• Scientist II/III – Cell Culture Sciences (Process Development)

    Category Development
    ID
    2018-1240
    Job Location
    US-MD-Rockville
    Type
    Regular Full-Time
  • Overview

    MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies.  Our team of 300+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer as well as various autoimmune disorders and infectious diseases.  Our products and platforms have attracted multiple partnerships with leading pharmaceutical companies around the globe.

     

    The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.

    Summary of Position

    The Scientist II/III is a key team member focused on early and late stage process development and optimization, as well as late stage process characterization and validation of cell culture processes.  This individual will be responsible for managing and leading cell culture projects and for solving scientific problems related to robust process development and characterization. This individual will have a crucial role in the design, execution, and analysis of experiments and will provide interpretations and conclusions in technical reports and regulatory filings.

     

    Responsibilities and Job Duties

    • Drive and execute activities related to early stage pipeline programs, including process development, scale-up, toxicology material production, raw materials strategies, technology transfer, clinical material manufacturing support, platform development and regulatory submissions, to support development of processes leading to clinical launch, commercialization and improved commercial manufacturing.
    • Author and review sections of regulatory filings, protocols and technical reports in collaboration with the development, manufacturing, quality, and regulatory groups.
    • Lead and execute late-stage program commercialization projects, including the design, planning, and execution of process characterization and validation studies.
    • Support the technology transfer of cell culture processes for GMP manufacturing. Develop continuous improvement projects, implement manufacturing campaign monitoring methods and provide regulatory support through the product life-cycle.
    • Present scientific findings at internal and external meetings and author scientific journal publications. Integrate new technologies for process development and commercial production.
    • Analyze, interpret and present data at group and project meetings, and other scientific forums. Collaborate with internal and external partners to ensure project timelines are met.
    • Take an active role in maintaining the laboratory equipment and ensuring a safe working environment.
    • Maintain awareness of current scientific trends and technical aspects from conferences, local meetings, and the literature.

    Qualifications

    Education & Experience

    Scientist II

    • PhD in Biochemistry, Chemistry, Chemical Engineering, Pharmaceutical Sciences or life sciences and a minimum of 2 years of related experience with at least 1 years’ experience in early to late stage CMC process development for clinical or commercial biopharmaceuticals including document authoring; or
    • Masters’ degree in Biochemistry, Chemistry, Chemical Engineering, Pharmaceutical Sciences or life sciences and a minimum of 11 years of related experience with at least 6 years’ industry experience in early to late stage CMC process development of biological molecules including document authoring; or
    • Bachelors’ degree in Biochemistry, Chemistry, Chemical Engineering, Pharmaceutical Sciences or life sciences and a minimum of 14 years of related experience, at least 10 of which in the biotech or biopharmaceutical industry in a similar role
    • Hands-on experience with bench to intermediate scale-single use bioreactors, developing high-titer cell culture processes; media development and process scale-up experience
    • Late stage CMC experience, including process characterization, validation and commercialization including document authoring

    Scientist III

    • PhD in Biochemistry, Chemistry, Chemical Engineering, Pharmaceutical Sciences or life sciences and a minimum of 5 years of related experience with at least 2 years’ experience in early to late stage CMC process development for clinical or commercial biopharmaceuticals including document authoring; or
    • Masters’ degree in Biochemistry, Chemistry, Chemical Engineering, Pharmaceutical Sciences or life sciences and a minimum of 14 years of related experience with at least 6 years’ industry experience in early to late stage CMC process development for clinical or commercial biopharmaceuticals including document authoring; or
    • Bachelors’ degree in Biochemistry, Chemistry, Chemical Engineering, Pharmaceutical Sciences or life sciences and a minimum of 17 years of related experience, at least 10 of which in the biotech or biopharmaceutical industry in a similar role
    • Hands-on experience with bench to intermediate scale-single use bioreactors, developing high-titer cell culture processes; media development and process scale-up experience
    • Late stage CMC cell culture experience, including process characterization, validation and commercialization for clinical or commercial biopharmaceuticals including document authoring

     

    Knowledge, Skills and Abilities

    • Proven ability to solve technical and scientific problems in a collaborative environment
    • Strong verbal, presentation and writing skills to communicate effectively internally and externally
    • Solid understanding of current FDA and ICH guidelines regarding cell culture drug substance processes to meet regulatory expectations
    • Proven track record of authoring, planning, executing and reviewing development and validation protocols and reports
    • Specific knowledge and in-depth understanding of cell culture and scale up processes
    • Experience with early and late stage cell culture process development activities and process characterization for cell culture unit operations
    • Strong understanding of statistical tools and knowledge of DOE and QbD principles. Ability to critically analyze data using statistical tools for process performance to compile technical reports and other documentation
    • Ability to collaborate with and influence other functional areas such as Validation and Regulatory Affairs
    • Ability to lead, train and mentor staff
    • Strong organizational skills and ability to prioritize multiple projects to completion
    • Ability to lead cross-functional teams, be collaborative, and represent teams at a variety of forums
    • Ability to set-up, maintain, and troubleshoot equipment and drive implementation of new technologies for process development and commercial production
    • Willingness to work occasional weekends as needed

     

    Supervisory Responsibilities

    May supervise one or more Bioprocess Associates

    Statement

    MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email info@macrogenics.com or call (301) 354-3566 and/or 711 for TTD/TTY service.

    Equal Opportunity Employer/Veterans/Disabled

     

    For more information about our commitment to equal employment opportunity, please click here.

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