Job Overview:
* As a key member of the operations team, you will contribute to the development and implementation of processes for the manufacture of biologics and vaccines.
* You will serve as a subject matter expert in sterile manufacturing and provide input to company-wide standards and guidelines.
* Support team members in their professional growth and ensure they receive necessary training and development opportunities.
* Develop and maintain comprehensive training programs that align with business objectives.
* Collaborate with team members to set goals and priorities that support site-wide initiatives.
* Foster an environment of continuous improvement, encouraging open communication and feedback to optimize aseptic manufacturing processes.
* Provide regular coaching and feedback to help team members improve their skills and performance.
* Lead the development and execution of media fill simulations to validate process control.
* Ensure compliance with cGMP regulations and industry best practices in daily operations and job functions.
Key Responsibilities:
* Aseptic manufacturing and process development
* Sterile manufacturing expertise
* Team member training and development
* Training program management
* Goal setting and prioritization
* Continuous improvement and feedback
* Media fill simulation leadership
* cGMP compliance