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 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.

　　Job Description

　　Lilly unites caring with discovery to create medicines that make life better for people around the world. Lilly is a fortune 500 company that has been in operation for over 140 years. We make medicine with safety first and quality always while living our company values of Integrity, Excellence, and Respect for People. We’re looking for people who are determined to make life better for people around the world.

　　Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility located in Concord, North Carolina. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site and technical organization from the ground up.

　　The Technical Services/Manufacturing Science (TS/MS) Associate Director - Parenteral is responsible for the staffing, training, and leadership of the TS/MS Parenteral group. This TS/MS group provides technical leadership for syringe filling and visual inspection for commercially manufactured products targeted for transfer to the Concord site.

　　The Associate Director will be responsible for supporting the day-to-day TS/MS activities as well as planning for the 3-6-month horizon. The TS/MS Associate Director is expected to lead by example and provide coaching to others in the areas of safety, quality, technical capability, and continuous improvement.

　　Key Objectives / Deliverables:

　　Understand the scientific principles required for manufacturing parenteral drug products including the interaction of the chemistry, equipment, aseptic processes, and container closure systems.

　　Support Site Leadership to build a diverse and capable TS/MS organization, supporting the parenteral operations.

　　Deliver equipment, lines, and supporting systems through technology transfer, process validation, and control strategy development.

　　Provide leadership and develop objectives to deliver business plan goals as it relates to safety, quality, and process effectiveness and efficiency.

　　Determine staffing and resource needs to support site TS/MS requirements.

　　Maintain metrics to measure performance against business objectives and make necessary changes to improve performance.

　　Provide technical guidance to the TS/MS Parenteral group.

　　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).

　　Support site inspection readiness and execution. This role has direct interaction with Regulatory Agencies during site inspections.

　　Understand and influence the manufacturing control strategy for the various operational areas.

　　Manage external contracts/resources and project management resources, as needed.

　　Review and approve GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols and summary reports, PFDs, APRs, etc.

　　Work cross-functionally with the area process teams for metrics reviews, operational support, and issue / deviation management.

　　Drive control, capability, productivity, and continuous improvement for the process.

　　Support and/or lead TS/MS technical projects to ensure a successful start-up, improve process control, yield, product quality and/or productivity.

　　Serve as technical interface external to the Concord site.

　　Work within or lead cross-functional teams in positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives.

　　Network and collaborate with global and other parenteral sites to understand best practices, share knowledge, and participate in tactical and strategic business planning.

　　Ensure a safe working environment through compliance with safety rules and improving safety culture by actively participating in safety-related activities.

　　Minimum Requirements:

　　BS, MS, or Doctorate in Biochemistry, Chemistry, Pharmacy, Pharmaceutical Sciences, Biochemical Engineering, Chemical Engineering, or other related scientific discipline

　　Minimum 5 years of experience in a regulated industry, preferably pharmaceutical manufacturing

　　Previous management or leadership experience, including leading or working effectively with a cross functional group

　　Additional Preferences:

　　Strong technical aptitude and ability to train and mentor others

　　Excellent interpersonal, written, and oral communication skills that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organization

　　Solid understanding of basic requirements of regulatory agencies such as the FDA, DEKRA, and OSHA.

　　Experience supporting cGMP manufacturing (specifically within operations, technical services/MSAT, quality assurance, etc.)

　　Previous experience with combination products, drug product formulation and filling in aseptic environment

　　Previous facility or area start up experience

　　Previous equipment qualification and process validation experience

　　Previous experience with highly automated parenteral manufacturing processes including isolators, automated inspection, etc.

　　Previous experience with deviation and change management systems including Trackwise

　　Other Information:

　　Role is Monday through Friday based. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hour and/or off-hour work may be required.

　　Position will be based out of Concord site with ability to travel to Indianapolis and other global Lilly sites, as required

　　Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( [email protected] ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

　　Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

　　Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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