Assistant Manager - Stability Lab

Job Summary

Responsible for overseeing all the activities of the ARD-Test Centre and R&D Stability team. Provide comprehensive project coordination support to Global Analytical Development (AD), Global Analytical R&D QC (AR&DQC) and Global Formulation Development (FD) management and personnel with regards to both new product development and Product Life Cycle Management (PLCM) processes. Ensure that stability is initiated according to priorities, and that the regulatory submissions documents (i.e. stability summary reports, executive stability reports and method validation reports & associated submission reports) are provided timely to Regulatory Affair team for submission purposes.

Job Responsibilities

• Provide leadership for the ARD-Test Centre and R&D Stability team within ARD by assigning work activities and providing guidance and coaching to team members.
• Provide comprehensive stability project coordination support to Analytical R&D teams with regards to NPD and PLCM activities.
• Plan, assign and monitor work in department in accordance with priorities and ensure that work is completed in a timely manner to meet established deadlines. Details of progress, including resource conflicts, are to be communicated to management.
• Create and maintain information system effectively monitoring project status.
• Responsible for supervision of all activities associated with the initiation of stability studies (NPD and PLCM projects), smooth operation of stability studies, and distribution of samples for testing across AD and AR&DQC.
• Liaise with other units within GRD to ensure that all information required for stability protocol is completed.
• Verify and approve stability protocols in LIMS.
• Develop and maintain R&D Stability program by ensuring that the following activities occur:
• Communicate initiation of stability studies to the GRD group
• Oversee the development and approval of protocols for stability studies
• Oversee the deletion of studies, in whole or in part from the stability plan, where justified
• Ensure that Stability Summary Reports are created and updated with new stability data.
• Interpret and summarize/trend stability data, investigate and report stability failures or abnormal trends.
• Monitor the performance of stability chambers, initiate deviations due to non-compliance and effect corrective action of the conditions, when not met. Conduct formal review of monitoring of stability chambers.
• Participate as required in project planning meetings within ARD and ARD-QC, FD-SD and with other groups such as BCD and GPM.
• Develop and maintain strong working relationships with internal and external customers through effective communication skills.
• Apply strong problem-solving skills to assess problems and develop novel ways to resolve issues and prepare for contingency plans.
• Ensure that all assigned staff conducts their work in full compliance with Good Manufacturing Practices, Good Laboratory Practices, Standard Operating Procedures, and established safety standards.
• Participate and lead performance conversations with employees, including monthly one on ones, to connect on performance; check in on employee’s progress toward achieving Objectives.
• Utilize open, honest, two-way communication to build trust-based relationships with employees, business partners and direct leader.
• Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values – Collaboration, Courage, Perseverance and Passion.
• Utilize your networks to attract and hire talent in a comprehensive, differentiated and consistent manner essential to our continued growth.
• All other duties as assigned.

Job Requirements

• Education/Experience
  • A graduate/postgraduate or Ph.D. degree in Chemistry/ Pharmacy from a recognized school/university.
• Knowledge, Skills and Abilities
  • Preferred experience in an R&D environment with a proven ability to supervise and train staff
  • Practical experiences in the testing of finished product samples is an asset.
  • Proficient in MS application software, as well as laboratory software packages.
  • Sounds knowledge of regulatory guidelines for drug product submissions and cGMP requirements for research and development.
  • Strong interpersonal, communication and organizational skills.
  • Demonstrated ability to work effectively in a team-based environment.
• Experience
  • 10+ year experience in pharmaceutical industry, preferably in R&D