• Director/Senior Director Attribute Sciences

    Location US-NJ-Piscataway
    Posted Date 1 week ago(11/8/2018 4:28 PM)
    ID
    2018-2238
    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 Director/Senior Director Attribute Sciences to be based out of our HQ in Piscataway, NJ.

    Responsibilities

    SUMMARY:

    The Director/Sr. Director of Attribute Sciences will be responsible for the development, qualification, verification and technical transfer of analytical methodologies routinely used during biologics development.  He/ she will be the technical expert in physico-chemical properties of proteins and responsible for planning, designing, and executing through multiple stages of development.  In addition, he/ she will actively train and mentor a team of scientists with varying levels of experience.  This is a full-time, exempt position based in the Piscataway, NJ office. Travel to the Chicago, IL office may be required. 

     

    Essential Duties and Responsibilities:

    • Lead efforts related to method development, qualification and validation, including preparation and review of protocols, SOPs and reports.
    • Lead a team of scientists to support all analytical issues concerning biosimilar development by coordinating sample analysis for similarity assessment, formulation and process development, CQA assessment, stability studies, and forced degradation studies.
    • 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
    • As a member of multidisciplinary project team, this individual will work closely with internal and external collaborators, CRO’s, in academia and industry.
    • Train and mentor junior scientists
    • Maintain accurate data records and documentation

    Qualifications

    PREREQUISITES:

    Education & Experience:

    • Ph.D. in Biochemistry, Pharmaceutical Sciences, Chemistry or equivalent with 10+ years of biopharmaceutical industry experience in antibody/protein characterization.

     

    SPECIALIZED KNOWLEDGE AND SKILLS:

     

    Required:

    • Practical knowledge of majority of current analytical methodologies for biologics development is required such as:
      • Primary Structure and Modifications: Mass Spectrometry
      • Separations: HPLC, Capillary Electrophoresis, BLI
      • Higher Order Structure: DSC, CD, FT-IR, NMR, AUC, DLS/ MALS, MFI, HIAC
    • 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 (e.g. IND, CTA, MAA, BLA) and responding to health authority inquiries.
    • 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.

     

    Preferred:

    • Experience with pre-formulation and formulation studies of biologics
    • Familiarity with mammalian cell line development
    • Compendial requirements for stability studies and specifications for biologics

     

     

     WORK ENVIRONMENT AND PHYSICAL DEMANDS:

    General Work Environment:

    • General office setting.
    • Must be able to work extended hours or weekend hours, as may be necessary.

     

    Noise:

    • No extraordinary noise levels

     

    Standing/Lifting:

    • No extraordinary requirements.

     

    Visual:

    • No extraordinary requirements

     

    Stress:

    • High paced demanding environment to meet ambitious project goals.

     

    Travel:

    • Some travel required, but not to exceed 30%

     

    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, and 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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