ZipRecruiter
Scientist II, Analytical Development (Biologics Discovery/CMC)
ZipRecruiter, San Diego, California, United States, 92189
About Enlaza Therapeutics
Enlaza Therapeutics is a biotech company developing an innovative synthetic biology platform to create a disruptive new class of biologic therapeutics. We are dedicated to the development of these novel therapies to help patients suffering from cancer and other serious diseases. Role 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. 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 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 (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 Previous experience with analytical support of process development, formulation, or drug product groups Compensation
In addition to a competitive compensation package with stock options, the company also offers a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental insurance. Job Type
Full-time Annual Salary
$130,000-150,000 Supplemental Pay Types
Bonus pay Benefits
401(k) Dental insurance Employee assistance program Flexible schedule Flexible spending account Health insurance Life insurance Paid time off Parental leave Relocation assistance Retirement plan Vision insurance Year-end shutdown
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Enlaza Therapeutics is a biotech company developing an innovative synthetic biology platform to create a disruptive new class of biologic therapeutics. We are dedicated to the development of these novel therapies to help patients suffering from cancer and other serious diseases. Role 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. 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 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 (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 Previous experience with analytical support of process development, formulation, or drug product groups Compensation
In addition to a competitive compensation package with stock options, the company also offers a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental insurance. Job Type
Full-time Annual Salary
$130,000-150,000 Supplemental Pay Types
Bonus pay Benefits
401(k) Dental insurance Employee assistance program Flexible schedule Flexible spending account Health insurance Life insurance Paid time off Parental leave Relocation assistance Retirement plan Vision insurance Year-end shutdown
#J-18808-Ljbffr