Associate Director/Director, Analytical Development & QC
Location: On-site or Fully Remote.
Salary: 170,000$ - 220,000$ annually
Discipline: Research & Development
Details:
- Offices in San Francisco and North Carolina. The position has also been made available as fully remote for the right candidate.
Responsibilities:
- Responsible for reports and regulatory documents to submit to the FDA.
- Incorporate and regulate systems for the QC team in line with international GMP qualifications.
- Manage CDMOs for Analytical and QC needs.
- Act as a scientific and technical point of expertise when trouble-shooting regular challenges.
Qualifications:
- Bachelor of Science or higher degree.
- Ph.D with 5+ years, M.S. with 8+ years, B.S. with 12+ years.
- Extensive experience with late stage biologics.
- Management of Analytical and QC qualities CDMOs.
- Experience with IND and BLA regulatory filings.
