Project Manager - Clinical Supplies

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Bethlehem, PA

Industry: Pharmaceuticals & Biotech

  •  

Less than 5 years

Posted 12 days ago

  by    Kristine Chimics

The  Project Manager (PM) organizes all activities involved with the management of clinical and commercial supplies.  This includes but is not limited to the following services:  procurement, distribution, formulation/development, manufacturing, packaging and analytical services.  The PM serves as the primary business partner contact.  It is the responsibility of the PM to define the scope and timing of the requested services.  The PM coordinates all internal and external communication relative to each project.

Essential Duties and Responsibilities

  • Comply with cGMP guidelines
  • Serve as the primary liaison for business partners
  • Interview business partner to obtain all relevant project information
  • Interpret protocols and protocol summaries
  • Communicate necessary information to all appropriate departments for the purpose of initiating the quoting process
  • Prepare project timeline with input from key operating departments and business partner
  • Identify components required as per business partner needs  and submits requests for procurement
  • Write Batch Records (BRs) in compliance with cGMPs and SOPs in a timely, accurate and concise manner
  • Review and approve packaging prototypes, as required, for production
  • Document background information for all projects and maintain complete record files
  • Collaborate with key operating departments to meet internal dates for timely completion of requested activities
  • Work with colleagues to resolve potential conflicts with projects
  • Inform management and business partners of project delays and recommend appropriate solutions
  • Adhere to policies, processes and SOPs to ensure compliance with cGMP, FDA and any other regulatory regulations and standards

This position requires:

  • Bachelors' Degree in the sciences and/or related experience
  • 3 - 5 years in experience in Project Management, preferably in pharmaceutical clinical supplies or clinical research/supply environment
  • Demonstrated ability to work independently, handle multiple tasks simultaneously and negotiate and meet critical timelines
  • Excellent oral and written communication is required to communicate with the team, peers, management and external contacts
  • Knowledge of cGMPs, FDA , DEA and OSHA Regulations and ISO guidelines, preferred
  • Basic knowledge of drug product nomenclature and drug development process
  • Strong ability to contribute and function in a team environment to achieve Company goals