MacroGenics, Inc.
Overview MacroGenics is a leader in the discovery and development of innovative medicines using next generation antibody-based technologies. The company emphasizes innovation, open communication, and teamwork to advance a pipeline of product candidates to treat patients with cancer.
If the following job requirements and experience match your skills, please ensure you apply promptly. 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). The role requires strong troubleshooting, scientific rigor, and a results-driven mindset to support programs from early development through commercialization. The Principal Scientist will supervise and mentor team members and serve as a subject matter expert in residual impurity testing across Biopharmaceutical Development (BPD) and CMC teams. Responsibilities
Lead the development of fit-for-purpose and robust residual impurity assays (e.g., HCP, DNA, protein, enzyme, surfactant) to support biologic product development and release. Provide technical leadership and hands-on troubleshooting for analytical methods and instrumentation to resolve issues 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
Ph.D. in Biochemistry, Analytical Chemistry, Chemical Engineering, Pharmaceutical Sciences or related field 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; plus 2+ years of people management experience and experience 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 data-driven approach. Strong accountability, ownership, and ability to deliver to project goals and regulatory milestones. Ability to manage multiple projects in a dynamic, cross-functional environment. Effective stakeholder management with clear, proactive communication. Strong technical writing skills and attention to detail in documentation and data review. Experience mentoring scientific staff and promoting open communication and teamwork. Solid understanding of CMC strategy, regulatory expectations, and phase-appropriate analytical requirements. Track record of independent troubleshooting, root cause investigation, and method remediation for impurity assays. Proven ability to deliver high-quality results on time under changing priorities. Preferred Qualifications
Familiarity with potency assays, physiochemical assays, and other characterization assays. Knowledge of novel techniques for detecting and analyzing residual impurities. Strong publication record and external scientific presence. Experience partnering with clients through CDMO services. 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, overtime pay may be applicable where allowed by regulations. This role is eligible for discretionary bonus and discretionary equity incentives. Benefits include medical/dental/vision/prescription coverage, wellness resources, 401(k) with employer match, ESPP, paid time off and parental leave, and disability benefits. The posted pay range is a good faith estimate and may be adjusted based on experience, location, and other factors. MacroGenics is proud to be an equal opportunity employer. Employment decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or other protected status. Reasonable accommodations are provided during the employment process upon request. Equal Opportunity Employer / Veterans / Disabled We do not accept non-solicited resumes or candidate submittals from search/recruiting agencies.
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If the following job requirements and experience match your skills, please ensure you apply promptly. 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). The role requires strong troubleshooting, scientific rigor, and a results-driven mindset to support programs from early development through commercialization. The Principal Scientist will supervise and mentor team members and serve as a subject matter expert in residual impurity testing across Biopharmaceutical Development (BPD) and CMC teams. Responsibilities
Lead the development of fit-for-purpose and robust residual impurity assays (e.g., HCP, DNA, protein, enzyme, surfactant) to support biologic product development and release. Provide technical leadership and hands-on troubleshooting for analytical methods and instrumentation to resolve issues 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
Ph.D. in Biochemistry, Analytical Chemistry, Chemical Engineering, Pharmaceutical Sciences or related field 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; plus 2+ years of people management experience and experience 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 data-driven approach. Strong accountability, ownership, and ability to deliver to project goals and regulatory milestones. Ability to manage multiple projects in a dynamic, cross-functional environment. Effective stakeholder management with clear, proactive communication. Strong technical writing skills and attention to detail in documentation and data review. Experience mentoring scientific staff and promoting open communication and teamwork. Solid understanding of CMC strategy, regulatory expectations, and phase-appropriate analytical requirements. Track record of independent troubleshooting, root cause investigation, and method remediation for impurity assays. Proven ability to deliver high-quality results on time under changing priorities. Preferred Qualifications
Familiarity with potency assays, physiochemical assays, and other characterization assays. Knowledge of novel techniques for detecting and analyzing residual impurities. Strong publication record and external scientific presence. Experience partnering with clients through CDMO services. 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, overtime pay may be applicable where allowed by regulations. This role is eligible for discretionary bonus and discretionary equity incentives. Benefits include medical/dental/vision/prescription coverage, wellness resources, 401(k) with employer match, ESPP, paid time off and parental leave, and disability benefits. The posted pay range is a good faith estimate and may be adjusted based on experience, location, and other factors. MacroGenics is proud to be an equal opportunity employer. Employment decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or other protected status. Reasonable accommodations are provided during the employment process upon request. Equal Opportunity Employer / Veterans / Disabled We do not accept non-solicited resumes or candidate submittals from search/recruiting agencies.
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