Supervisor, Chemistry and Stability

Responsibilities

• Coordinate the training and development of department personnel.
• Aid in the assignment of personnel.
• Perform personnel reviews and administer disciplinary actions as required.
• Promote a positive work environment for personnel morale and achievement of goals & objectives.
• Address personnel issues with assistance from department Management and Human Resources.
• Prioritize and track progress of daily activities in functional area for timely release of materials, products, components and/or information.
• Assure that the integrity of materials, products, components and data is maintained.
• Assure staff conformance with cGMP and FK USA procedures and policies.
• Facilitate department investigations for non-conforming materials, products and/or components.
• Support investigations and corrective/preventative actions for the Company.
• Provide technical guidance on existing and improvements to processes, products, procedures and methods.
• Assist with development and maintenance of department budget.
• Prioritize and track progress of daily activities in functional area for timely release of materials, products, components and/or information.
• Compile information required for Management Reviews and Audit Responses.
• Represent department at meetings.
• Reviews Stability Testing Protocols for accuracy and compliance.
• Reviews Stability sections of regulatory submissions prior to filing with the agency.
• Assesses impact of Material Change Requests (MCR) to current stability commitments.
• Consults with Regulatory Affairs on interpretation and execution of stability commitments.
• Tracks acquisition of lots into stability program to ensure all required batches are requested and acquired for regulatory requirements.
• Reviews stability protocols for accuracy.
• Manages approving, expiry calculation, stability summary, and archiving processes.
• Reports department metrics for Quality Management purposes as required.
• Assumes area ownership of stability chambers and is responsible for investigating excursions, initiating critical work to be performed, and assessing impact to product stored within.
• Reviews and manage the regulatory annual reports.
• Develops staff to achieve both departmental and personnel goals.
• Identifies and solves personnel issues.
• Support investigations (OOS, OOT, Deviations, Complaints, etc.) as required.

Qualifications

• B.S. in Chemistry or related Science
• Five – Ten years of progressive pharmaceutical lab experience
• Equivalent combined of education and experience in pharmaceutical manufacturing, related industrial or clinical experience accepted.
• Excellent verbal and written communication skills are essential.
• Knowledge of department processes and procedures, and a clear understanding of regulatory requirements.
• Demonstrated knowledge of Statistical analysis as it pertains to product stability and determination of shelf-life is plus.
• A demonstrated ability to lead in a team and effect solutions to accommodate competing goals.
• Flexibility, adaptability, and strong desire to work in a dynamic environment.
• Must possess skills to analyze analytical results and solve problems as a backup to Stability Manager.