R&D Method & Technology Specialist- R&D Chemist

Thorne Research Inc•Summerville, SC

About The Position

At Thorne, we work to deliver high-quality, science-backed solutions to empower individuals to take a proactive approach to their well-being. Each day begins with a mission to help others discover and achieve their best health. We count on our team members to challenge and push the boundaries to make that happen. At Thorne, you’ll be joining a team of more than 750 passionate individuals committed to our cause of providing superior health solutions at every age and life stage. Position Summary: The Scientist will lead scientific oversight of raw material qualification and finished product testing for dietary supplements by managing external contract laboratories. This role ensures materials meet specifications, supports formulation feasibility and rapid innovation, and drives method robustness, data integrity, and compliance with applicable regulations (e.g., cGMP for dietary supplements, 21 CFR Part 111). The successful candidate will combine technical depth with vendor management excellence to accelerate product launches while maintaining uncompromising quality standards. Travel is 10% - 20% for supplier audits, lab visits, trials, and scale-up runs (as needed)

Requirements

MS or PhD in Chemistry, Biochemistry, Pharmaceutical Sciences, Food Science, or related discipline. BS with significant relevant experience considered.
5-8+ years in analytical testing, raw material qualification, or quality control within dietary supplements, nutraceuticals, pharma, or food.
Hands-on experience with outsourced testing and contract lab management (SOWs, SLAs, audits, method transfers).
Strong proficiency with chromatography and spectroscopy (HPLC/UPLC, GC, ICP-MS, LC-MS, FTIR, UV-Vis) and microbiological testing.
Working knowledge of 21 CFR Part 111, ISO/IEC 17025, cGMP, and data integrity (ALCOA+).
Demonstrated ability to interpret complex data and write clear technical reports.
Excellent communication, project management, timely follow up, and stakeholder engagement skills.
Willingness to engage, cold call, reach out to laboratories to develop new methods, partnerships and discuss technical details regarding testing.

Responsibilities

Raw Material & Component Qualification:
Design and execute qualification plans for new and existing raw materials, excipients, and packaging components.
Define scientifically sound material specifications (identity, purity, potency, microbiological, heavy metals, residual solvents, allergens, etc.).
Assess supplier Certificates of Analysis (CoAs) and trend material performance; initiate corrective actions when needed.
Evaluate alternative suppliers and material grades to enhance cost, performance, and sustainability.
Contract Laboratory Management:
Select, audit, and onboard contract labs; negotiate SOWs, methods, turnaround times, and SLAs.
Author and maintain test plans, protocols, and method validations/verification packages; manage transfer of methods to external labs.
Oversee sample logistics, chain of custody, and data traceability.
Monitor lab performance (quality, TAT, right-first-time); lead investigations, CAPAs, and continuous improvement initiatives.
Ensure labs operate to relevant standards (ISO/IEC 17025, cGMP, GLP where applicable).
Testing & Data Integrity:
Define testing strategies across development phases (bench-top feasibility → pilot → scale-up → commercial).
Interpret analytical results, generate technical reports, and provide clear recommendations to R&D, NPD, and Supply Chain.
Establish data governance for external data (ALCOA+ principles); manage raw data packages, electronic records, and metadata.
Lead or support method development/optimization (e.g., HPLC/UPLC, GC, ICP-MS, LC-MS, FTIR, UV-Vis, microbiology).
Innovation & New Product Development:
Partner with formulators to assess ingredient suitability, stability, and interactions; propose alternatives backed by data.
Build stage-gate deliverables: risk assessments, test plans, material readiness, and qualification reports.
Support sensory, shelf-life, and stability studies (accelerated/real-time) with contract labs.
Translate regulatory requirements and label claims into testable, defensible specifications.
Participate in project planning to ensure that analytical activities are initiated and allocated with adequate timing.
Compliance & Risk Management:
Prepare for and participate in internal/external audits; maintain inspection readiness.
Perform scientific risk assessments (e.g., contamination, adulteration, botanicals authentication, allergens).
Cross-Functional Collaboration:
Advise Procurement on supplier selection and quality agreements.
Support Operations with deviations, OOS/OOT investigations, and change controls.
Present findings to leadership; communicate risks and mitigation plans.
Additional Responsibilites:
Provide support with the drafting, writing and update of QC Laboratory documents (SOPs, WIs, TMs) and specifications (FPSs and RMSs) as needed for outsourced testing.
Work with LIMS Manager/Regulatory Business System Analyst in ensuring changes and updates to QC Laboratory documents and procedures are updated in the LIMS.
Adhere to company safety requirements, ensures laboratory compliance with safety requirements.
Verify LIMS data entries.
Is committed to impartiality and confidentiality in all aspects of laboratory activities, informs management when risks to impartiality and confidentiality are identified and supports taking steps immediately to minimize such risks.
Support maintaining the integrity of the management system as described in ISO 17025 when changes to the management system are planned and implemented.
When requested, participate in management review meetings for monitoring of continuous suitability, adequacy and effectiveness of the laboratory quality management system.
Produce accurate and consistent results; attention to detail is essential.