Associate Director, Project Manager

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Responsibilities

In collaboration with the Technical Lead, this role will ensure successful execution of the individual technology transfers and for ensuring optimized transfer plans in strict collaboration with Project Managers from CMOs, Manufacturing & Quality (M&Q) central functions, Product Development (PR&D) and Regulatory Affairs. The Associate Director, Project Manager - DPEM TS/MS will coordinate Technical Team members for the technical transfer activities of Drug Products to existing and/or new Drug Product External Manufacturing (DPEM) Contract Manufacturers while establishing, deploying, and applying principles of project management.

Key Objectives/Deliverables:

• Provide leadership for the Project Lead Team, coordinating the project managers to provide updates, track actions to closure and take learnings to implement process improvements.
• Create DPEM Project Management tools to visualize timelines, milestone tracking, and help with resource planning.
• Coordinate Technical Teams by providing objective third-party leadership to plan, execute, resolve issues, manage budgets, communicate progress, and drive healthy relationships between the partners and DPEM Leadership.
• Meet with DPEM Lead Team and other key stakeholders to confirm expectations, overall objectives, and scope, and gather and review pertinent project background information to gain a baseline understanding of the project.
• Review project information such as:
  • project success criteria, including goals and target milestone dates.
  • project team members, their roles and responsibilities, the overall team structure, competing priorities, and any identified resource gaps.
  • relevant information about the partner, including their key stakeholders, and expectations for communications and relationship management.
  • required quality documents (e.g., product specifications, batch records, SOPs, QC methods, process validation) in accordance with Lilly Quality Standards and DPEM SOPs.
  • project Management structures, tools, and processes for this project.
  • project planning and execution progress achieved to date.
  • critical activities, resource allocations, risks, and opportunities.
  • key concerns, potential bottlenecks, or operational constraints.
  • immediate needs to ensure the project progresses per expectations and appropriate Critical Quality Attributes are identified.
• Build the Tech Transfer Team with DPEM leaders in all needed functions and meet team members to gain firsthand understanding of project status, team structure, stakeholders, team dynamics, planned activities, expectations, issues, constraints.
• Create a Project Charter in collaboration with Tech Transfer Team to get the appropriate alignment among stakeholders and senior management on key project characteristics.
• Initiate the project by conducting a kick-off meeting to further align team members on objectives, roles and responsibilities, approach, high-level timeline, current status, issues/risks, and other project characteristics.
• Develop an integrated project schedule in collaboration with Tech Transfer Team in order to:
  • accurately capture the activities necessary to successfully transfer the DPs into the Contract Manufacturer's facility, and ultimately manufacture commercial batches.
  • conduct a review of the draft project schedule to define main project milestones, metrics, and gain additional objective confirmation that required activities, durations, and interdependencies are accurately identified and documented.
  • review a draft of the integrated project schedule with the multi-functional team for completeness, accuracy, and optimization options.
  • solicit feedback, make revisions as necessary, and ultimately secure team buy-in.
  • use the completed integrated implementation schedule to reassess resource requirements for completing defined activities, identify internal and external resource gaps, if applicable, and define resolutions to close the gaps.
• Proactively identifies risks to success, characterizes the risks for potential impact and probability, and identifies mitigation and contingency plans.
• Define how project information will be conveyed to and among stakeholders:
  • develop a reporting mechanism (e.g., dashboard) to track and relay progress against the schedule, issues, and risks to senior management.
  • identify organizational communications about the project to promote awareness of the readiness for the imminent change as required.
• Identify additional project management tools and processes to be implemented, as deemed beneficial to maintain alignment and ensure the project progresses on schedule. Examples might include a Roles and Responsibilities Matrix, Issues Log, budget tracker, etc.
• Lead the project team through execution of the comprehensive project plan to complete the technology transfer.
• Apply Technology Transfer project governance gating according to the Single Process Map by scheduling, authoring, and presenting the gates in collaboration with the GPLOT leader and ensure/facilitate technical project governance in collaboration with the Tech Lead.
• Serve as an effective liaison between all stakeholders to ensure requirements and expectations are defined, communicated, and understood.
• Manage the relationship and all communications with CMs, pursuant to defined expectations.
• Work with team members as necessary to resolve any issues or to escalate them to the project team, project sponsor, or steering committee when mandatory.
• Maintain an accurate project schedule. Maintain a comprehensive project file that ensures the availability of the most up-to-date information to all project stakeholders according with Document Control requirements.
• Conduct periodic reviews of the project schedule with the core team to identify any issues any changes in scope, schedule, or budget that may precipitate a new risk or potential risks, and define corresponding issue resolution or risk mitigation plans, as necessary.
• Prepare regularly scheduled progress reports that clearly communicates progress to date versus the plan, key accomplishments, and current issues/risks.
• Communicate issues, risks, and changes to the project team and sponsor, as required.
• Facilitate project-level issue identification, tracking, and resolution while leading the project team's decision-making processes to ensure indecisiveness does not delay progress or minimize success.
• Ensure communication requirements are satisfied.
• Facilitate and monitor the activities of team members to ensure constructive team dynamics, effective communication, and progress in conformance with project scope and schedule.
• Plan, support, and/or facilitate routine and ad-hoc core team and on-site team meetings.
• Prior to meetings, identify the meeting objectives and prepare corresponding agendas.
• Lead discussion-driven meetings, capture meeting outcomes, key decisions, and action items, and ensure appropriate communication to all stakeholders.

Relationships:

• Contract Manufacturing leadership and functions.
• All relevant functions at the Lilly Manufacturing Networks (such as M&Q central functions, Product Development and Regulatory Affairs).
• DPEM and Lilly External Manufacturing teams (API, Indy Device Manufacturing (IDM)).

Basic Qualifications

• Education:
  • Bachelor's Degree or higher in science or science-related field such as Pharmacy, Chemistry, Engineering, Biological science or related Life Sciences.
• Minimum of 8 years of experience in project management and drug product manufacturing (qualification, technical transfers, commercialization of new products, etc.).

Additional Skills/Preferences:

• Demonstrated ability of collaboration to operate cross functionally and hold technical/process discussions with third parties.

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