R&D Chemist - Stability Coordinator

Overview

R&D Chemist - Stability Coordinator - Winchester, VA
, Hubot Tri-Pac, Inc., a contract development and manufacturing company (CDMO) specializing in liquid and aerosol filling for personal care and pharmaceutical marketers, is seeking an experienced R&D Chemist-Stability Coordinator to join our fast-growing team immediately. This position is onsite and located in Winchester, VA.

Job Description

The R&D Chemist
-Stability Coordinator is responsible for coordinating and supporting the site stability program, formulation, and stability sampling activities in compliance with FDA ICH guidelines, company quality guidelines, SOPs, and other regulatory requirements. This position will work well with cross-functional teams and serve as the key point of contact for all stability programs for OTC, Medical Device, and Cosmetic products.

• Initiate stability studies, coordinate stability pulls, ensure the testing schedule of stability samples is met, analyze stability data, evaluate trends, and write stability reports.
• Author stability protocols, interim reports, and reports for stability studies.
• Manage routine campaign stability studies and non-routine project stability studies.
• Report trends in stability data through data management and trend analysis using appropriate software.
• Escalate trends to the R&D Manager and support investigations based on test data collected.
• Support the business in requests relating to stability data (including temperature excursion assessments, regulatory requests, and investigational work).
• Own and support stability-related Deviations, CAPAs, and Change Controls, and progress department improvements.
• Manage stability studies following internal procedures, ensuring studies are set up per the protocol.
• Interact with other groups in R&D and other departments (such as QC and production) as required.
• Collaborate with QC laboratories to ensure stability samples are tested within their specified time frame for actives and microbiology.
• Coordinate the shipment of stability samples to outside labs when required.
• Maintain stability tracker for routine annual stability and lab st abilities.
• Proficient knowledge of lab equipment/test parameters (e.g., viscosity, pH, specific gravity, APIs).
• Knowledge of cGMP regulations and GLP.
• Support R&D lab with formulation development for OTC, Cosmetic, and Medical Device in different forms (Aerosol, liquid, and BOV).
• Improve current product formulations and lead formulation development activities with a focus on stability as the primary responsibility.
• Proficient in Microsoft Office 365.

• Associate or bachelor's (B.A. or B.S.) in a scientific discipline; and 2 or more years related experience and/or training; or an equivalent combination of education and experience.
• Demonstrated knowledge of common analytical tools and techniques.
• Experience conducting stability studies and knowledge of statistics.
• Experience in a GMP environment.

Competitive salary and compensation package, vacations, insurance, 401K, life insurance, disability (long term/short term), and continuous training. Work where you are happy. Tri-Pac, Inc. also recognizes the importance of continuing education and offers education assistance to employees to encourage continued personal development and growth.

Tri-Pac, Inc. is an Equal Employment Opportunity / Affirmative Action Employer.