Principal Scientist; Residual Impurities

Principal Scientist (Residual Impurities)

Job Category:
Development

Requisition Number: PRINC
001888

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• Posted :
November 5, 2025

• Full-Time

• On-site

Locations

Showing 1 location

Headquarters
9704 Medical Center Dr
Rockville, MD 20850, USA

Macro Genics 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. Macro Genics' 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…