MacroGenics, Inc. · 2 months ago
Principal Scientist (Residual Impurities)
Rockville, MD
Full-time
Onsite
Senior Level, Lead/Staff
$130K/yr - $198K/yr
6+ years expMacroGenics is a leader in the discovery and development of innovative medicines that utilize next generation antibody-based technologies. The Principal Scientist will lead method development and lifecycle management of residual impurity assays for biopharmaceutical products, while mentoring team members and collaborating with cross-functional teams to support product development and regulatory submissions.
BiotechnologyHealth CareManufacturing
Responsibilities
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
Qualification
Required
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
Master's degree with 12+ years of related industry experience
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
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
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
Benefits
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
Disability benefits
Company
MacroGenics, Inc.
MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies.
201-500 employees
H1B Sponsorship
MacroGenics, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2023 (4)
2022 (1)
2021 (1)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$275.92MKey Investors
National Institutes of HealthNextech VentureVentures West
2019-02-12Post Ipo Equity· $110M
2013-10-10IPO
2011-01-31Private Equity· $12.02M
Leadership Team
Eric Risser
Chief Executive Officer
Leroy Hood
Co-Founder
Recent News
2025-12-11
2025-11-26
MacroGenics, Inc.
2025-11-13
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