Feel free to contact us.

Director, CMC Project Management

Department: Operations

Job Title: Director, CMC Project Management

Reports To: Michael Krautkramer

Description:

This position will occupy a key role partnering with Chemistry, Manufacturing and Controls (CMC) teams to provide operations support and planning to ensure that resources are deployed efficiently and projects are completed on time and within budget. This position will work primarily within CMC but also support the nodes where CMC interfaces with other functional groups within Avid. This position is also responsible for working with Avid’s Chemical Development and Manufacturing senior leadership team to implement corporate goals and objectives for manufacturing teams.

Key Responsibilities:

  • Assist with the development of the long term strategic plan for development and manufacturing teams
  • Lead CMC teams in establishing clear scope of work and drive team towards the delivery of project milestones on time, on budget, and within scope through utilization of project management tools
  • Identify the project objectives and scope, develop and implement project strategy, and identify measurable success criteria for CMC projects, in collaboration with the Project Sponsor and Technical/Scientific Lead
  • Provide leadership and direction to Technical/Scientific project leads
  • Develop project documentation standards (e.g. project charter, project reports, etc.)
  • Facilitate communication across company and engage stakeholders with a solution oriented focus and present strategies and plans to senior leadership
  • Prepares and conducts project team meetings including issuing of agenda, action items, and meeting minutes
  • Work with CMC senior leadership to create project schedules that are integrated across all functions and aligned with company objectives prioritization
  • Partner with Clinical Development teams to align CMC with Clinical Development, Quality and Discovery efforts into integrated project plans ensuring cross functional alignment and accountability from project initiation through completion
  • Identify and monitor critical path, utilizing Project Management tools and develop contingency plans when the project deviates from that path
  • Identify gaps in existing processes and drive the implementation of solutions that increase productivity and efficiency of the organization
  • Understand the commercial and customer needs of the project and integrate the learning to development of planning
  • Assist with the management of the Chemical Development and Manufacturing budget by maintaining actuals to plan by working with Manufacturing Directors and Avid Finance
  • Manage laboratory expansion projects for Avid laboratories and facilities as needed
  • Support CMC and clinical project planning for regulatory filings worldwide
  • Ensure formal project closure (best practice identification, lessons learned, documentation)
  • Build and maintain effective teams: motivate, recognize, coach and mentor team members
  • Coordinate internal and Avid-Lilly meetings, and document and communicate key takeaways to relevant constituents
  • Foster a team culture of ownership and accountability including continuous evaluation, recognition and process improvement

Requirements:

Basic Qualifications:

  • Bachelor of Science (degree in Chemistry, Chemical Engineering, or Mechanical Engineering preferred)
  • 5+ years of project management experience
  • 2+ years of experience within a CMC department or group with hands on experience in chemical drug development
  • Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position

Additional Skills/Preferences:

  • Demonstrated project management experience with a complex manufacturing development processes
  • Experience in radiopharmaceuticals a plus
  • Excellent computer skills (e.g., MSExcel, MSProject)
  • Superior written and verbal communication skills
  • Strong organizational skills and attention to detail
  • Strong interpersonal skills particularly motivational, negotiation, listening, judgement, analytic and conflict management skills, demonstrated by ability to effectively interface across all levels of the organization
  • Demonstrated people management skills. Ability to create effective relationships, motivate others, influence without authority, and collaborate internally and externally at all organization levels
  • Ability to collaborate and influence team members and leaders across the company as well as to be able to work in a rapidly changing environment
  • Ability to work both independently and in a team focused environment
  • Strong ability to embrace ambiguity and manage complexity and demonstrate problem-solving leadership
  • Ability to translate complex concepts into actionable, measurable tasks
  • Operating skills including the ability to plan and organize the work to marshal resources and get the work done
  • High level of personal and professional integrity and trustworthiness with strong work ethic

Additional Information:

  • Some travel required (less than 20%)
  • Lilly is an EEO/Affirmative Action Employer and 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


Apply for this position: Click here

 

Return to Open Positions