A reputable biotechnology company seeks a Senior Manager, Analytical Development to manage a small team and support the process development and quality testing of medical devices.
Responsibilities:
- Manage team of 2-4 members
- Develop analytical test methods for device products by designing experiments and analyzing studies
- Lead assay transfer to Quality Control department and author protocols and reports
- Enable testing for Extractables and Leachables (E&L) to support process development and quality activities for devices
- Oversee external vendors (CROs)
- Support regulatory submissions by authoring documents related to analytical methods and data
Qualifications:
- PhD with 5+ years in pharmaceutical or medical device industry with related coursework in Materials Science, Biomedical engineering, Polymer or Analytical Chemistry, or a related field. A Masters degree with additional relevant experience will also be considered!
- Experience in developing, validating, and transferring analytical methods using FTIR, chromatography (HPLC, GC, UPLC, LC-MS,...), etc.
- Familiar with ISO and ICH regulations regarded to impurity and E&L testing
Employees are required to be vaccinated against COVID-19 with exemptions for medical, religious, or other accommodations.
