Principal Scientist

Principal Scientist (Residual Impurities) If you would like to know a bit more about this opportunity, or are considering applying, then please read the following job information. 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 or call (3 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. xrczosw We do not accept non‑solicited resumes or candidate submittals from search/recruiting agencies. #J-18808-Ljbffr