Lead QC & Analytical Development Scientist

LifeSprout; Baltimore (MD); On-site; USD 130,000 - 190,000; Full time

Benefits offered by this job

Competitive compensation

Professional development opportunities

Onsite presence

Job summary

LifeSprout in Baltimore, MD, seeks a Senior / Principal Scientist in QC and Analytical Development to lead analytical method development, qualification, validation, and QC lab operations for biomaterials and finished devices.

This hands-on role requires coordinating with R&D, manufacturing, regulatory, and quality to ensure GMP/ISO 13485 compliant testing, data integrity, and method lifecycle management, shaping the analytical strategy across projects.

Qualifications

• Hands‑on experience developing and troubleshooting analytical methods for biomaterials and medical devices.
• Experience with GMP/ISO 13485 environments and leading validation efforts.
• Strong technical writing and documentation skills for protocols, reports, and regulatory submissions.
• Ability to lead multiple workstreams in a fast-paced, regulated setting.

Responsibilities

• Design, develop, and validate analytical, chemical, physical, and mechanical test methods for biomaterials and devices.
• Draft and review SOPs, QC work instructions, sampling plans, and validation documentation.
• Oversee QC lab operations, scheduling, equipment, and data integrity.
• Collaborate with R&D, manufacturing, regulatory, quality, and supply chain to align testing strategy with product development.
• Lead method transfer and lifecycle management across development and production.
• Support supplier qualification and regulatory submissions with validated data.

Skills

Analytical method development

GMP/ISO 13485 awareness

Statistical sampling & validation

Technical writing

Cross-functional collaboration

Education

MS in Analytical Chemistry / Materials Science / Biomedical Engineering or related

PhD desirable for Principal level

Tools

Spectrophotometer

Rheometer

Particle size analyzer

Job description

LifeSprout in Baltimore, MD, seeks a Senior / Principal Scientist in QC and Analytical Development to lead analytical method development, qualification, validation, and QC lab operations for biomaterials and finished devices.

This hands-on role requires coordinating with R&D, manufacturing, regulatory, and quality to ensure GMP/ISO 13485 compliant testing, data integrity, and method lifecycle management, shaping the analytical strategy across projects.