Employment Type: Permanent Position

Job Category: Biomanufacturing

Department: Manufacturing

Reports To (Position): Head of Technical Operations

Job Number: 2962724

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 the company'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.

Working Conditions, Equipment, Physical Demands

The incumbent in this position works in an office environment. The incumbent in this position will use the following equipment and shall have the following physical demands:

Equipment- Computer, printer, fax, and telephone.

Physical Demands- Prolonged periods of sitting at a desk and working on a computer and must be able to lift up to 15 pounds at times. In addition, ability to sterile-gown and perform activities in the manufacturing suite as well as raw material area when applicable.

The physical demands and work environment that have been described are representative of those an employee encounters while performing the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions in accordance with the Americans with Disabilities Act.

The above job description is an overview of the functions and requirements for this position. This document is not intended to be an exhaustive list encompassing every duty and requirement of this position; your supervisor may assign other duties as considered necessary.

Relocation Assistance: Yes