Job Title: SRA/Assistant Director, Analytical & QC
Job Number: 33204
Location: , CA
- Oversee the analytical tasks involved in developing oligonucleotide therapeutics, including coordinating and conducting tests on drug substances and products.
- Develop and execute protocols for validating and transferring methods, manage outsourced analytical work at external labs, and create specifications for drug substances that align with other areas of the drug development process.
- Write scientific reports and contribute to the CMC section of regulatory filings. Investigate analytical issues and present findings at internal and cross-functional meetings.
- Candidates for this position should hold a BS or MS degree and have at least 5 years of industry experience, or a Ph.D. degree and at least 2 years of industry experience in Analytical Chemistry or a related field.
- Candidates should have experience using LC-MS, HPLC, and GC to analyze drug substance and drug product samples, and possess a solid understanding of the drug development process.
- Practical knowledge of GMP requirements is necessary, and hands-on GMP experience would be preferred.
- Familiarity with ICH and FDA method validation guidelines, including phase-appropriate strategies, is also important.
- Candidates should be able to problem-solve, manage priorities, and maintain aggressive timelines for multiple projects.
- Work productively and independently within a team or matrix environment, and possess excellent written and verbal communication skills.
Compensation and Benefits:
Salary range: $92,000 to $126,000/year
Health Insurance (medical, dental, vision)
Short- and Long-Term Disability
Paid Time Off (PTO) – 3 weeks PTO and 16 Paid Holidays