Scientist II, Analytical Development (Biologics Discovery/CMC)

Enlaza Therapeutics·
San Diego, CA
2w ago
Full-timeMidAnalytical DevelopmentBiologicsBiologicsMasters
$130K - $150K/yr

Description

We are seeking a highly motivated and skilled analytical development scientist to join our team at our site in San Diego. The successful candidate will leverage their expertise in a range of analytical techniques to support the characterization and development of protein- and antibody-based therapeutics in Enlaza’s covalent biologics platform. The scientist will be responsible for hands-on work to develop, optimize, and execute analytical methods for deployment to support discovery and pre-clinical research through early-stage manufacturing development. They will also provide technical support of analytical development and method transfer and qualification/validation, review of DS/DP release and stability data, and contribute to analytical content in regulatory communications. Key Responsibilities include: 1) Independently design, develop, and optimize analytical methods for release, stability, and characterization of biologics. 2) Perform routine physicochemical analytical testing to support biologics drug discovery research and early-stage process development. 3) Analyze and interpret complex analytical data. 4) Maintain detailed and accurate records in electronic laboratory notebooks. 5) Propose continuous improvement in analytical sciences. 6) Represent the analytical development function in cross-functional CMC and research project teams. 7) Contribute to oversight of external analytical development activities.

Requirements

Advanced degree in analytical chemistry, biochemistry, or closely related field, with 3+ years of industry experience in analytical development for protein-based biopharmaceutical products. Subject-matter expertise in analytical separation sciences and proven track record of successful method development and validation. Demonstrated skill in hands-on operation of modern analytical instruments. Strong understanding of protein chemistry and degradation pathways. Excellent written communication skills and previous exposure to authoring regulatory submission content are preferred.
Enlaza Therapeutics

Enlaza Therapeutics

BIOTECHNOLOGY

Covalent Biologics

LocationCA - La Jolla
Open Jobs2
Biologics
View Company Profile