R&D Chemist - Stability Coordinator

R&D Chemist - Stability Coordinator - South Bend INHubot/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 in South Bend, IN.

Job Description

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.

Responsibilities

• This will include 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.
• To author stability protocols, interim reports, and reports for stability studies
• This includes routine campaign stability studies and non-routine project stability studies.
• Report the trending of stability data through data management and trend analysis using appropriate software.
• To escalate any trends to the R&D Manager and support any investigations, based on the test data collected.
• To support the business in requests relating to stability data (including temperature excursion assessments, regulatory requests, and investigational work)
• To 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.
• The Stability Coordinator will interact with other groups in R&D and other departments (such as QC and production) as required.
• Will collaborate with relevant QC laboratories to ensure stability samples are tested within their specified time frame for actives, and micro.
• Coordinate the shipment of stability samples to outside labs when required.
• Maintain stability tracker for routine annual stability and lab stabilities.
• Good knowledge about lab equipment/test – Viscosity; pH; specific gravity; API’s etc.
• Knowledge of cGMP regulations; 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.
• Lead formulation development activities with a focus on stability as the primary responsibility.
• Proficient in Microsoft office 365.
  
  

Education And/or Experience

• 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.
  
  

Benefits

Competitive Salary/ Pay & Packages, Vacations, Insurance, 401K, Life Insurance, Disability (Long term/ Short term), and Continuous Training. Work where you are HAPPY! Hubot/Tri-Pac, Inc. also recognizes the importance of continuing education and offers Education Assistance to our employees to encourage continued personal development and growth.

To Staffing & Recruitment Agencies: Our Company does not accept unsolicited CV's or applications from agencies. We are not responsible for any fees related to unsolicited CV's or applications and explicitly reserve its right to contact candidates presented in such unsolicited CV or application.

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