Associate Director, Biologics Analytics

Xaira Therapeutics; South San Francisco (CA); On-site; USD 172,000 - 215,000; Full time

Benefits offered by this job

Competitive compensation

Equity options

Bonus structure

Job summary

Xaira Therapeutics in South San Francisco is looking for an Associate Director in Analytical Development (Biologics) to lead and oversee analytical strategies for biologics programs through clinical execution. You will be responsible for method development, validation, and regulatory submissions in a fast-paced environment.

The ideal candidate should have a PhD with extensive experience in analytical chemistry, strong knowledge of biologics CMC development, and hands-on experience with techniques such as HPLC and LC-MS. The position offers a competitive salary along with a flexible work environment.

Qualifications

• PhD in analytical chemistry or related discipline with more than 8 years of industry experience.
• Demonstrated experience in analytical development and method validation within a regulated environment.
• Strong knowledge of biologics CMC development and cGMP expectations.

Responsibilities

• Lead the development and validation of analytical methods for biologics programs.
• Manage analytical activities performed by external contract laboratories.
• Author and review relevant CMC sections for regulatory submissions.

Skills

Analytical development

Regulatory submission experience

HPLC, UHPLC, LC-MS

Project management

Education

PhD in analytical chemistry or related discipline

BS/MS degree with significant experience

Tools

HPLC

LC-MS

SEC Chromatography

RP Chromatography

IEX Chromatography

Job description

Xaira Therapeutics in South San Francisco is looking for an Associate Director in Analytical Development (Biologics) to lead and oversee analytical strategies for biologics programs through clinical execution. You will be responsible for method development, validation, and regulatory submissions in a fast-paced environment.

The ideal candidate should have a PhD with extensive experience in analytical chemistry, strong knowledge of biologics CMC development, and hands-on experience with techniques such as HPLC and LC-MS. The position offers a competitive salary along with a flexible work environment.