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.
Overview:
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
The PIP role provides leadership and functional-area expertise at the designated Contract Manufacturer site, in conjunction with API EM contract manufacturing personnel working at Lilly affiliate sites (e.g., Indianapolis, Kinsale, Puerto Rico) to achieve the reliable and compliant manufacture of API drug substance that meets predetermined global quality standards.
A strong understanding of manufacturing principles, operations, and project management is required for the role. The position requires knowledge of cGMPs and corporate/industry standards. The position requires working cross-functionally within the site and other functions to deliver on operational objectives.
Overall, the PIP role is responsible for:
- Day to Day production support
- Monitoring ongoing production support (e.g., production meeting attendance)
- Periodic housekeeping / fit & finish walk-throughs with area management
- Tracking of resolution of identified issues
- Practice vs procedure walkthroughs with management
- Leader of the Lilly process team and participate in applicable PLOTs
- Effective management of internal and external stakeholders
- Adhering to Lilly’s Business, Quality, and Financial Systems
Outline of Role:
Associate Director, Joint Process Team (JPT) is responsible for leading a cross functional team comprised of both Lilly and Active Pharmaceutical Ingredient (API) Contract Manufacturer representatives as part of the API External Manufacturing (API EM) site. This role is based in Switzerland and reports into the Sr. Director – External API Manufacturing Peptides Operations. The Associate Director, JPT is the key business relationship owner with the of Contract Manufacturer and is required to build & leverage relationships at all levels to ensure projects and materials are delivered on time and within downstream customer expectations. The Associate Director, JPT will partner with Lilly’s Process Research & Development group on commercialization (technology transfer, process validation and regulatory approval) of Lilly’s exciting leading pipeline and will be a member of the Flow Team.
Key Responsibilities:Â
- Lead cross-functional Joint Process Teams to develop and achieve strategically aligned objectives (related to safety, quality, reliable supply and technology transfer) at the Contract Manufacturer
- Lead internal process teams (IPTs) to enable successful completion of joint Lilly- Contract Manufacturer objectives
- Successfully facilitate and champion quality, technical, and regulatory compliance at the Contract Manufacturer
- Oversee production, batch release and shipment/supply chain schedules to ensure reliable supply
- Facilitate Joint Steering Committee (JSC) meeting agendas with significant issues escalating from the JPT and strategic topics that require alignment from both Lilly and the Contract Manufacturer
- Accountable for Contract Manufacturer performance metrics in line with Lilly’s Global Contract Manufacturing Standards
- Liaise with senior management levels in Manufacturing, Quality, Development and commercial Business Units as required
- Partner with Global Procurement and Manufacturing Strategy on due diligence and sourcing activities
Key Attributes:
- Business Knowledge: Relevant experience in the business and demonstrated performance in delivery. Looks at better, simpler ways, takes initiative and will run proactively with actions. Demonstrated self-management, prioritization and organizational skills.
- Learning Agility and Curiosity: High learning agility and flexibility, and ability to deal with ambiguity and uncertainty. Demonstrated ability to identify and prioritize problems, develop and implement solutions.
- Positive Influence: Demonstrated ability to address issues as they arise and take action in a positive collaborative manner. Trusted in the team to follow through on actions. Is interested in own performance and seeks feedback to improve.
- Relationship Builder: Demonstrated ability to establish and maintain relationships across all levels in the organization and externally. Â Demonstrated ability to listen and understand individual perspectives.
- Ability to Lead People: Demonstrated ability to lead and motivate in a team environment and a strong interest and passion for leading people. Demonstrated ability to influence peers and across functions.
- Communication: Demonstrated strong communication skills, written and oral in 1:1 and group situations.
- Decision Making: Demonstrated ability to be decisive and make well informed decisions for the benefit of the team. Demonstrated ability to collate required information and ask the appropriate questions of peers to get to the best solution.
Educational Requirements:
- Minimum bachelor’s degree in a scientific or engineering discipline
Additional skills/preferences:
- 5+ Years of API Manufacturing experience supporting API production operations and/or technology transfer
- 2+ years of demonstrated leadership and/or mentorship experience is strongly desirable
- Ability to externally represent Lilly in a positive, professional and ethical manner
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 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.
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