Senior. QC Specialist
Job Summary and Essential Functions:
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