Tract Bio, located in The Pearl Innovation District in Charlotte, NC, is pioneering a new frontier in regenerative medicine, cancer and inflammatory research by developing targeted therapies for disease-causing stem cells. Our proprietary stemECHO platform enables the isolation and therapeutic targeting of previously undetected epigenetically unique disease-causing stem cells, unlocking novel treatments for inflammation, metaplasia, and cancer.

Job description:

Bioanalytical Scientist responsible for developing, qualifying, and validating analytical methods to support drug substance and drug product across discovery and development. This role designs and executes phase‑appropriate testing, interprets complex data, and ensures alignment with GLP, cGMP, and regulatory expectations. The position oversees release and stability testing, authors technical reports, and supports CMC documentation. A central responsibility is managing external CROs, including selection, contracting input, technical oversight of method development, transfer and validation, data review, and ensuring high scientific quality, timelines, and budgets. The chemist collaborates with cross‑functional teams to resolve issues and guide program decisions. Key Responsibilities Develop, optimize, qualify, and validate stability‑indicating analytical methods for drug substance and drug product using techniques such as

HPLC/UPLC, LC

‑MS, GC, and spectroscopic methods. Design and execute phase‑appropriate release and stability studies, including protocol development, data trending, and shelf‑life/re‑test period justification in alignment with ICH guidelines. Manage analytical activities at CROs/CDMOs, including method development, transfer, validation, routine release and stability testing, deviation/OOS/OOT investigations, and CAPA follow‑up. Review and approve analytical protocols, methods, raw data, CoAs, and technical reports to ensure scientific integrity, data integrity, and compliance with GLP/cGMP and internal quality systems. Serve as analytical SME on CMC teams, providing input to control strategies, specifications, and risk assessments across development stages. Support preparation of CMC regulatory documentation by drafting and reviewing analytical method, validation, and stability sections for IND/IMPD/NDA/MAA and responses to regulatory questions. Oversee reference standard qualification and lifecycle (inventory, characterization, (re)qualification) across internal and external testing sites. Maintain accurate, contemporaneous documentation and ensure all work is performed in accordance with applicable SOPs, cGMP, GLP, and safety requirements. Required Qualifications PHD degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or related discipline. Hands‑on expertise with chromatographic and spectroscopic techniques (e.g., HPLC/UPLC, LC‑MS, GC, UV, dissolution) including method development, qualification, and validation. Demonstrated experience supporting phase‑appropriate release and stability testing under GLP and/or cGMP, with working knowledge of ICH and relevant regulatory expectations. Proven experience managing or closely collaborating with external CROs/CDMOs for analytical development, method transfer/validation, data review, and issue resolution while tracking budgets and timelines. Strong data analysis and scientific writing skills, with the ability to author study protocols, technical reports, and CMC sections for regulatory filings. Excellent organizational and communication skills, and ability to work effectively on cross‑functional project teams in a fast‑paced, entrepreneurial environment.

Job Type:

Full-time Pay:

$100,000.00 - $120,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Paid time off Relocation assistance Vision insurance

Education:

Doctorate (Required)

Experience:

Chromatographic and spectroscopic techniques : 2 years (Preferred) Ability to

Relocate:

Charlotte, NC 28204: Relocate before starting work (Preferred)

Work Location:

In person