Project Manager, API for CDMO

Location
Ewing, New Jersey
Salary
401K, Medical Insurance, Dental Insurance, Vision Insurance
Posted
Jul 19, 2021
Closes
Sep 17, 2021
Field of specialization
Pharmaceutical
Work Function
Administration
Job Type
Full time

Job Summary

Plan, organize, and lead the time-critical project planning process in TCG GreenChem, Inc. for projects from Lead Optimization, Candidate Selection and IND enabling Preclinical Toxicity studies, to Phase I clinical supplies for API.  Establish and maintain systems and business processes to track and report internal defined project objectives coupled with milestones for the TCG GreenChem portfolio consisting of US clients and international clients. Utilize these systems and business processes to routinely report time critical project planning activities for manufacture of API in a globally harmonized fashion in alliance with TCG Lifesciences in India in support of project-specific strategic decision making.  Manage a business process platform to evaluate project planning scenarios, including milestone and deliverable dates, decision points and optimal balance of risks to meet short- and long-term development objectives across multiple projects.

Principal Duties

  1. Establish and manage business processes to plan, track, and effectively manage time-critical development activities including milestones and deliverables for projects from Lead Optimization, Candidate Selection and IND enabling Preclinical Toxicity studies, to Phase I clinical supplies for API
  2. Identify and implement globally harmonized project planning tools and systems to ensure efficient, consistent planning for current and long-range planning in order to meet clients’ projects/requests
  3. Identify and implement globally harmonized project planning tools and systems to ensure efficient, including impact of new projects on current client projects
  4. Consolidate project priority and scheduling information between TCG GreenChem R&D teams and TCG Lifesciences for specific FTEs and Fee For Service (FFS) jobs.
  5. Provide the platform for critical path analysis, options, and recommendations for elimination of critical bottlenecks
  6. Provide interface for project planning and resource management for TCG GreenChem in concert with TCG Lifesciences manufacturing facilities
  7. Manage and ensure consistent application of tools across all project teams
  8. Increase expertise in project management

Job Qualifications

  • Ph.D. or Master’s Degree with 5+ years of pharmaceutical industry experience or equivalent
  • Broad knowledge of critical-path project management concepts and project planning applications
  • Broad knowledge of pharmaceutical development processes and multifunctional interfaces
  • Effective communication, interpersonal, and teamwork skills
  • Knowledge of TCG GreenChem business and global development departments (i.e., organizational structure and function)
  • Knowledge of software applications for business and project management

Skills Required

  • Excellent verbal and written communication
  • Critical thinking
  • Problem solving
  • Active listening
  • Out-of-the-box thinking
  • Proactivity
  • Knowledge of regulatory requirements

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