Associate Director, CMC Project Manager

Position Summary

The Associate Director, CMC Project Manager (CPM) will manage allocated Contract Manufacturing Organizations (CMOs) that may be local, regional or global in scope. The MPM will be 100% accountable for the success of their projects.

Responsibilities

  • CPM is responsible for the overall coordination and management of CMC from start up through final product delivery. Directs the technical, financial and operational aspects of the projects with the CMOs- thus securing the successful completion of all steps of the manufacturing process.
  • Works with major functional area leads to identify and evaluate fundamental issues on the project, interpret data on complex issues, make good business decisions and ensure solutions are implemented
  • Works to ensure that all project deliverables meet the time/quality/cost expectations
  • The CPM, working in collaboration with the manufacturing, supply chain, quality, quality control and other functional area leads, is accountable for ensuring that all project deliverables meet company expectations

Requirements

  • Lead the CMC project team and facilitate their ability to successfully complete project deliverables
  • Lead cross CMC unit coordination both internal and external, inclusive of sub-contractors
  • Lead through the use of managing the timeline, action items, minutes and budget
  • Integrate CMC plans and timelines with Core Team plans and timelines.
  • Define and manage project resource needs and establish contingency plans for key resources
  • Ensure successful design, implementation, tracking and revision of project plans for assigned projects
  • Promote effective teamwork among project team members
  • Resolve conflicts as needed
  • Ensure appropriate communication on project-related matters with the Manufacturing/PM Management
  • Meet financial performance targets for the assigned CMC projects
  • Ensure project deliverables are met according to established expectations
  • Initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects
  • Act as key contact for assigned projects
  • Establish excellent working relationships with project teams and vendors to ensure satisfaction and operational excellence
  • Ensure that all staff allocated to assigned projects adhere to professional standards and SOPs established for CMC
  • Manage all aspects of designated projects

OTHER SKILLS AND ABILITIES

The CPM possesses a high level of the following skills and attributes:

  • Sound knowledge of the key principles of cross functional project management (time, quality, cost)
  • Solid financial acumen
  • Effective negotiation technique and evidence of organizational, CMC, development and commercial knowledge
  • Displays effective communication skills (listening, oral and written) and can communicate in the English language (oral and written)
  • The ability to persuade, convince, and influence/impress others
  • Organizational skills and proficiency at multi-tasking with excellent attention to detail
  • Demonstrated ability to lead, motivate and coordinate teams and coach/mentor team members as appropriate
  • The ability to delegate effectively and prioritize own and workload of project team members
  • Cross cultural awareness and ability to adapt appropriately
  • Ability to work independently
  • Strong computer skills

REQUIREMENTS

  • University/college degree (life science preferred) or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology) or equivalent combination of education and experience that provides the individual with the required knowledge, skills and abilities
  • Minimum of seven (7) years of clinical pharmaceutical / biotechnology industry experience including demonstrated skills and competency in manufacturing project management tasks
  • In lieu of the above requirements, candidates with > five (5) years supervisory experience in a health care setting and six (6) years clinical research experience in the pharmaceutical or CRO industries will be considered
  • Thorough knowledge of project management processes
  • Can demonstrate experience of successfully managing and/or leading multidisciplinary project teams
  • Experience using project management software
  • Thorough knowledge of ICH Guidelines and GCP/GMP including international regulatory requirements
  • Solid understanding of how to craft and manage a project plan and budget
  • Available for domestic and international travel, including overnight stays
  • Valid current passport required
  • Ability to drive and have a valid driver’s license
  • Fluent in local office language and in English, both written and verbal
  • Broad knowledge of drug development, CMC and client needs