• Manufacturing Engineer, New Product Introduction

    Lotte Biologics USA LLC (Syracuse, NY)


    We are LOTTE BIOLOGICS ! Delivering Therapies That Enable a Healthier World.

     

    A new company, built on 80 years of tradition. We embody our core values of being Inspired by Science, Embracing Diversity, Fostering Talent, and Connecting Lives. Our mission is to be the most trusted partner in the industry, with high standards of quality and continuous innovation, to reliably deliver benefits for patients worldwide.

    Position Summary

    The Manufacturing Engineer will act as a technology transfer lead in the Technical Manufacturing group. This position is accountable for the technical work between the sending and receiving sites to ensure design and transfer of robust manufacturing processes for new products and key lifecycle biologic products. This position ensures processes are designed and validated per applicable cGMPs, LOTTE BIOLOGICS procedures, and that processes are defined consistent with regulatory filings. This position will also be responsible for reviewing key CMC submissions, along with setting relevant standards and creating /maintaining associated tech transfer business processes. This position works in a team-driven environment on customer projects to enable transfer to GMP manufacturing. This position is an individual contributor position.

     

    Duties & Responsibilities

     

    + Leads technology transfer projects for key lifecycle biologic products, including the establishment of the process/parameters for each unit operation of the process, and up until the completion of process performance qualification and subsequent CMC filing activities, if required by quality agreement. May include development, characterization, optimization and troubleshooting product and manufacturing processes of sending unit.

    + Designs, prepares, and reviews technology transfer protocols, methods/processes, experimental or authoring plans or templates as appropriate. Responsible to create, maintain and harmonize key tech transfer business processes.

    + Partners with the site management team in the identification of best practices in industry related to technology transfers, pharmaceutical technology to create a competitive advantage. Partners with site operations to provide a manufacturing process that is sustainable for future product supply. Partners with existing sites in the network to incorporate lessons learned from ‘sending’ sites for an optimized manufacturing process.

    + Develops and maintains effective working relationships with other division groups in support of technology transfer, validation, and process support activities.

     

    Education & Experience

     

    + BS or MS degree in Biotechnology, Bio-Chemical Engineering, Biochemistry or related Life Science subject. Chemical Engineering degree preferred.

    + 5+ years of experience as an engineer in biologics operation with a firm understanding of how complex biologics/pharmaceutical production processes run.

     

    Knowledge, Skills, Abilities

     

    + Demonstrated experience with the support and execution of technology transfer and scale up programs for development and/or commercial drug substance manufacturing processes is required.

    + Subject matter expert in biologics/pharmaceutical process operations: aseptic processing, sterilization, sterile filtration, centrifuge/depth filtration, cell passaging, chromatography, UF/DF. Strong knowledge of global regulatory requirements related to the design and control of these processes.

     

    Physical Demands

     

    Physical exertion may be required including sitting, standing, repetitive (use of arm, hands, wrists), and walking while working for sustained periods. Role will require appropriate personal protective equipment (PPE) in classified areas.

     

    Work Environment

     

    Office space, manufacturing space, lab space, inside work, working alone, working with/around others.

     

    Travel

     

    This position may require up to 5% travel.

     

    Target Bonus

     

    10%

    Work Location:

    East Syracuse, NY

     

    New York Pay Range

     

    $76,000 — $113,000 USD

     

    We are an Equal Employment Opportunity (“EEO”) Employer.

     

    We believe that women, people of color, veterans and LGBTQ communities must participate in the work we do, so we strongly encourage applications from people with these identities or who are members of underrepresented communities!  If this is the work that you want to do, in a culture of inclusion and excellence with the goal of making our world to be a healthier place, then please apply today!