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CMC Stability Coordinator

  • Date Posted November 5, 2020
  • Location Boston, Massachusetts
  • Job Type Direct
  • Job ID 16603

CMC Stability Coordinator

Our client, an emerging, publicly traded pharmaceutical company in Boston experiencing rapid growth is currently looking for a CMC Stability Coordinatorto join their team. This person will be responsible for managing contract partners stability oversight of APIs and drug products for all global development programs, from phase I to commercial registration.

Responsibilities

  • Review all stability data /reports and update stability tables accordingly
  • Perform trending analysis of stability data and facilitate timely investigation of OOT & OOS occurrences
  • Compile and write Annual Product Reviews for products, as necessary
  • Support drafting of stability updates for regulatory filings including IND’s and IND annual reports
  • Provide support to coordinate completion of technical reports through contract research organizations (CRO’s) and contract development and manufacturing organizations (CDMO’s)
  • Draft drug substance and drug product specifications and obtain signatures for approval
  • Review and document test methods, batch records, stability protocols, method validation protocols and reports

Required Qualifications

  • Bachelor's degree in a scientific discipline. Master's degree preferred
  • 3 – 5 years pharmaceutical industry experience in Analytical Development, Quality Control or Quality Assurance
  • High proficiency with MS Excel & Word necessary
  • Participation in regulatory agency inspections and experience with document management systems and Slimstat® shelf-life projection software a plus.
  • Previous experience working with pharmaceutical vendors / collaborators highly preferred
  • Excellent written and oral communication skills, with the ability to communicate complex information allowing for an open and effective dialogue throughout the company.
  • Strong organizational skills with the ability to effectively multi-task and prioritize
  • Ability to flexibly adapt to changing business needs and meet timelines
  • Ability to analyze & interpret stability data
  • Strong attention to detail and quality are critical to success
  • Resourceful, self-starter and team player with a strong results orientation
  • Highly motivated, decisive, and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing company.
  • Proven ability to manage multiple projects, identify and resolve issues.
  • Broad experience in a small company environment is a plus

If you are interested in this position, please send your resume to apowell@daleyaa.com