• Principal Scientist, Biophysical Characterization

    Location US-NJ-Piscataway
    Posted Date 4 months ago(7/12/2018 11:49 AM)
    ID
    2018-2175
    Company
    Adello Biologics, LLC
  • Overview

    Adello Biologics is a privately held, U.S.-based biotechnology company that leads with science to accelerate development and drive manufacturing efficiency. The company's aim is to provide high-quality, affordable biosimilars to patients worldwide. Headquartered in Piscataway, NJ and driven by a team of highly skilled industry veterans, Adello is advancing a strategic pipeline of proteins and complex monoclonal antibodies with lead candidates in oncology and immunology. For more information, visit www.Adellobio.com

     

    Our vision is to make biosimilar medications affordable. We are seeking candidates interested in contributing to a bourgeoning field that has the potential to help millions of patients. As a growing company, Adello Biologics offers real development opportunities for candidates excited to take on responsibility, make an immediate impact and help us achieve our vision. As part of a close knit team, you’ll have the opportunity to work in a unique, high science industry while expanding your career. We are seeking a Principal Scientist, Biophysical Characterization to be based out of our HQ in Piscataway, NJ.

     

    Responsibilities

    Job Responsibilities:

    • Lead efforts related to method development, qualification and validation, including preparation and review of protocols, SOPs and reports.
    • Lead the sample analysis for similarity assessment, formulation and process development, CQA assessment, stability studies, and forced degradation studies.
    • She/he will be responsible for planning, execution, analysis, and reporting of experiments related to the development of primary, secondary, tertiary and higher order structure characterization techniques.
    • Internal expert on data interpretation, applications, instrumentation and trouble shooting.
    • Analyze, summarize, and present experimental results

    Qualifications

    Qualifications & Experience:

    Required:

    • Practical knowledge of methodologies such as DSC, CD, FT-IR, NMR, AUC, DLS/ MALLS, Fluorescence spectroscopy is required.
    • This individual should have demonstrated fundamental knowledge of protein structure and degradation mechanisms including chemical stability, physical stability, interactions with common excipients etc.
    • Strong command over data analysis and fitting of various kinetic and thermodynamic models.
    • Understanding of ICH requirements in relation to characterization method development, qualification & verification.
    • Prior experience in authoring relevant sections of regulatory dossiers and addressing health authority questions.
    • Good conceptual, analytical, problem solving, and organizational skills – must be detail-oriented, and able to work independently and in teams.
    • Excellent communication skills, both verbal and written, and the ability to interface effectively with functional groups.
    • Highly motivated, self-driven individual, well-organized with record-keeping, and adaptable to rapidly changing priorities.

    Preferable:

    • Additional experience with aggregate characterization and sub-visible particle analysis (HIAC, MFI) and mass spectrometry is desirable.

    Ph.D. in Biochemistry, Pharmaceutical Sciences, Chemistry or equivalent with 8+ years of biopharmaceutical industry experience in antibody/protein characterization.

    Adello Biologics, LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Adello Biologics, LLC complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training

     

    Notice To Agency And Search Firm Representatives  

    Adello Biologics is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Adello employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Adello. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

     

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