Senior / Principal Scientist, QC and Analytical Development

• Design, develop, and validate analytical, chemical, physical, and mechanical test methods relevant to incoming raw materials, biomaterials and finished devices.
• Create, review, and execute method development and validation protocols, stability studies, and release testing with clear, defensible test reports.
• Draft and maintain SOPs, QC work instructions, sampling plans, and validation documentation in accordance with GMP and ISO standards.
• Define sampling strategies and test plans for incoming materials, in-process controls, subcomponents, and finished product release.
• Establish and maintain LifeSprout’s analytical assay strategy, including selection of fit-for-purpose methods, justification of assay suitability, definition of acceptance criteria, and alignment of development, qualification, validation, and transfer activities with current industry expectations.
• Oversee QC laboratory operations including scheduling, equipment requirements, lab layout, materials management and recordkeeping.
• Maintain analytical methods throughout their lifecycle, including method performance monitoring, investigation of assay variability, change control support, periodic review of method suitability, and transfer of methods into routine QC use.
• Collaborate cross-functionally with R&D, manufacturing, regulatory, quality, and supply chain to align testing strategy with product development, manufacturing, quality system, and regulatory requirements.
• Lead prioritization of QC and analytical development workstreams, balancing development studies, validation activities, release testing, equipment readiness, documentation deadlines, and cross-functional project needs.
• Support supplier qualification and regulatory submissions by providing method validation rationale and test data.
• Ensure analytical data, laboratory records, protocols, reports, and QC documentation are complete, accurate, attributable, legible, contemporaneous, original, and maintained in accordance with applicable data integrity and quality system expectations.

• Hands-on experience developing and troubleshooting analytical methods for biomaterials characterization, such as  image-based morphological measurements, particle size and geometry, spectrophotometry-based chemical analysis, and physical or mechanical techniques such as rheology.
• MS in Analytical Chemistry, Materials Science, Biomedical Engineering, Chemical Engineering, or related discipline; PhD desirable for Principal level.
• Senior level: 5+ years of hands-on experience developing and validating analytical, physical, or mechanical methods for biomaterials or medical devices. Principal level: 8+ years of relevant experience with demonstrated leadership of complex method development, validation, or analytical control strategy programs.
• Experience defining sampling plans and statistical approaches for method validation and acceptance criteria.
• Proven experience working within GMP and ISO 13485 environments, including authoring and executing validation protocols, SOPs, work instructions, deviations or investigations, and validation reports suitable for quality system records and regulatory review.
• Strong technical breadth with chemical and physical characterization techniques and mechanical testing relevant to soft materials.
• Excellent technical writing skills and experience generating protocols, test reports, and regulatory‑grade documentation.
• Self-starter with strong organizational, problem-solving, and prioritization skills; able to work independently, manage multiple technical workstreams, and lead cross-functional initiatives in a fast-paced regulated environment.

• Experience with QC lab management in regulated environments, including equipment qualification, instrument maintenance planning, lab scheduling, materials management, documentation control, and readiness for audits or inspections.
• Prior involvement supporting regulatory submissions and/or audits.
• Leadership experience mentoring scientists and technicians; stronger emphasis on people and program leadership for Principal level.

• Onsite presence required for laboratory activities with occasional travel (<10%).
• Fast paced, collaborative environment balancing development and release activities.
• Competitive compensation, benefits, and professional development opportunities.
• Opportunity to shape analytical strategy for an innovative biomaterials platform with clear patient impact.

Powered by JazzHR