Manager, cGMP Manufacturing

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn.

Job Overview

We seek a dynamic, highly motivated, and experienced individual for the Manufacturing Manager, cGMP Manufacturing role.  The Manufacturing Manager will ensure production readiness and compliance initiatives are optimized and executed appropriately in GMP production. This position will be onsite at the manufacturing facility in Morrisville, NC.  This position is an exempt role and will operate on one of two shifts following a 2-2-3 schedule with the following hours: 7:00am-7:30pm on workdays that occur Sunday through Thursday and 7:00am-5:30pm on workdays that occur on Fridays and Saturdays. Weekends and holidays are required as scheduled.

Job Duties and Responsibilities

• Hire and develop a high-performing, flexible manufacturing team (approximately 10 operators) capable of meeting the manufacturing operation timeline. 
• Ensure plans and resources (people, facilities, supplies etc.) are efficiently utilized for training and to manufacture RETHYMIC and future clinical programs for on time delivery. 
• Oversee the training, development, retention, and performance of staff for the execution of manufacturing operations. 
• Closely partner with QA peers for creation of SOPs, closure of documentation, inclusive of training records, deviations, batch records and CAPAs, required for timely disposition of batches. 
• Ensure smooth production operations through proactive scheduling and planning of activities. 
• Lead efforts in scheduling personnel for follow-up and emergency production work. 
• Responsible for ensuring alarm monitoring, response, and reconciliation is performed in a timely fashion. 
• Attend and actively participate in waste walkthroughs, 5S, Gemba walkthroughs, kaizen events, or any other operations, lean six-sigma, quality, safety, or environmental training/initiatives, as required. 
• Coach operators in high quality deviation write-ups and appropriate CAPA development/effectiveness checks; drives manufacturing deviations to on-time closure and works with team to assure minimal deviations. 
• Support regular operation of manufacturing facility and responds to issues as needed. 
• Prepare for and successfully participate in internal audits and FDA inspections. 
• Prioritizes the work of others. 
• Performs other activities as required.

Key Core Competencies

• Clear communication is required with cross-functional peers daily. 
• Ability to build strong, open, collaborative working relationships with internal and external stakeholders. 
• Sound knowledge of current Good Manufacturing Practices. 
• Exceptional interpersonal skills and proven track record of teamwork, adaptability, innovation, and initiative required. 
• Strong oral/written technical communication and leadership skills are required. 
• Ability to work well with all levels of company personnel. 
• Ability to work independently with minimal supervision. 
• Capable of rapidly absorbing technical data and applying this knowledge to a pharmaceutical manufacturing environment. 
• Problem-solving experience providing consistent judgment, quality, accuracy, speed, and creativity. 
• Takes initiative in making improvement suggestions to promote operational goals.

Education and Experience