Principal Scientist (Physicochemical Assay)

MacroGenics, Inc.•Rockville, MD

About The Position

The Principal Scientist is a technical and strategic leader responsible for development, qualification, transfer, and lifecycle management of physicochemical assays (e.g. chromatography, electrophoresis), as well as managing sample testing with physicochemical assays, for biopharmaceutical products (monoclonal antibodies, bispecifics, and antibody-drug conjugates). This position is 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 physicochemical assay development and testing.

Requirements

PhD. in Biochemistry, Analytical Chemistry, Chemical Engineering, Pharmaceutical Sciences or related discipline with 6+ years of related industry experience, including 6+ years on physicochemical method development; or Master’s degree with 12+ years of related industry experience; or Bachelor’s degree with 14+ years of related industry experience
4+ years hands-on experience in physicochemical method development.
3+ 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.
Experience in troubleshooting and root cause analysis on physicochemical assay performance and instruments, with a systematic, data-driven approach to resolving technical challenges
Familiarity with instruments and items used on physicochemical assays
Strong technical writing skills and attention to detail in documentation and data review
Experience in mentoring and developing scientific staff, promoting open communication and teamwork
Experience in logistic planning and using project management tools (MS Project, SmartSheet).
Solid understanding of CMC strategy, regulatory expectations, and phase appropriate analytical requirements
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

Nice To Haves

Knowledge in potency assays, residual impurity assays, and product characterization assays.
Knowledge in automation and high-throughput instruments.
Knowledge in Multi-Attribute Methods (MAMs).
Strong publication record and external scientific presence.
Experience in fostering partnership with clients of CDMO services.

Responsibilities

Lead a team of scientists to develop phase-appropriate, fit-for-purpose and robust physicochemical assays (e.g., SEC, IEC, CE, cIEF, PS80, DAR, etc.) to support biologic product development and release.
Oversee physicochemical method development and transfer to the Quality Control (QC) team. Support method qualification and method validation at QC.
Manage day-to-day activities of the Physicochemical team, ensuring timely delivery of high-quality results.
Provide technical leadership and hands-on troubleshooting support on analytical methods and instruments.
Manage project timelines for physicochemical method development and sample testing, and proactively communicate risks, progress, and mitigation strategies to stakeholders.
Optimize resource allocation to align the Physicochemical team’s operations with the company’s goals and timelines.
Author and review SOPs, technical protocols and reports, and regulatory filings.
Oversee preventive maintenance service contracts of instruments to ensure optimal instrument performance.
Foster strong cross-functional communication and collaboration with other functions.
Drive adaptation of new technologies and data-driven approaches to enhance efficiency and throughput.
Foster a high-performance culture by coaching and mentoring scientists, promoting scientific excellence, accountability, and ownership.
Present findings and strategies at internal meetings, technical forums, and external conferences. Participate in industry consortia and align internal strategies with industry practice.