Lab Technician/Scientific Associate

Responsibilities

• Lead, mentor, and develop a team of 20+ manufacturing managers and associates, focusing on driving high performance, fostering employee engagement, and ensuring overall job satisfaction.
• Manage the evaluation, implementation and execution of electronic systems, ensuring seamless integration with existing processes and driving operational efficiency across the team.
• Oversee capacity utilization and modeling for GMP suites, equipment, and personnel, optimizing resources to ensure maximum efficiency and meet production goals. This includes potentially evolving shift scheduling from the current 5/8+dynamic scheduling to fit-for-purpose models based on forecasted demand.  
• Coordinate with Process Development, Quality Control, Quality Assurance, and Project Leadership to ensure timely completion of all Technical Transfers.
• Drive continuous improvements in all Manufacturing operations, focusing on enhancing quality and safety standards.
• Serve as Manufacturing Lead for audits, inspections, submissions and regulatory requests.
• Ensure timely close out of all deviations, CAPAs, and change controls related to all Manufacturing Processes.
• Maintain a high level of compliance through effective monitoring and reporting of key metrics to CTMC’s Quality Council.
• Develop innovative approaches to improve effectiveness of training program for manufacturing staff to enable rapid onboarding as well as overall operational flexibility through cross-training.
• Promote a culture of continuous improvement, collaboration, and safety, while leading by example to maintain a productive and secure work environment.
• Enhance existing relationships with local organizations (i.e. community colleges) to create a talent pipeline
• Other duties as assigned. 

Qualifications/Skills

• Bachelor’s degree in scientific field, or equivalent education and experience.
• 12+ yrs. experience in a related manufacturing environment (cell therapy or biotech)
• 6+ yrs. experience in management or supervisory role. 
• Preferred- 5+ Yrs Exp in Experience with Cell Therapy, including troubleshooting processing and equipment
• Previous experience with implementation or use of an ERP, LIMs, CMMS, or MES systems
• Strong knowledge of GMP Practices and FDA requirements required.
• Strong organizational skills to efficiently lead an organization of 20+ personnel.
• Previous experience with personnel growth and development plans including periodic and annual reviews. 
• Previous experience in technical authoring, including SOPs, batch records, protocols and technical reports.
• Able to understand and follow personnel flows, cleaning procedures, gowning requirements and other procedures defining requirements necessary to ensure cGMP compliant operations of cleanroom facilities.
• Able to establish new systems or processes to achieve manufacturing goals and reduce workplace error.
• Able to take on ancillary cross-functional projects and drive to completion.
• Proficient with Microsoft Office: Word, Excel, Outlook and Teams.
• Able to assist and be on call in a flexible schedule including nights, weekends, and holidays.