Stability Manager / Director

King of Prussia

Summary

The Stability Program Manager is responsible for the overall management of the Stability program for Center for Breakthrough Medicines manufacturing and Testing client programs.Stability programs will include early clinical through late phase, and commercial programs.The Stability Program Manager will be responsible for developing all aspects of the program, establishing the processes and tools to meet cGMP compliance and global regulatory standards.The Stability Program Manager will also be responsible for the generation, review, approval, and implementation of stability protocols and the preparation of interim and final stability reports, as well as for analysis and trending of stability data.

Responsibilities

·Develop and implement the Stability Program for Center for Breakthrough Medicines (CBM)

·Develops, manages and updates Stability Program SOPS

·Implementation of the Stability Module in CBM’s Laboratory Information Management System (LIMs)

·Manages Stability projects including customer interactions, scheduling, and finances while providing key updates to leadership

·Responsible for tracking and timely completion of stability program activities

·Schedule and organizing workload related to the Stability Program

·Tracking and reporting costs and customer charges for stability sample storage and testing

·Review and implementation of regulatory requirements for the Stability Program

  • Generation, review, approval, and execution of stability protocols
  • Generation of interim and final stability reports
  • Trending of all stability data and providing updates to senior management
  • Lead OOS investigations or OOT investigations for stability samples
  • Training of personnel performing activities as part of the stability program
  • Ensuring that all tests associated with drug substance and drug product stability studies are completed per approved CBM SOPs
  • Responsible for stability specific method transfers or validation
  • Support Assistant Stability sample coordinator with Labeling and storage of stability samples
  • Monitoring and maintenance of all stability chambers with Stability Sample Coordinator
  • Management of stability samples
  • Entry and review of stability data or tables
  • Document raw and final data to ensure complete and proper documentation according to applicable procedures and cGMPs
  • Participate in continuous improvement projects

Participates in client audits and regulatory inspections as required

Qualifications

·Excellent leadership, written and verbal communication skills and ability to influence others

·Excellent critical thinking and problem-solving skills

·Detailed and results orientated

·Excellent negotiation and facilitation skills, with strong customer-service focus

·Able to professionally handle multiple and sometimes competing priorities

·Strong aptitude for technical comprehension enabling rapid learning in a highly regulated environment

·Ability to lead multi-disciplinary project teams

·Strong understanding of pharmaceutical product development and manufacturing

·Strong knowledge of FDA regulation/ICH guidelines, U.S. drug development process and project management practices

·Proficiency in Microsoft Office programs including Word, Excel and MS Project

·Proficiency with ERP, CRM, and Documentation Systems

·Ensures accuracy and relevance of assigned training curriculum

·Drives timely completion of training for employees to meet regulatory requirements

Performance Management, coaching, mentorship, and development of employees

Education & Experience

·Bachelor’s degree in a scientific discipline required

·5-10 years of analytical experience in a GMP laboratory or research setting, including familiarity with stability testing and specifications requirements

  • Working knowledge of regulatory guidance’s for stability storage and testing
  • 4 years of experience in stability programs

4 years of technical writing experience (SOP, Regulatory submissions, technical reports)

Menu