What are the responsibilities and job description for the Manager Analytical Development position at Brightpath Associates LLC?
Job Description
We currently have an exciting opportunity available for a Senior Manager, Analytical Development.
The Senior Manager will support the development of analytical methods.
Qualifications
- The Senior Manager will be responsible to direct the work of analytical development scientists
- Oversees day to day operations of the analytical development team
- Plans for future project including budget and timelines
- Ensures project timelines are met
- Serves as a process and scientific subject matter expert
- Ensures compliance with cGMP process, training, procedures
- Responds to reports from internal/external audits
- Directs validation, development, and qualification studies and reports
Education Requirements:
- Master’s degree or PhD in biochemistry, chemical engineering, biophysics, biology or related discipline.
- Bachelor’s degree and 12 years of process development experience
Experience Requirements:
- 10 years of experience developing protein purification processes.
- 2 years of experience in a GMP environment.
Other Essential Knowledge:
Protein biochemistry, especially immunoglobulin chemistry.
Assay development
Assay validation
GMP method development and validation
Technical transfer of methods
