Senior / Principal Scientist, QC and Analytical Development

Description: Senior / Principal Scientist, QC and Analytical Development About LifeSproutLifeSprout 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.

Responsibilities: Oversee analytical development and QC laboratory operations for biomaterials and finished medical devices. This includes designing, validating, and maintaining chemical, physical, and mechanical test methods while ensuring GMP and ISO 13485 compliance.