Associate Director – Joint Process Team Leader DPEM

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Organization Overview:

Drug Product External Manufacturing (DPEM) is responsible for making medicine at contract manufacturers located globally, selected by Lilly to make drug product that will bear the Lilly brand. DPEM manages technical, quality, supply and financial aspects with the contract manufacturers and alliances who supply product to Lilly to ensure risks to Lilly in manufacturing product outside Lilly is appropriate and provides optimum protection to the Lilly brand.

Location: Sesto Fiorentino (FI) with frequent visit at CM (central Italy region mainly, others OUS)

Responsibilities:

JPT Leader role is the externally facing business owner for the relationship between Lilly and a contract manufacturer (CM). They report to the Senior Director of Operations OUS and serve as a link between the JPT and the DPEM Lead Team as a core member of the Flow Team.

The Joint Process Team Leader (JPTL) is the externally facing business owner for the relationship between Lilly and a contract manufacturer and provides leadership to the cross-functional Joint Process Team (JPT). This JPTL role will provide leadership for OUS based contract manufacturer relationships.

• Support On-Going CM Operations by providing leadership and oversight at the Join Process Team
• Leads cross-functional JPT, between Lilly and CM, to develop and implement strategically aligned Quality and Supply Plans and the Technical Agenda for the CM.
• Accountable for the governance process over the CM and the monitoring of business, quality, safety and technical metrics, identifying areas of concern or risk, generating CAPA’s and improvement plans and timely escalation of issues.
• The Joint Process Team Leader ensures that the process team is operating as an effective, well-balanced team and can make appropriate science-based decisions.
• The Joint Process Team Leader acts as an integrator and has accountability of all aspects of joint process team results which includes:
• Establish operational plan for the CM
• Key contact for escalations from CM leadership team to Lilly
• Assist with all issues related to the CMOs manufacturing process including but not limited to Quality, HSE events, facilities, equipment, training, trend analysis and self-monitoring
• Recognize when issues are beyond the technical capabilities of the JPT and when to request additional technical assistance
• Escalating issues to the appropriate management level when necessary, following the appropriate notification to management process
• Owning the change and OpEx improvement agenda of the JPT
• Manage production, batch release, cycle time, WIP and shipment schedules to ensure appropriate resources are available to meet objectives.
• Frequent visit at CMs site
• Assuring that the process team understands the process economics and how the decisions impact the plant financial scorecard.
• The Joint Process Team Leader could be responsible for more than one joint process team CM relationship.
• Has awareness of contract requirements. Ensures that the MRD is in place and relevant aspects of the contracts are being adhered to by Lilly and the CM.
• The Joint Process Team Leader is aware of procurement and compliance regulations.
• The Joint Process Team Leader knows the Operational Control Strategy for CMs processes.
• Ensuring that the JPT is conducting Root cause Analysis and Failure Mode and effect Analysis (FMEA) with the CMs.
• The Joint Process Team Leader acts consistently with the Lilly values and the Team Lilly expectations and serve as positive role model for their Process Team and the organization
• The Joint Process Team Leader leads the internal Operational Process review (iOPS) with the DPEM Lead Team according to the annual calendar.
• Relationship with Contract Manufacturer (CM)
• Make regular visits to CM to increase awareness of operations and maintaining strong working relationship.
• Manage conflict and problem resolution.
• Facilitate Lilly/CM Steering Team with issues from the JPT requiring Steering Team actions.
• Participate to the Executive Steering Committee meetings with CMs and Senior Lilly leadership team
• Support internal and external audits performed at the CM related to the Lilly product portfolio

Basic Requirements:

• Bachelors Degree required (engineering, pharmaceutical chemistry and technology,..)
• Minimum 10 years+ of experience supporting pharmaceutical manufacturing

Additional Skills/Preferences:

• cGMP Operations leadership experience in parenteral environment (i.e. syringes)
• Experience in implementing OpEX roadmap
• Experience in Statistical Process Control (SPC) and Six Sigma Tools (e.g. Green Belt certification) or Lean Tools
• Strong leadership, strategic thinking, interpersonal and teamwork skills, able to work effectively in a team environment
• Strong influencing and negotiation skills
• Capability to work in a virtual and complex environment across different cultures
• A thorough understanding of cGMPs regulations
• Experience with combination products and tech transfer
• Business and financial acumen
• Ability to communicate at executive level

Additional Information:

• Travel up to 30%
• Day Shift

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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