Associate Director - TS/MS Device & Packaging

Eli Lilly and Company; Indianapolis (IN); On-site; USD 118,000 - 174,000; Full time

Job summary

Join Eli Lilly as the Associate Director of Technical Services/Manufacturing Science to lead operational excellence in drug product manufacturing. In this pivotal role, you'll mentor staff, oversee device assembly processes, and drive innovation while ensuring regulatory compliance. This opportunity is tailored for leaders looking to make a significant impact within the healthcare sector.

Benefits

Comprehensive benefit program including medical and dental

401(k) and pension eligibility

Flexible spending accounts

Employee assistance program

Fitness benefits and employee clubs

Qualifications

• 5+ years of manufacturing experience in the pharmaceutical industry.
• 3+ years of demonstrated leadership skills.

Responsibilities

• Lead and develop team to foster a culture of continuous improvement.
• Ensure compliance with regulatory standards and manage operational excellence.
• Oversee technology transfer and process optimization initiatives.

Skills

Leadership

Technical Excellence

Problem-Solving

Collaboration

Communication

Education

Bachelor's degree in Science, Engineering, or related field

Job description

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.

Position Brand Description:

Join our elite team at Eli Lilly as we achieve drug product manufacturing and commercialization excellence. As the Associate Director of Technical Services/Manufacturing Science (TS/MS) in the Device and Packaging Network, you will lead the charge in ensuring operational excellence and driving technical innovation to the floor level. This role is pivotal in overseeing the commercialization mission for the site, adhering to Manufacturing Standard for Operational Excellence (MSOE) and helping to deliver the functional, strategic and business plans of the site. Your leadership will be instrumental in mentoring a technical staff and overseeing device assembly processes to ensure control and capability.

Key Objectives and Deliverables:

Empowerment through Development: Lead, mentor, coach, and develop staff, fostering a culture of continuous improvement and operational excellence for safety, quality, and technical capability.

• Technical Excellence: Lead and provide technical and effective process support services for production issue resolution and investigations, ensuring reliable solutions, safe execution, and regulatory compliance. Foster knowledge sharing and education within the team and with key internal partners to drive alignment and meet manufacturing goals.
• Innovation and Problem-Solving: Foster a culture of innovation and creativity, encouraging team members to identify and drive improvement opportunities. This position may deliver equipment, lines, and supporting systems through technology transfers, control strategy development, or process validations. Oversee and implement the organization’s technology transfer agenda, ensuring seamless integration and replication of Site business and Quality Systems for Commercial Launch/Technical Agenda activities.
• Collaborative Leadership: Represent the team on plant flow teams, influencing technical agendas and driving operational results. Collaborate closely with cross-functional teams, external partners, central functional organizations, and suppliers to drive alignment and resolve escalated issues.
• Resource Management: Manage resources effectively, including workload optimization and staffing needs, to meet business objectives. Support Site Leadership to build a diverse and capable organization, supporting the areas of device assembly and packaging.

Strategic Planning:

Engage and support business plan objectives while tracking team performance and ensuring adequate resources are in place for successful implementation.

• Safety and Quality Culture: Lead by example in building and driving a culture of safety first and quality always within the organization while removing barriers to team performance. Review and approve GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols and summary reports, PFDs, APRs, etc.
• Performance Metrics: Develop and communicate department metrics to drive continuous improvement and ensure alignment to business goals. Develop team goals for safety, quality, and process effectiveness and efficiency.
• Regulatory Compliance: Ensure adherence to current regulatory requirements, including cGMP standards, OSHA regulations, and environmental sustainability goals. Support site inspection readiness and execution. This role has direct interaction with Regulatory Agencies during site inspections.
• Process Optimization: Develop local processes and procedures to enhance efficiency and effectiveness, utilizing lean tools for success. Ensure process monitoring of critical parameters occur and reactions to signals/trends are appropriate to drive control, capability, productivity, and continuous improvement for the process.

Minimum Requirements:

• Bachelor’s degree in Science, Engineering, or related field.
• 5+ years of manufacturing experience, pharmaceutical or regulated industry.
• 3+ years demonstrated leadership skills with a history of successful team development.

Additional Preferences and Information:

• Knowledge of cGMP requirements in medical device manufacturing, highly preferred.
• Experience in device assembly and/or packaging.
• Understanding of basic requirements of regulatory agencies such as the FDA, DEKRA, and OSHA.

• Safety equipment (PPE) and precautions required in the manufacturing plant environment.
• Occasional travel may be required to support business needs.
• Previous equipment qualification and process validation experience.

• Previous experience with deviation and change management systems including Trackwise.
• Responsible for maintaining a safe work environment and supporting all health, safety, and environmental goals.
• Excellent interpersonal, written, and oral communication skills that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organization for decisions, influencing, coaching and mentoring.

This position offers a unique opportunity to lead technical excellence in device manufacturing and commercialization. You'll be at the forefront of innovation, driving impactful change while ensuring compliance with regulatory standards. If you're ready to take on a challenging yet rewarding role where your leadership can make a real difference, join us at Eli Lilly and lead the way in transforming the future of healthcare.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$118,500 - $173,800

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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