Senior​/Principal Method Development Scientist

Senior / Principal Method Development Scientist

About Life Sprout

Life Sprout was founded in September 2015 as a Johns Hopkins University spinout and located in Baltimore, MD. We are a medical device company creating revolutionary products for aesthetic and reconstructive medicine. Our synthetic biomaterial platform mimics the look and behavior of native tissue and is being developed into a suite of products to restore form and function for millions of patients with soft tissue loss from aging, cancer, and metabolic disease.

The company is led by a management team experienced across business, clinical, and scientific disciplines.

Role Summary

This hands-on role owns identification, development, qualification, and validation of chemical, physical, and mechanical test methods for Life Sprout biomaterials and finished devices across incoming materials testing, in-process monitoring, and final release testing. The position generates and executes protocols and validation documents, drafts procedures and QC work instructions, defines sampling and test plans, and oversees day-to-day QC lab operations in a GMP regulated environment.

Key Responsibilities

• 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.
• Oversee QC laboratory operations including scheduling, equipment requirements, lab layout, materials management and recordkeeping.
• Collaborate cross functionally with R&D, manufacturing, regulatory, and supply chain to align testing strategy with product development and regulatory requirements.
• Support supplier qualification and regulatory submissions by providing method validation rationale and test data.

Qualifications

• Hands on experience developing methods for biomaterials characterization, such as image based morphological measurements, particle size/geometry, spectrophotometry based chemical analysis and physical/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 hands on experience developing and validating analytical and physical/mechanical methods for biomaterials or medical devices;
  Principal level 8+ years with demonstrated leadership on complex method 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 validation protocols, SOPs, and validation reports.
• 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, hands-on, strong problem solving, and able to work independently and lead cross functional initiatives.

Preferred Qualifications

• Experience with equipment qualification and QC lab management in regulated environments.
• Prior involvement supporting regulatory submissions and/or audits.
• Leadership experience mentoring scientists and technicians; stronger emphasis on people and program leadership for Principal level.

Working conditions and what we offer

• Onsite presence at Baltimore, MD facility 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.