Location: Indianapolis,IN, USA
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.
The Sr. Director will serve as the owner of the lifecycle management strategy for all Lilly component molds. Responsibilities include implement press management strategy at Contract Manufacturers, evaluating performance, controls, and designs for commercialization projects, influencing the strategy for maintaining the qualified state of test systems used in support of device and cartridge analytical methods. This position will also ensure that test methods remain in a validated state and transferred appropriately to internal/external sites. This position will serve as the central reference for critical investigations for molded component issues and will broadly influence the network to assure device product systems are robust and well controlled. The Sr. Director will require a deep understanding of manufacturing controls, including design/build/test, DOEs, statistics, critical attributes, control strategy, test methods, and specifications.
**Responsibilities:**
+ Develop and implement a Lifecycle Management strategy for all Lilly dry-side component molds ($1B+).
+ Influence and optimize the strategy for press management to determine if/when dedicated presses are pursued at the CMs (Contract Manufacturers).
+ Ensure sufficient performance, controls and design for commercialization projects related to molding and methods.
+ Drive and influence the strategy for maintaining the qualified state of test systems used in support of device and cartridge analytical methods.
+ Serve as the central reference for critical investigations and troubleshooting related to molded components & test methods. Establish effective systems to develop procedures across the network and at CMs.
+ Develop metrics to confirm progress to objectives, particularly for capability, test methods/systems, and CM Performance
+ Influence broadly with effective relationships with internal network, and contract manufacturers to assure device product systems are robust, well controlled, and issues are appropriately resolved.
+ Serve as a member of the IDM Lead Team, Quality Lead Team, Science and Engineering Lead Team, Commercialization Lead Team, Device Safety Lead Team, and HSE Lead Team.
+ Partner with IDM-Lead Team associates to improve IDM business success.
+ Complete the HR processes for the area (PM planning and execution, employee coaching and development, recruiting and succession planning)
+ Build and implement Strategic and Business plans.
+ Ensure all manufacturing activities comply with cGMPs, regulatory commitments, and Lilly Functional Standards, maintaining inspection readiness at all times. Participate in site regulatory interactions, readiness reviews, and inspections.
**Basic Qualifications:**
+ Bachelors Degree in Engineering, Science, or related field
+ 10+ years' experience in medical device manufacturing, device research and development, or equivalent regulated manufacturing/development.
+ 5+ years demonstrated leadership experience in a manufacturing role, with the ability to work multi-functionally and across sites.
+ Deep understanding of pharmaceutical manufacturing controls, including design/build/test, DOEs, statistics, critical attributes, control strategy, test methods, and specifications.
+ Understanding of mechanical engineering concepts and device manufacturing principles (e.g. discrete manufacturing, FMEA, risk management, tolerance stacks, etc.) and injection molding
+ Detailed understanding of GMPs and understanding of device regulations and their applicability
+ Ability to lead and influence across diverse groups (functions, geographies, networks, cultures, etc.) and work collaboratively across boundaries.
+ Strong decision making, coaching and mentoring skills.
+ Excellent interpersonal, written, and oral communication skills that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organization and influence others.
+ Very strong system thinking skills and demonstrated learning agility.
**Additional Skills/Preferences:**
+ Previous experience with plastic injection molding preferred.
**Additional Information:**
+ This position is located on the LTC-North Campus and requires onsite presence a minimum of 3 days per week.
+ This position requires frequent travel US and OUS (approx. 10-20%) to coordinate between various manufacturing sites and partners.
+ Safety equipment (PPE) and precautions required in the manufacturing plant environment.
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 ( ...@lists.lilly.com ) 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.
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