APIEM Associate Director – Joint Process Team

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.

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 will be based in Hyderabad, India and reports into the Ex. Director - External API Manufacturing Operations (who is also located at our Kinsale, Ireland site). The Associate Director, JPT is the key business relationship owner of the 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 pipeline and will be a member of the API EM Flow Team. The Associate Director, JPT will along with other Lilly process team members, oversee Lilly’s India-based contract manufacturers, with particular emphasis on ensuring Lilly’s expected standards of safety, quality and operational excellence are maintained while delivering on supply commitments.

Key Responsibilities

• Lead cross-functional Joint Process Team (JPT), between Lilly and contract manufacturer (CM), to develop and implement strategically aligned Quality and Supply Plans as well as the Technical Agenda for the CM.
• Successfully facilitate and champion quality, technical, and regulatory compliance to ensure continuous supply to the marketplace.
• Manage technology transfer, production, batch release and shipment schedules to ensure appropriate resources to meet objectives.
• Resolve supply chain issues and provide internal notification to management or joint Lilly/CM Steering Team as necessary.
• Accountable for the metrics that align with Manufacturing Standards of Excellence for External Manufacturing and API EM procedures to monitor performance at the CMs, and to review these at API external manufacturing Flow Team and Site Lead Team meetings.
• Serve as liaison to communicate status and issues to various management levels in operations, quality, manufacturing and business unit networks.
• Ensure Lilly and CM is roles and responsibilities associated with the contract (Master Supply Agreements, Work Orders, etc) and Quality Agreement are clearly understood by both parties. Ensure that the contract and Quality Agreement are being adhered to by Lilly and the CM.
• Make regular visits to CM to increase awareness of operations and maintain a strong working relationship. Manage conflict and problem resolution. Facilitate Lilly/CM Steering Team and other governance meeting agendas with issues from the JPT meetings requiring Steering Team action. Present and document the decisions in Steering Team minutes.
• Meet regularly with customers (Lilly plant sites or Lilly affiliates) to ensure supply goals are met, review performance metrics and improve customer service.
• Evaluate and manage efficiencies with product supply chains. Work with TS/MS / QA Representatives and CI on continuous improvement projects.
• Accountable for on time delivery of commitments to supply plan, quality plan, commercialization and technical agenda.
• Deliver all product / projects to comply with GQS, MSOEs, and applicable internal SOP’s.
• Other tasks may include assisting Tech Service, QA, QC and Engineering personnel to ensure timely completion of APR, AR, MR and other deliverables as necessary.
  
  
  

Educational Requirements

• Bachelors and Masters-level Degrees in Engineering or Science disciplines
  
  
  

Requirements

• Bachelors and Masters Degrees in Engineering or Science disciplines
• 8+ years experience in active pharmaceutical ingredient (API) manufacturing functions with large multi-national pharmaceutical firms or large multi-national contract manufacturing organizations. Functions include; operations / production, technical support, process engineering quality assurance, and/or quality control.
• 3+ years experience in leadership roles in an API manufacturing setting with large multi-national pharmaceutical firms or large multi-national contract manufacturing organizations
• Demonstrated experience in delivery of major tech transfer, commercialization or major improvement projects in an API manufacturing setting
• Demonstrated ability to lead teams to produce quality deliverables within established time frames.
• Strong leadership and interpersonal skills, ability to build effective relationships, influence and achieve results through people.
• Self-motivated with ability to react quickly to changing requirements, processes and resourcing levels
• Formal project management skills including proficiency in Microsoft Project
• Demonstrated experience leading cGMP compliant production operations.
• Ability to represent Eli Lilly and Company in a positive, professional, and ethical manner to both internal customers and third party contract manufacturers.
• Proficiency in Word/Excel/PowerPoint and typical pharmaceutical GMP IT systems (i.e., Trackwise, SAP)
• Experience with contracts and relationships with third party suppliers
  
  
  

Other Information

• Travel will be required (~ 20%)
  
  
  

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