Senior / Principal Scientist, QC and Analytical Development

LifeSprout, Inc.; Baltimore (MD); On-site; USD 120,000 - 190,000; Full time

Benefits offered by this job

Competitive compensation

Benefits

Professional development opportunities

Job summary

LifeSprout, Inc. is seeking a Senior/Principal Scientist to lead analytical development and QC operations for biomaterials and finished devices. You will own method development, validation, and release testing, while drafting SOPs and validation documents to meet GMP/ISO 13485 standards.

The role requires hands-on expertise in analytical methods, regulatory documentation, and cross-functional collaboration to align testing strategies with product development and manufacturing quality systems.

Qualifications

• Requires hands-on experience developing and validating analytical methods for biomaterials and medical devices.
• Experience with GMP and ISO 13485 environments, including validation protocols and recordkeeping.
• Strong technical breadth in chemical and physical characterization and mechanical testing of soft materials.

Responsibilities

• Design, develop, validate analytical, chemical, physical, and mechanical test methods for biomaterials and devices.
• Draft and review SOPs, QC work instructions, and validation documentation per GMP/ISO standards.
• Oversee sampling plans, test strategies, and release testing.
• Collaborate cross-functionally with R&D, manufacturing, regulatory, quality, and supply chain.
• Lead prioritization of QC/analytic development workstreams and maintain documentation integrity.

Skills

Analytical method development

GMP / ISO 13485

Data integrity

Method validation

Statistical sampling

Regulatory documentation

Scientific writing

Education

MS in Analytical Chemistry or related field

PhD desirable for Principal level

Tools

Rheometer

Spectrophotometer

Image analysis software

QC instruments

Job description

Senior / Principal Scientist, QC and Analytical Development

About LifeSprout

LifeSprout was founded in September 2015 as a Johns Hopkins University spinout. 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 is responsible for overseeing analytical development activities and QC laboratory operations for LifeSprout biomaterials and finished devices. The position owns the identification, development, qualification, and validation of chemical, physical, and mechanical test methods across incoming materials testing, in‑process monitoring, and final release testing. The role generates and executes protocols and validation documents, drafts procedures and QC work instructions, defines sampling and test plans, and ensures day‑to‑day QC lab activities are organized, compliant, and aligned with GMP and ISO 13485 expectations.

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.
• 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.

Qualifications

• 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.

Preferred Qualifications

• 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.

Working Conditions and What We Offer

• 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.

Eligibility to work in the U.S. is required.