R&D Chemist - Stability Coordinator

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.

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

• Initiating stability studies, coordinating stability pulls, making sure the testing schedule of stability samples is met, analyzing stability data, and evaluating trends, and writing stability reports.
• Authoring stability protocols, interim reports, and reports for stability studies, including routine campaign stability studies and non-routine project stability studies.
• Reporting the trending of stability data through data management and trend analysis using appropriate software.
• Escalating any trends to the R&D Manager and supporting any investigations, based on the test data collected.
• Supporting the business in requests relating to stability data (including temperature excursion assessments, regulatory requests, and investigational work).
• Owning and supporting stability related Deviations, CAPAs and Change Controls, and progressing department improvements.
• Managing stability studies following internal procedures, ensuring studies are set up per the protocol.
• Interacting with other groups in R&D and other departments (such as QC and production) as required.
• Collaborating with relevant QC laboratories to ensure stability samples are tested within their specified time frame for actives, and micro.
• Coordinating the shipment of stability samples to outside labs when required.
• Maintaining stability tracker for routine annual stability and lab st abilities.
• Having good knowledge about lab equipment/test – Viscosity; pH; specific gravity; API’s etc.
• Knowledge of cGMP regulations; GLP.
• Supporting R&D lab with formulation development for OTC;
  Cosmetic and Medical device in different forms – Aerosol; liquid and BOV.
• Improving current product formulations.
• Leading 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 equivalent combination of education and experience.
• Must demonstrate knowledge of common analytical tools and techniques.
• Must have previous experience with conducting stability studies and knowledge of statistics.
• Must have previous experience in a GMP environment.

Competitive Salary/ Pay & Packages, Vacations, Insurance, 401K, Life Insurance, Disability (Long term/ Short term), and Continuous Training.

Tri-Pac, Inc. also recognizes the importance of continuing education and offers Education Assistance to our employees to encourage continued personal development and growth.

www.tri-pac.us

Thank you for your interest and consideration of a career with Tri-Pac, Inc. Tri-Pac, Inc. is an Equal Employment Opportunity / Affimative Action Employer