Senior / Principal Method Development Scientist

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Senior / Principal Method Development Scientist

About LifeSprout

LifeSprout 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 LifeSprout 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

Hand 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.

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