Senior Scientist

This position is located in San Diego California. You must be open to relocation to San Diego if you are interested in this role!

If you want to know about the requirements for this role, read on for all the relevant information.

Seeking an experienced analytical chemist to join our AD/QC group at the Sr. Scientist or Assistant Director level. The ideal candidate will be a self-starter, familiar with a broad range of analytical techniques, possess a strong work ethic, have good communication skills, and have experience working in a GMP environment. The successful candidate will be able to perform the following responsibilities with a high degree of independence and attention to detail.

PRIMARY RESPONSIBILITIES:

Coordinate and execute testing of drug substance intermediate, drug substance, and drug product samples

Develop drug substance specifications ensuring efficient integration across Chemistry, Manufacturing, and Controls (CMC) and other relevant disciplines such as Clinical and Toxicology

Author scientific reports and portions of the CMC section of regulatory filings

Manage the analytical activities for oligonucleotide therapeutic development projects

May develop and optimize analytical methods

Design and execute method validation and method transfer protocols

Manage outsourced analytical activities at external contract labs

Conduct analytical investigations

Present at internal and cross-functional scientific meetings

REQUIREMENTS:

BS or MS with at least 5 years (Sr. Research Associate) or 10 years (Assistant Director) of industry experience in Analytical Chemistry or related discipline

Ph.D. with at least 2 years (Sr. Scientist) or 7 years (Assistant Director) of industry experience in Analytical Chemistry or a related discipline

Skilled in operating LC-MS, HPLC, and GC for the analysis of drug substance and drug product samples

Good understanding of the drug development process

Practical knowledge of GMP requirements, with hands-on GMP experience preferred

Good understanding of ICH and FDA method validation guidelines, including phase-appropriate strategies

Ability to problem solve, manage priorities and maintain aggressive timelines for multiple projects

Ability to work productively and independently within a team or matrix environment

Good written and verbal communication skills