Assistant Director, Analytical Development & Quality Control (Biotech)

Location: Onsite in Carlsbad, California, United States

Salary: $95,411–$174,695 annually

Company

Develops RNA-targeted medicines and gene-editing approaches for serious diseases, with a focus on neurology, cardiology, and other areas of high unmet medical need.

What you will do

• Manage analytical activities for oligonucleotide therapeutic development projects.
• Coordinate and execute testing of drug substance intermediates, drug substances, and drug products for release and stability studies.
• Manage outsourced analytical work at external contract laboratories.
• Conduct analytical investigations and develop or optimize analytical methods.
• Develop drug substance specifications and integrate analytical requirements across CMC, Clinical, and Toxicology functions.
• Design and execute method validation and method transfer protocols, author scientific and regulatory CMC documentation, and present findings at scientific meetings.

Requirements

• At least 8 years of industry experience with a bachelor's degree, 6 years with a master's degree, or 3 years with a Ph.D. in Analytical Chemistry or a related discipline.
• Hands-on experience operating LC-MS, HPLC, and GC for drug substance and drug product analysis.
• Understanding of the drug development process, GMP requirements, and ICH and FDA method validation guidelines.
• Ability to solve problems, manage priorities, and maintain aggressive timelines across multiple projects.
• Ability to work independently and productively in team or matrix environments.
• Excellent written and verbal communication skills.

Culture & Benefits

• Onsite work environment focused on innovation and scientific excellence.
• Opportunities to contribute to medicines for patients with serious diseases and unmet needs.
• Excellent employee benefits package.
• Collaboration across internal and cross-functional scientific teams.