Principal Scientist, Biologics Analytics (Hybrid)

HiTalento TALENTO ApS; Cambridge (MA); Hybrid; USD 180,000 - 270,000; Full time

Job summary

Hemab Therapeutics in Cambridge, MA is seeking a Principal Scientist to lead analytical development for biologics as programs advance toward clinical and commercial readiness. You will shape analytical strategy, oversee GMP/QC activities, and guide CROs/CDMOs while solving complex method validation challenges.

Collaboration across Drug Substance, Drug Product, and Regulatory teams is essential. Regular cross-time-zone collaboration and on-site presence at least one day per week are expected as

Qualifications

• Extensive experience setting analytical strategy for biologics, especially antibodies.
• Proven track record leading CROs/CDMOs and managing external analytical testing.
• Experience producing analytical content for regulatory submissions (BLAs/MAAs).

Responsibilities

• Own analytical strategy for biologics programs through late-stage development and readiness for commercial use.
• Lead method transfer, optimization and validation with CROs/CDMOs and ensure protocol support.
• Guide external partners through analytical challenges and keep work moving when solutions are not straightforward.
• Establish phase-appropriate analytical approaches, including specifications, reference standards and stability protocols.
• Ensure potency assays support phase 3 readiness and work with cross-functional teams.
• Contribute to regulatory submissions and interact with authorities as needed.
• Manage data interpretation, process characterization, and risk assessments.
• Lead CRO/CMO relations, monitor regulatory trends, and seek efficiency/cost improvements.

Skills

Biologics strategy

CRO/CDMO management

Regulatory submissions

Education

PhD in a relevant field

Job description

Hemab Therapeutics in Cambridge, MA is seeking a Principal Scientist to lead analytical development for biologics as programs advance toward clinical and commercial readiness. You will shape analytical strategy, oversee GMP/QC activities, and guide CROs/CDMOs while solving complex method validation challenges.

Collaboration across Drug Substance, Drug Product, and Regulatory teams is essential. Regular cross-time-zone collaboration and on-site presence at least one day per week are expected as