Stability Scientist 2

What You Will Do

• Design, develop, and implement innovative stability testing protocols and accelerated stability studies, incorporating novel stress testing approaches to predict product shelf life and expedite product development timelines.
• Collaborate cross-functionally with R&D, Quality, Quality Assurance, and Regulatory teams to develop robust stability-indicating methods, support stability-related activities and submissions, and enhance product reliability.
• Utilize advanced analytical techniques and data modeling to interpret complex stability data, troubleshoot stability issues, and provide actionable insights for formulation improvements and lifecycle management.
• Continuously evaluate emerging technologies and scientific literature to integrate cutting-edge stability assessment tools into existing workflows.
• Develop, implement, and ensure adherence to protocols for stability testing in compliance with industry best practices and regulatory requirements.
• Prepare detailed and accurate stability reports for internal review and regulatory documentation.
• Manage multiple projects simultaneously, prioritizing tasks to meet deadlines and project goals effectively.
• Process and test stability samples to guarantee that they continue to conform to specifications and standard operating procedures (SOPs).
• Prepare diluents, solutions, reagents, etc. in accordance with approved SOPs, Component Specifications, Method Specifications, Protocols, and/or compendia to expedite laboratory testing.
• Participate in consumable management by performing ordering in Ariba and receipt management in LIMs.
• Ensure glassware cleaning is completed to support required laboratory operations and testing.
• Assure stability samples are stored properly and pulled on the schedule date for testing.
• Perform instrument calibrations, preventative maintenance, and daily checks in LIMS as trained.
• Review and/or assist in writing SOPs and laboratory investigations.
• Perform troubleshooting for analytical issues and investigations. Identify and implement opportunities to improve laboratory efficiencies.
• Mentor and train other chemists/scientists.
• Follow cGMPs and safety regulations.
• Maintain an environment of respect and teamwork with all coworkers.

Required Qualifications

• Bachelor's degree in Chemistry, Pharmaceutical Sciences, or related scientific discipline; advanced degree preferred.
• Minimum of 2-4 years of experience in pharmaceutical stability testing or related scientific research.
• Strong foundation in pharmaceutical sciences or related disciplines.
• Strong proficiency in data analysis software and statistical tools relevant to stability studies.
• Excellent problem-solving skills with the ability to make informed decisions independently.
• Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment.

Desired Qualifications

• Demonstrated ability to conceptualize and execute complex stability studies with a focus on innovative problem-solving.
• Proficiency in advanced analytical instrumentation and data analysis software relevant to stability science.
• Expertise in Microsoft Office suite, with advanced capabilities in Excel (including v-look up, h-look up, macros, and pivot tables) and PowerPoint for data presentation.
• Demonstrated ability to analyze syndicated data and generate comprehensive reports.
• Excellent communication skills to effectively translate scientific findings into actionable insights for multidisciplinary teams.
• Adaptability to evolving scientific challenges and a proactive approach to integrating new methodologies in stability testing.
• Passion for pioneering stability research.

Pay

Annual base salary for new hires in this position ranges: $72,675.00 - $102,600.00. This takes into account a number of factors including work location, the candidate's skills, experience, education level & other job-related factors.

Benefits

• Competitive Benefit Package
• Paid Company Holidays, Paid Vacation, Volunteer Time & More
• Learning & Development Opportunities
• Kenvuer Impact Networks