ASSISTANT DIRECTOR,ANALYTICAL DEVELOPMENT & QUALITY CONTROLSeeking an experienced analytical chemist to join our Analytical Development & Quality Control (ADQC) group at the Assistant Director level. The ideal candidate will be familiar with a broad range of analytical chemistry techniques with an emphasis on mass spectrometry, possess a strong work ethic and strong technical background, demonstrate excellent oral and written 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.
WORK LOCATION: onsite in Carlsbad, CA
RESPONSIBILITIES:
- Manage the analytical activities for oligonucleotide therapeutic development projects
- Coordinate and execute testing of drug substance intermediate, drug substance, and drug product samples for release and stability studies
- Manage outsourced analytical activities at external contract labs
- Conduct analytical investigations
- Develop and optimize analytical methods
- Develop drug substance specifications ensuring efficient integration across Chemistry, Manufacturing, and Controls (CMC) and other relevant disciplines such as Clinical and Toxicology
- Design and execute method validation and method transfer protocols
- Author scientific reports and portions of the CMC section of regulatory filings
- Present at internal and cross-functional scientific meetings
REQUIREMENTS:- A minimum of 8 years for BS or 6 years with a Master's of industry experience in Analytical Chemistry or related discipline
- Ph.D. with a minimum of 3 years 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 solve problems, manage priorities and maintain aggressive timelines for multiple projects
- Ability to work productively and independently within a team or matrix environment
- Excellent written and verbal communication skills
Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition # IONIS004157
Ionis offers an excellent benefits package! Follow this link for more details:
Ionis BenefitsFull Benefits Link: https://ionis.com/careers#:~:text=Highly%20competitive%20benefits
The pay scale for this position is $95,411 to $174,695
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
