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Enlaza Therapeutics · 3 weeks ago

Scientist II, Analytical Development (Biologics Discovery/CMC)

San Diego, CA

Full-time

Onsite

Mid Level

$130K/yr - $150K/yr

3+ years exp

Enlaza Therapeutics is a biotech company developing an innovative synthetic biology platform to create a disruptive new class of biologic therapeutics. The company is seeking a highly motivated analytical development scientist to support the characterization and development of protein- and antibody-based therapeutics, focusing on method development, optimization, and execution for pre-clinical research and early-stage manufacturing.

BiopharmaBiotechnologyHealth CareTherapeutics

Responsibilities

Independently design, develop, and optimize analytical methods for release, stability, and characterization of biologics, such as antibodies, ADCs, and bispecifics

Perform routine physicochemical analytical testing to support biologics drug discovery research and early-stage process development, including HPLC (SEC, HIC, IEX), CE (icIEF, CE-SDS), physical testing (UV-Vis, pH, osmolality), and impurities (HCP)

Analyze and interpret complex analytical data, identifying trends and correlations to inform project decisions and support process development

Maintain detailed and accurate records in electronic laboratory notebooks, and author and review technical documents including protocols, reports, and method procedures

Propose continuous improvement in analytical sciences in alignment with industry advances and trends

Represent the analytical development function in cross-functional CMC and research project teams

Contribute to oversight of external analytical development activities, including method development, analytical life cycle management, and stability programs

Qualification

Analytical method developmentProtein chemistryAnalytical separation sciencesHPLC operationRegulatory submission contentCross-training opportunitiesWritten communicationTeam collaboration

Required

Advanced degree in analytical chemistry, biochemistry, or closely related field, with 3+ years of industry experience in analytical development for protein-based biopharmaceutical products (equivalent combined education and experience will be considered for the role)

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

Comfort operating on a small, dynamic team and open to providing and receiving cross-training opportunities

Excellent written communication skills

Previous exposure or participation in authoring regulatory submission content

Understanding of early-stage biopharmaceutical development manufacturing unit operations, manufacturing science and technology, and GxP quality control