Enlaza Therapeutics
Scientist II, Analytical Development (Biologics Discovery/CMC)
Enlaza Therapeutics, 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. Key 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 is preferred
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 disability 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
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. Key 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 is preferred
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 disability 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