• Bioprocess Development Downstream Lead

    Location US-NJ-Piscataway
    Posted Date 4 weeks ago(10/22/2018 11:28 AM)
    ID
    2018-2215
    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 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 Bioprocess Development Downstream Lead to be based out of our offices in Piscataway, NJ.

    Responsibilities

    We have an opening for a senior leader in R&D responsible for managing a team of scientists and engineers that develop downstream processes (for drug substance and drug product) for a wide range of biosimilars.  The BPD (Bioprocess Development) team is responsible for process development, process characterization, small-scale process validation, and supporting tech transfer to GMP commercial facilities in Chicago, IL, USA (up to 250-L scale),  Cashel, IRL (up to 2,000-L scale), and CMOs (Contract Manufacturing Organizations).  In addition, BPD supports and improves on-going commercial campaigns in partnership with MS&T (Manufacturing Sciences & Technology in R&D), manufacturing, and quality teams.  Title level will be determined on the basis of skills and experience.

     

    • Responsible for leading development and characterization of downstream purification bioprocesses for production of therapeutic proteins, spanning mammalian monoclonal antibody production and microbial protein production
      • Providing functional leadership to establish clinical phase-appropriate production processes
      • Facilitating process transfer, scale-up, validation and product / process comparability activities
      • Proactively identifying issues, providing general guidance to resolve CMC project issues, and develop solutions to meet productivity and quality milestones, and objectives
      • Designing and implementing rigorous product-development strategies utilizing DoE (Design of Experiment) and other process-design elements aligned with a QbD (Quality by Design) approach
      • With MS&T, optimizing current processes including reducing COGs (Cost of Goods) and improvement of product quality
      • Delivering development reports and sections of regulatory submissions including comparability, similarity, and QbD risk assessments
    • Responsible for managing a team of scientists and engineers
    • Achieving budget and timeline targets
    • Developing productive relationships with internal and external collaborators / partners
    • Responsible for multiple projects via cross-functional (matrix) management

    Qualifications

    • Candidate must have a Ph.D. with 12 (or more) years of experience in the biopharmaceutical industry or equivalent with significant emphases on purification-bioprocess development and technology transfer required
    • Recent experience with monoclonal antibodies required
    • Demonstrated ability to function effectively across a matrix organization required
    • Outstanding organizational and communication skills (especially technical writing, verbal and presentation), and excellent supervisory skills required
    • Knowledge of current GMPs, and FDA and / or European validation practices for biopharmaceutical processes required
    • Demonstrated experience with process improvements, knowledge of manufacturing, and understanding of site operations, R&D, and production systems required
    • Demonstrated success with regulatory filings including BLA submissions and product launch preferred

     

    This position will be based in Piscataway, NJ and will require occasional travel to support the global product pipeline.

     

    Education:

    Ph.D. with 12 (or more) years of experience in the biopharmaceutical industry is required

     

    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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