Talent.com
Principal Scientist (Residual Impurities)

Principal Scientist (Residual Impurities)

MacroGenics, Inc.Rockville, MD, United States
7 days ago
Job type
  • Full-time
Job description

Principal Scientist (Residual Impurities)

Job Category : Development

Requisition Number : PRINC001888

Apply now

  • Posted : November 5, 2025
  • Full-Time
  • On-site

Locations

Showing 1 location

Headquarters

9704 Medical Center Dr

Rockville, MD 20850, USA

MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of350+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer. Our products and platforms have attracted multiple partnerships with leading pharmaceuticaland biotechnologycompanies 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 Principal Scientist is a technical and strategic leader responsible for method development, qualification, transfer, and lifecycle management of residual impurity assays for biopharmaceutical products including monoclonal antibodies (mAbs), bispecifics, and antibody-drug conjugates (ADCs). This individual thrives in a cross-functional, fast-paced, and collaborative environment, applying strong troubleshooting ability, scientific rigor, and a results-driven mindset to support programs from early development through commercialization. The role demands high accountability, proactive planning, and timely execution of deliverables. The Principal Scientist will supervise and mentor team members while serving as a subject matter expert in residual impurity testing across Biopharmaceutical Development (BPD) and CMC teams.

Responsibilities and Job Duties :

  • Lead the development of fit-for-purpose and robust residual impurity assays (e.g., HCP, DNA, Protein, Enzyme, Surfactant etc.) to support biologic product development and release.
  • Provide technical leadership and hands‑on troubleshooting for analytical methods and instrumentation to resolve issues efficiently and maintain method robustness.
  • Own and drive method lifecycle activities including development, qualification, transfer to QC, and support method validation aligned with ICH and regulatory expectations.
  • Ensure on‑time delivery of analytical method development and testing support for process development, process characterization, analytical comparability, and CQA assessment efforts.
  • Manage project timelines for impurity analysis and proactively communicate risks, progress, and mitigation strategies to stakeholders.
  • Collaborate with CMC teams and Regulatory Affairs to develop residual impurity control strategies, specifications, and regulatory submissions.
  • Manage vendor activities and oversee outsourced work including critical reagents, HCP coverage analysis, and CRO support.
  • Lead implementation of new technologies and data‑driven approaches to improve throughput and sensitivity of impurity assays.
  • Author and / or review SOPs, technical protocols and reports, and regulatory filings.
  • Foster a high‑performance culture by coaching and mentoring scientists, promoting scientific excellence, accountability, and ownership.
  • Present findings and strategies at internal cross‑functional meetings, technical forums, and external conferences.
  • Participate in industry consortia on relevant topics and align internal strategies with industry practice.
  • Qualifications

    Education & Experience

  • Ph.D. in Biochemistry, Analytical Chemistry, Chemical Engineering, Pharmaceutical Sciences or related discipline with 6+ years of related industry experience, including 5+ years on residual impurity method development;
  • or

  • Master’s degree with 12+ years of related industry experience;
  • or

  • Bachelor’s degree with 14+ years of related industry experience
  • 2+ years of people management experience with demonstrated ability to coach, develop and motivate high‑performing teams
  • Prior experience in preparing analytical sections of IND, BLA and regulatory responses.
  • Knowledge, Skills and Abilities

  • Deep knowledge of residual impurity assay development (e.g. ELISA for residual protein, qPCR for DNA)
  • Excellent troubleshooting and problem‑solving skills, with a systematic, data‑driven approach to resolving technical challenges
  • Strong sense of accountability and ownership; consistently delivers to project goals and regulatory milestones
  • Ability to manage multiple projects and priorities in a dynamic, cross‑functional environment
  • Skilled in stakeholder management, with clear, proactive, and collaborative communication style
  • Strong technical writing skills and attention to detail in documentation and data review
  • Experience mentoring and developing scientific staff; promotes open communication and teamwork
  • Solid understanding of CMC strategy, regulatory expectations, and phase appropriate analytical requirements
  • Strong track record of independent troubleshooting, root cause investigation, and method remediation for impurity assays
  • Proven success in delivering high‑quality results on time, even under changing priorities and compressed timelines.
  • Demonstrated leadership and influence in cross‑functional matrix environments
  • Preferred Qualifications

  • Familiarity with potency assays, physiochemical assays and other characterization assays
  • Knowledge in novel techniques on detecting and analyzing residual impurities
  • Strong publication record and external scientific presence
  • Experience in fostering partnership with clients through CDMO service
  • Supervisory Responsibilities

    Yes. This role may supervise Associate Scientist and / or Scientist

    Additional Information

    The annual rate of pay for this position ranges from $129,500 - $197,500. For non‑exempt roles, and according to applicable regulations, there may be the possibility for overtime pay. This role is eligible for the Company’s discretionary bonus and discretionary equity incentives. Eligible employees may participate in the Company’s benefits programs, including medical / dental / vision / prescription coverage, employee wellness resources, 401(k) plan with employer match, access to an Employee Stock Purchase Plan, (ESPP), paid time off & paid parental leave benefits, and disability benefits.

    The annual pay rate range is described in good faith, and the Company believes is the range of possible compensation for this role at the time of this posting depending on the candidate’s experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range, and this range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

    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

    Equal Opportunity Employer. This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

    We do not accept non‑solicited resumes or candidate submittals from search / recruiting agencies.

    #J-18808-Ljbffr

    Create a job alert for this search

    Principal Scientist • Rockville, MD, United States

    Related jobs
    • Promoted
    Principal / Sr. Principal Systems Administrator

    Principal / Sr. Principal Systems Administrator

    Northrop GrummanPatuxent, MD, US
    Full-time
    RELOCATION ASSISTANCE : No relocation assistance available.At Northrop Grumman, our employees have incredible opportunities to work on revolutionary systems that impact people's lives around the wo...Show moreLast updated: 15 days ago
    • Promoted
    Scientist I

    Scientist I

    Novavax, Inc.Gaithersburg, MD, United States
    Full-time
    Who We Are : A Mission Driven Company.Novavax has a rich history of innovation to help eradicate disease, prevent serious. But there is still work to be done.This role will play an important role in ...Show moreLast updated: 30+ days ago
    • Promoted
    Principal Scientist (Residual Impurities)

    Principal Scientist (Residual Impurities)

    MacroGenics, Inc.Rockville, MD, United States
    Full-time
    Principal Scientist (Residual Impurities).MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies.Our team of35...Show moreLast updated: 4 days ago
    • Promoted
    Immunogenicity - Principal Scientist

    Immunogenicity - Principal Scientist

    AmgenWashington, DC, United States
    Full-time
    Join Amgen’s Mission of Serving Patients.At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives a...Show moreLast updated: 18 days ago
    • Promoted
    Education and Science Principal

    Education and Science Principal

    HDRWashington, DC, US
    Full-time
    Education And Science Principal.At HDR, our employee-owners are fully engaged in creating a welcoming environment where each of us is valued and respected, a place where everyone is empowered to br...Show moreLast updated: 30+ days ago
    Research Scientist III (Infectious Disease Epidemiology and Health Services Research)

    Research Scientist III (Infectious Disease Epidemiology and Health Services Research)

    Mid-Atlantic Permanente Medical GroupUSA, District of Columbia, Washington
    Full-time
    Mid-Atlantic Permanente Medical Group (MAPMG) invites applications for the position of.Infectious Disease Epidemiology / Health Services Research),. Mid-Atlantic Permanente Research Institute (MAPRI)....Show moreLast updated: 30+ days ago
    • Promoted
    Research Associate, Microbiology (#1876)

    Research Associate, Microbiology (#1876)

    BNBIFort Detrick, MD, United States
    Temporary
    The National Biodefense Analysis and Countermeasures Center (NBACC) is a one-of-a-kind facility located on Fort Detrick in Frederick MD and is dedicated to defending the nation against biological t...Show moreLast updated: 30+ days ago
    • Promoted
    Adjunct, Microbiology

    Adjunct, Microbiology

    InsideHigherEdFrederick, Maryland, United States
    Full-time
    Facilitate student mastery of core learning outcomes using the most relevant and scholarly and artistic tools and practices available in the discipline. Actively engage students in critical thinking...Show moreLast updated: 30+ days ago
    • Promoted
    Cardiovascular Invasive Specialist 2 (Interventional Radiology (IR Tech))

    Cardiovascular Invasive Specialist 2 (Interventional Radiology (IR Tech))

    Inova Health SystemAlexandria, VA, United States
    Full-time
    Inova Alexandria Hospital is looking for a dedicated Electrophysiology Invasive Specialist (EP Lab) to join the team.This role will be Day shift, M-F, (4) 10 hr shifts. Sign-on bonus and relocation ...Show moreLast updated: 9 days ago
    • Promoted
    Immunogenicity - Principal Scientist

    Immunogenicity - Principal Scientist

    BioSpaceWashington, DC, United States
    Full-time
    Immunogenicity - Principal Scientist.At Amgen, we are driven by a mission to serve patients living with serious illnesses. Since 1980, we have pioneered biotech solutions across Oncology, Inflammati...Show moreLast updated: 30+ days ago
    • Promoted
    Director of Toxicology

    Director of Toxicology

    InotivGaithersburg, MD, United States
    Full-time
    The Director of Toxicology is the scientific leader for the site and serves as a mentor and manager for a group of Study Directors overseeing general toxicology and safety pharmacology studies.As a...Show moreLast updated: 28 days ago
    • Promoted
    Research Scientist

    Research Scientist

    InsideHigherEdBaltimore, Maryland, United States
    Full-time
    School of Medicine - Clinical Departments.Show moreLast updated: 30+ days ago
    Research Scientist II (Infectious Disease Epidemiology Health Services Research)

    Research Scientist II (Infectious Disease Epidemiology Health Services Research)

    Mid-Atlantic Permanente Medical GroupUSA, District of Columbia, Washington
    Full-time
    Mid-Atlantic Permanente Medical Group (MAPMG) invites applications for the position of.Infectious Disease Epidemiology / Health Services Research),. Mid-Atlantic Permanente Research Institute (MAPRI)....Show moreLast updated: 30+ days ago
    • Promoted
    Inaugural Executive Director, Institute for Advanced Computing

    Inaugural Executive Director, Institute for Advanced Computing

    InsideHigherEdAlexandria, Virginia, United States
    Full-time
    Inaugural Executive Director, Institute for Advanced Computing.Virginia Tech – Greater Washington, D.Virginia Tech invites nominations and applications for the position of the inaugural Executive D...Show moreLast updated: 30+ days ago
    • Promoted
    • New!
    Research Scientist

    Research Scientist

    SMOOREManassas, VA, US
    Full-time
    We are seeking a highly motivated and collaborative Research Scientist with skills and experience in natural products chemistry to join our dynamic research team. The ideal candidate will have resea...Show moreLast updated: 20 hours ago
    • Promoted
    • New!
    Principal Research Scientist

    Principal Research Scientist

    Alarm.comMcLean, VA, United States
    Full-time
    ObjectVideo Labs, a subsidiary of Alarm.Research Scientist to join our expanding R&D team and focus on solving real-world problems. The successful candidate will play a pivotal role in driving resea...Show moreLast updated: 6 hours ago
    • Promoted
    Physician-Scientist, Director Of Clinical Trial Innovation (tenure-track)

    Physician-Scientist, Director Of Clinical Trial Innovation (tenure-track)

    InsideHigherEdBaltimore, Maryland, United States
    Full-time
    School of Medicine - Centers / Programs / ORCs.Show moreLast updated: 30+ days ago
    • Promoted
    Principal / Senior Principal Modeling Simulation Analysis Systems Engineer

    Principal / Senior Principal Modeling Simulation Analysis Systems Engineer

    Northrop GrummanBaltimore, MD, US
    Full-time
    RELOCATION ASSISTANCE : Relocation assistance may be available.At Northrop Grumman, our employees have incredible opportunities to work on revolutionary systems that impact people's lives around th...Show moreLast updated: 2 days ago