The operations manager will play a pivitol role in the design, start-up, and verification of the Stage 2 GTx manufacturing facility in Sanford, NC. The incumbant will review and approve user requirements and design specifications, support fit for use activities (FAT, commissioning, verification), and serve as a subject matter expert in multiple unit operations. As the project transitions to operations, the operations manager will lead a team of direct reports and have direct accountability for all aspects of operations in an assigned drug substance or drug product area of the facility which includes production, maintenance, verification, and equipment/facility changes as well as development of leaders and technical experts who work in the area. Although the incumbent may be hired with responsibility for a primary area, they are expected to quickly learn new processes as needed to support program timelines. The incumbent works with minimal direct supervision and is responsible for the right first time execution of manufacturing processes, continuous improvement of business and GMP processes, technical leadership in multiple areas of manufacturing operations, and development and growth of operations staff. The incumbent should also have knowledge of CMC requirements and past participation in regulatory inspections. The operations team lead must also comply with applicable safety, occupational health, loss prevention and environmental requirements.
Provide input into equipment design that meets process and operations requirements standardized, simple, reproducible. Ensure overall operability of Stage 2 upstream operations.
Oversee development of GMP documentation required for GTx operations. Partner with Stage 1 to ensure continuity in operations across Stage 1 and 2 Develop and execute hiring and training plan for new Stage 2 colleagues.
Approve project documents.
Deliver the plan for operational readiness on-time, without injury, and with demonstrated improvement batch over batch.
Maintain the accuracy of all documentation needed for operations including SOPs, batch records and compounding records.
Develop lean culture through the deployment and integration of lean philosophys and tools into operations to drive efficiency, minimize defects, and reduce the potential of human error.
Champion 5S, standard work, visual management, special cause and common cause problem solving in area.
Grow and develop leaders in operations through role modeling OWNIT! behaviors, transferring wisdom of manufacturing operations, and providing timely and actionable coaching and feedback.
Partner with EHS to build processes, tools, and mindsets that ensure a zero injury workplace.
Provide technical expertise on multiple manufacturing unit operations and processes across the gene therapy facility.
Proactively implement improvements to business and manufacturing processes that improve flexibility, eliminate waste, and reduce variability.
Author and approve quality and safety investigations and implementation of CAPA. Develop and execute a robust operator care program.
Bachelor's or Master's degree in Life Science, Engineering, Business Management or other related technical degree required.
Minimum of 8 years of relevant pharmaceutical manufacturing experience required.
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact required.
6 years pharmaceutical manufacturing experience with advanced degree preferred.
4 years of direct supervisory experience preferred.
Experience in project start-up preferred.
Experience in mammalian cell culture manufacturing, and single use technology preferred.
Leadership & Operational experience in manufacturing preferred.
Demonstrated ability to interact effectively with colleagues at all levels of the organization, including senior internal and/or external personnel on matters often requiring coordination between organizations.
Effective written and verbal communication skills.
Flexible and adaptable to changing priorities, meeting deadlines, and working well under pressure.
Ability to facilitate solutions to complex problems which requires the use of ingenuity, innovation, and creativity Capable of working independently and multi-tasking.
Strong computer skills required
Proven cross-functional exposure to at least two of the following areas: Engineering, Technology, Manufacturing, Quality or Materials Management, in the pharmaceutical or biotech industry Experience in dealing with regulatory bodies.
Some standing, ladder climbing, bending, pushing and lifting (up to 40 lbs.) may be required on a daily basis when the colleague is supporting work in manufacturing. Other job functions require working in an office setting where sitting and computer usage would be the norm.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
It will be necessary to work in areas that require aseptic gowning for extended periods of time.
Project start-up requires intensive milestone driven schedule, and eventual support of a 24/7 manufacturing operation. Some overtime may be required including some infrequent weekend work.
The position may require working on the floor in manufacturing or utility areas at times which will require a focus on safety. Occasional travel to support project work will be required.
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EEO & Employment Eligibility
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