Qureos Mentor

LifeSprout, Inc.

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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
 
 
 
 
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 Design, develop, and validate analytical, chemical, physical, and mechanical test methods relevant to
 
 incoming raw materials,
 
 biomaterials and finished devices.
 
 
 
 
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 Create, review, and execute method development and validation protocols, stability studies, and release testing with clear, defensible test reports.
 
 
 
 
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 Draft and maintain SOPs, QC work instructions, sampling plans, and validation documentation in accordance with GMP and ISO standards.
 
 
 
 
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 Define sampling strategies and test plans for incoming materials, in process controls, subcomponents, and finished product release.
 
 
 
 
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 Oversee QC laboratory operations including scheduling, equipment requirements, lab layout, materials management and recordkeeping.
 
 
 
 
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 Collaborate cross functionally with R&amp;D, manufacturing, regulatory, and supply chain to align testing strategy with product development and regulatory requirements.
 
 
 
 
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 Support supplier qualification and regulatory submissions by providing method validation rationale and test data.
 
 
 
 
 
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 Qualifications
 
 
 
 
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 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.
 
 
 
 
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 MS in Analytical Chemistry, Materials Science, Biomedical Engineering, Chemical Engineering, or related discipline; PhD desirable for Principal level.
 
 
 
 
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 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.
 
 
 
 
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 Experience defining sampling plans and statistical approaches for method validation and acceptance criteria.
 
 
 
 
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 Proven experience working within GMP and ISO 13485 environments, including authoring validation protocols, SOPs, and validation reports.
 
 
 
 
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 Strong technical breadth with chemical and physical characterization techniques and mechanical testing relevant to soft materials.
 
 
 
 
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 Excellent technical writing skills and experience generating protocols, test reports, and regulatory‑grade documentation.
 
 
 
 
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 Self-starter, hands-on, strong problem solving, and able to work independently and lead cross functional initiatives.
 
 
 
 
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 Preferred Qualifications
 
 
 
 
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 Experience with equipment qualification and QC lab management in regulated environments.
 
 
 
 
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 Prior involvement supporting regulatory submissions and/or audits.
 
 
 
 
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 Leadership experience mentoring scientists and technicians; stronger emphasis on people and program leadership for Principal level.
 
 
 
 
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 Working conditions and what we offer
 
 
 
 
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 Onsite presence at Baltimore, MD facility required for laboratory activities with occasional travel (&lt;10%).
 
 
 
 
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 Fast paced, collaborative environment balancing development and release activities.
 
 
 
 
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 Competitive compensation, benefits, and professional development opportunities.
 
 
 
 
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 Opportunity to shape analytical strategy for an innovative biomaterials platform with clear patient impact.
 
 
 
 
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Senior / Principal Method Development Scientist

Join LifeSprout, Inc. and explore 1   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

LifeSprout, Inc.

ABOUT_COMPANY

Senior / Principal Method Development Scientist