development of new biologics. Takes initiative to pursue innovative research ideas.

Assay development for analytical characterization of mRNA-LNPs and protein drug modalities.

Drafts technical documents and patent applications. Writes manuscripts for publication in peer-reviewed journals. Attends external conferences for professional development.

Mentors colleagues and helps maintain a highly collaborative and transparent work environment. Emphasizes efficient work habits and detailed attention to data documentation. Manages product timelines and resources.

Executes a strong laboratory-based workplan to achieve results with minimal direction from supervisor. Maintains laboratory equipment and seeks cutting-edge methods and instruments to advance goals.

Qualification

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. in BiochemistryMRNA-LNP characterizationAssay developmentAnalytical characterizationBiophysicsBiochemistryProtein formulationNano flow-cytometryTapeStationRiboGreen assayELISABiolayer interferometryDdPCRSEC-MALSDLSLiquid chromatographyMass spectrometryUV-VIS absorbanceFluorescence spectroscopyDifferential scanning calorimetryFluorimetryImaged capillary isoelectric focusingDynamic light scatteringCapillary electrophoresisGel electrophoresisHigh-throughput methodsAntibodiesProtein therapeuticsAntibody-drug conjugatesLipids

Required

Highly motivated Ph.D. (+ 1-4 years of experience) or M.S. (+6-10 years of experience) in Biochemistry, Biophysics, Pharmacy, Biopharmaceutics, or related discipline with strong laboratory and technical expertise in evaluation of physicochemical properties of mRNA-LNPs, biologics, drug product formulations, and bioassays.

Demonstratable record of assay development and analytical characterization of mRNA-LNPs.

Experience with nano flow-cytometry.

Prior experience characterizing mRNA-LNPs with TapeStation, RiboGreen assay, ELISA, Biolayer interferometry, ddPCR, SEC-MALS, and DLS.

Advanced knowledge and experience in protein physicochemical techniques, biological assays, biochemistry, organic chemistry.

Detailed familiarity with protein analytical methods including liquid chromatography (SEC, ion-exchange), mass spectrometry, UV-VIS absorbance and fluorescence spectroscopy, differential scanning calorimetry and fluorimetry, imaged capillary isoelectric focusing (icIEF), dynamic light scattering, capillary electrophoresis, gel electrophoresis. Experience with high-throughput methods and automation.

In-depth knowledge of protein formulation and solution biophysics such as viscosity and thermal stability measurements. Willing to learn new technologies and knowledge areas as needed.

Detailed knowledge of antibodies, protein therapeutics, antibody-drug conjugates (ADCs), lipids, nucleic acids, gene therapy. Experience in conducting and interpreting bioassays is desired.

Excellent communication skills. Demonstrated proficiency in writing technical documents and publications. Track record of innovation.

Laboratory operation and organizational skills are highly desired.