Collins McNicholas

Senior. QC Specialist

Job Summary and Essential Functions: 

Summary: 

 

Perform assay development, characterization, optimization, transfer, validation and investigation for QC chemistry group.  Provide technical support, guidance and supervision for release, stability, and in-process testing and assay development.

 

Essential Duties and Responsibilities include, but are not limited to, the following:

 

  • Performs assay development/validation for QC Chemistry or Biochemistry groups.
  • Reviews new test procedures and assays.
  • Evaluates and bring in new methodologies/techniques when needed
  • Facilitate assay transfer from R&D and to business partners.
  • Organize analytical assay transfer internally and externally
  • Lead technical troubleshooting and problem investigation.
  • Review analytical development report, assay and process validation report and other technical documents for technical correctness and regulatory compliance.
  • Participates in training programs for analysts.
  • Represent QC in project teams and provide Quality input across functional areas
  • Oversee Contract Laboratory testing
  • Position requires strong technical skills in combination with strong communication skills in order to meet QC objectives
  • Requires approximately 30 to 40% of direct time in the laboratory
  • Write and review CMC sections for regulatory submissions

 

Experience and Required Skills: Education and Experience:

  • Requires Bachelor’s degree in Biochemistry, Chemistry, Biology or related field with 15+ years of  relevant experience or advanced scientific degree such as a MS with 10+ years of relevant experience

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