Lilly Sr Director - Technical Services / Manufacturing Science in Concord, North Carolina
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
The Technical Services / Manufacturing Science (TS/MS) Sr Director is responsible for providing leadership to the TS/MS function for the Lilly Concord site. This includes implementing and overseeing the control strategy aspects of the parenteral, device assembly, and packaging operations. Additional responsibility includes establishing and implementing the organization’s functional agenda in alignment with the business and strategic plan priorities. The TS/MS Sr Director is a member of the Concord Site Lead Team.
Active member of the Concord Site Lead Team ensuring safety, quality, and operational excellence.
Provide Health, Safety and Environmental (HSE) and Quality leadership for areas of responsibility. Ensure function meets cGMP requirements. This role has direct interaction with Regulatory Agencies during site inspections.
Support Site Leadership to build a diverse and capable site organization. Talent management, development, and retention within the Concord organization (and beyond).
Provide site functional leadership and develop objectives to deliver Business and Strategic Plan Goals as it relates to safety, quality, and technical effectiveness and efficiency.
The start-up and compliant manufacturing of Concord products including implementation of the process control and validation strategy. The scope of the role includes those commercially manufactured and targeted for Concord in the device assembly, packaging, and parenteral filling operations.
Understand the scientific principles required for manufacturing parenteral drug products, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems. Lead risk management activities as it pertains to products
Lead technical operational readiness from a control strategy perspective transitioning from project to running mode. Support the delivery of equipment and supporting systems through user requirements, design, build, commissioning, qualification, validation, and subsequent operation.
Support and/or lead TSMS technical projects to ensure a successful start-up, improve process control, yield, product quality and/or productivity. Implement process changes and improvements through the tech agenda
Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability
Develop local processes and procedures for the TS/MS function
Ensure that an accurate instruction set (tickets & procedures) describes the process as performed and the control strategy for the discrete manufacturing steps.
Ownership of the Site Validation Plan and lead site validation efforts
Ownership of the Site Sterility Assurance Program
Drive stability strategy for Concord products
Ensure the function is aligned and driven to meet production throughput goals including daily operation, deviation and change management, variability reduction, and equipment/system reliability.
Develop and maintain metrics to measure performance against business objectives and make necessary changes to improve performance.
Active leadership in the implementation of Lean principles and the site Value Stream Map
Partner with Engineering, Quality and Operations leadership meet deliver operational results.
Participate in the development and implementation of strategies associated with the area sponsoring or supporting the following initiatives: Continuous Improvement, Root Cause Analysis (RCA), and Failure Modes Effect Analysis (FMEA).
Represent Concord capabilities to an increasing global customer base, other Lilly sites and corporate groups.
Requirements (Education, Experience, Training):
cGMP manufacturing experience
Technical management or leadership experience including leading or working effectively with a cross functional group
Excellent interpersonal, written and oral communication skills
Strong technical aptitude and ability to train and mentor others
Ability to handle multiple competing priorities
Bachelor’s Degree in chemistry, engineering, biology, or similar field
Advanced technical degree preferred
Preferred attributes but not required:
Demonstrated regulatory inspection experience
Experience working with parenteral manufacturing
Previous facility or area start up experience
Previous experience with combination products, device assembly, pharmaceutical packaging, drug product formulation and filling in aseptic environment
Previous equipment qualification and process validation experience
Previous experience with deviation and change management systems including Trackwise
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