Stability Scientist 2

About the Role

The Stability Scientist 2 is responsible for analyzing and interpreting stability data, designing and conducting stability studies, and preparing quality reports to support regulatory submissions. You will prioritize tasks to ensure timely project completion while making informed decisions to solve moderately complex problems.

Key Responsibilities

• 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 from $72,675.00 to $102,600.00. This takes into account a number of factors including work location, the candidate's skills, experience, education level, and other job-related factors.

Benefits

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