Senior Research Scientist

Job Description

This role involves coordinating and executing testing of drug substance intermediate, drug substance, and drug product samples. It requires developing drug substance specifications that efficiently integrate across Chemistry, Manufacturing, and Controls (CMC) and other relevant disciplines such as Clinical and Toxicology. The position also includes authoring scientific reports and contributing to the CMC section of regulatory filings.

Responsibilities

• Manage the analytical activities for oligonucleotide therapeutic development projects.
• 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 findings at internal and cross-functional scientific meetings.

Essential Skills

• Proficiency in Chemistry and GMP.
• Experience in analytical development, particularly in late-stage manufacturing in drug development.
• Strong analytical testing capabilities.
• Knowledge around small molecule and/or biologics expertise, with oligonucleotide experience preferred.
• 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.

Work Environment

The work environment is based in a manufacturing setting where even experienced level employees are expected to perform lab tasks. This role demands a go-getter attitude, as nothing is beneath them, and requires a team player mindset. The position offers flexible work hours or remote work opportunities when works allows for them.