Job Summary
This role will oversee the day-to-day support requirements of the manufacturing operations team, providing direction, troubleshooting, and guidance while maintaining safety compliance and audit readiness.
Duties and Responsibilities
* Ensure all documentation (SOPs, Manufacturing Records, Batch Sheets & Logbooks) is current, accurate, reviewed, and in accordance with regulatory requirements.
* Manage all aspects of respective areas operations.
* Lead, motivate, and manage operation manufacturing specialist teams.
* Prepare reports by collecting, analyzing, and summarizing information and trends.
* Track relevant metrics to ensure operations are performing effectively and efficiently.
* Implement a contamination-free program to ensure highest process success rates.
* Work to the highest safety standards and supports safety initiatives and implementation of safety improvements.
* Interface with other departments, such as Facilities, Process Sciences, Regulatory, Quality Assurance, and Quality Control.
* Lead and implement process improvements and robustness initiatives.
* Prepare and present manufacturing data for review.
* Perform cGMP audits of production area. Represents manufacturing during regulatory and client audits.
* Train, develop, and mentor direct reports and effectively manage the performance of individuals.
* Work closely with staff to develop and manage individual goals and objectives.
* Conduct performance evaluations that are timely and constructive.
* Lead and implement continuous improvement initiatives.
Requirements
* 3rd Level Qualification in Life Sciences.
* 8+ years of relevant experience in manufacturing within the Biopharma industry.
* 5+ years supervisory experience.
* Excellent verbal and written communication skills.
* Problem-solving skills.
* Leadership skills.
* Proficient in Microsoft Word, Excel, PowerPoint, and Outlook.