Available Positions

CMC Stability Coordinator at Biopharmaceutical Company in Boston, Massachusetts, United States —

  • bio Pharmaceutical
  • Biopharmaceutical Company
  • Boston, Massachusetts, United States
  • 1/19/21

Job ID: 1361367

Job Description

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 

Qualifications

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
  • Able to command respect from peers and capable of highly independent work as well as being a team player and role model.
  • 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

 

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