• Scientist III, Analytical Sciences (Process Analytics)

    Category Development
    ID
    2019-1259
    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 III is responsible for supporting analytical activities for biologics programs at different stages of development within the BioProcess Development (BPD) department.  The role will involve supporting high throughput in-process analytical testing, delivering results within project timelines, assay harmonization with analytical method development group, and evaluation, as well as implementation of new analytical technologies for supporting developability assessment. This individual will work closely with analytical method development and characterization teams in a results-driven, collaborative environment. This individual will also be responsible for supervising and mentoring direct report(s) to support these activities. 

     

    Responsibilities and Job Duties

    • Lead in-process analytical testing for antibody-based molecules, including HPLC/UPLC, capillary electrophoresis, lab-on-chip methods, and biophysical techniques.  Identify the appropriate experimental methodology for analytical testing, conduct the analysis and provide interpretations and conclusions from the results in a report for each project in a timely manner.
    • Support developability efforts for early stage pipeline molecules by working with the process development teams and developing higher throughput methods for assessing product quality.
    • Develop high throughput and automated assays for increasing assay efficiency and reducing assay variation.
    • Develop novel strategies and evaluate new analytical technologies for improving throughput, analytical capability and assay performance for implementation towards pipeline programs.
    • Perform physicochemical and biophysical analyses working in collaboration with analytical method development and characterization group to characterize biologics molecules.
    • Analyze, interpret and present data at group and project meetings, and other scientific forums to communicate results from the different lab-based studies.
    • Support activities related assay harmonization and platform method development within the analytical group by working with method development group.
    • Lead cross-functional Chemistry, Manufacturing and Control (CMC) teams for developing pipeline programs and represent at the project team forums, helping to ensure project timelines are met.
    • Author technical reports summarizing the process analytics results and other technical documentation required to support regulatory filings.
    • Actively oversee the operation and maintenance of analytical equipment and instruments, resolve operational issues in a timely manner to avoid negative impact on studies, and implement best practices to ensure peak performance. Train analysts on analytical methods and techniques.
    • Ensure that all work is performed in a compliant manner to meet safety procedures and applicable regulatory guidelines and work to continuously improve safety and lab procedures through strong oversight and management of team.
    • Recruit, select and provide leadership to team members who support these activities through driving accountability, effective people development including coaching and mentoring to maximize employee engagement, productivity and effectiveness.
    • Serve as an analytical resource for the department and project teams, proactively keeping colleagues updated with current scientific trends and technical aspects from conferences, local meetings, and the literature.
    • Establish strong working relationships with other groups, including analytical method development, characterization, quality, drug product, cell culture and purification sciences, to ensure smooth communication and collaboration across departments. 

    Qualifications

    Education & Experience

    • PhD in Biochemistry, Chemistry, Chemical Engineering, Pharmaceutical Sciences, or Life Sciences and 5 years of related industry experience, including 3 years of experience analyzing biological molecules; or
    • Master’s degree in Biochemistry, Chemistry, Chemical Engineering, Pharmaceutical Sciences, or Life Sciences and 14 years of related industry experience, including 8 years of experience analyzing biological molecules; or
    • Bachelor’s degree in Biochemistry, Chemistry, Chemical Engineering, Pharmaceutical Sciences, or Life Sciences and 17 years of related industry experience, including 12 years of experience analyzing biological molecules
    • Extensive hands on experience with higher throughput techniques for protein/peptide separations including liquid chromatography (LC), Capillary Electrophoresis (CE) and biophysical techniques
    • Prior experience coaching, mentoring, and/or giving feedback to others

    Knowledge, Skills and Abilities

    • Knowledge of high throughput techniques for analysis of antibody-based molecules
    • Strong protein characterization skills
    • Excellent record keeping abilities to adequately record, analyze, and document analytical data generated in support of regulatory requirements
    • Ability to compile and review technical reports and other documentation
    • Strong communication, presentation, and writing skills
    • Demonstrated skills working collaboratively and cross functionally
    • Ability to recruit and select, manage, train, and mentor staff

    Preferred Skills

    • Previous experience supervising others strongly preferred
    • Experience with developing analytical platform to support early stage developability studies
    • Experience in building or supporting developability platform tools
    • Good understanding of statistical tools and knowledge of CQA, DoE and QbD principles
    • Experience in preparing analytical sections of regulatory documents such as IND, BLA and regulatory discussion documents
    • Appreciation of upstream and downstream process development activities
    • Experience with both early and late stage development is preferred
    • Experience in orthogonal characterization techniques for protein mass, size, structure and charge
    • Strong understanding of CMC functions

    Supervisory Responsibilities

    Development Associate(s)

    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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