Scientist II/Sr. Scientist, Analytical Development (Biologics Discovery/CMC)
Job Description
About Enlaza Therapeutics
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Enlaza Therapeutics is a biotech company developing an innovative synthetic biology platform to create a new and unique class of biological medicines. We are dedicated to the development of therapeutics for serious disease and delivering these to patients. We seek an Associate Scientist or Scientist skilled in protein science and protein characterization to help build the foundation of our team and enable our drug discovery efforts.
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Role Description:
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We are seeking a highly motivated and technically skilled Analytical Development Scientist to join our team at Enlaza’s San Diego site. The successful candidate will bring expertise in analytical method development and advanced characterization of protein- and antibody-based therapeutics to support Enlaza’s covalent biologics platform.
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This individual will play a key role in developing, optimizing, and executing analytical methods to characterize antibodies, antibody-drug conjugates (ADCs), and other complex biologics. The role requires hands-on expertise in separation sciences, mass spectrometry-based protein characterization, and biophysical analytical techniques to support drug discovery, lead sequence nomination, preclinical development, and early-stage manufacturing process development.
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The successful candidate will apply orthogonal analytical approaches to evaluate molecular identity, purity, heterogeneity, stability, and quality attributes. They will also contribute to stability study design, analytical strategy development, and cross-functional efforts to advance promising candidates through early-stage development.
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Key Responsibilities:
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- Independently design, develop, optimize, troubleshoot, and qualify fit-for-purpose analytical methods for characterization of biologics, including antibodies, ADCs, bispecific antibodies, and other engineered protein therapeutics.
- Design or perform LC-MS-based characterization, including intact and reduced mass analysis, subunit analysis, peptide mapping, post-translational modification (PTM) assessment, sequence confirmation, and characterization of molecular heterogeneity. Apply appropriate mass spectrometry approaches to investigate structural modifications and support candidate selection and process development.
- Develop and execute chromatographic and electrophoretic methods, including HPLC/UPLC-based size-exclusion chromatography (SEC), hydrophobic interaction chromatography (HIC), ion-exchange chromatography (IEX), and capillary electrophoresis techniques such as icIEF and CE-SDS.
- Apply biophysical and physicochemical techniques to assess protein conformation and colloidal stability aggregation, and other relevant physical properties. Techniques may include UV-Vis spectroscopy, pH, osmolality, dynamic light scattering (DLS), differential scanning fluorimetry (DSF), differential scanning calorimetry (DSC), and other higher-order structure characterization methods, as appropriate.
- Design, execute, and interpret stability studies to evaluate potential critical quality attributes, degradation pathways, and product heterogeneity. Generate analytical data to support lead sequence nomination, candidate selection, formulation development, and early-stage process development.
- Analyze and interpret complex analytical datasets, identify trends and correlations, troubleshoot unexpected results, and communicate scientific conclusions that inform discovery, development, and CMC decisions.
- Maintain accurate and complete records in electronic laboratory notebooks. Author and review protocols, methods and reports, and other scientific documentation in accordance with internal quality standards.
- Evaluate emerging analytical technologies and industry advances, identify opportunities to improve analytical workflows, and implement fit-for-purpose methods to address evolving characterization needs.
- Represent analytical development in cross-functional research and Chemistry, Manufacturing, and Controls (CMC) teams. Partner with discovery, protein engineering, process development, formulation, and other functions to establish analytical strategies and resolve technical challenges.
- For candidates at the Senior Scientist level, lead complex analytical development initiatives, provide scientific guidance on analytical strategy, mentor junior team members, and drive resolution of challenging protein characterization and method development problems.
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Requirements:
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- Advanced degree (Ph.D. or MS) in analytical chemistry, biochemistry, or closely related field, with 4+ 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, biophysical methods, protein characterization and proven track record of successful method development and validation
- Demonstrated mastery in hands-on operation of modern analytical instruments.
- Experience with biophysical and physicochemical characterization techniques to evaluate protein stability, aggregation, conformation, and molecular integrity.
- Strong understanding of biologics heterogeneity, degradation pathways, and analytical approaches for assessing product quality attributes.
- Experience designing and performing stability and forced degradation studies.
- Demonstrated ability to independently plan experiments, troubleshoot analytical methods, interpret complex results, and communicate scientific findings effectively.
- Strong communication skills, attention to detail, and the ability to manage multiple priorities in a fast-paced, collaborative research environment.
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Preferred Qualifications:
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- Experience with advanced mass spectrometry techniques for protein structural characterization, disulfide bond analysis, PTM mapping, and molecular heterogeneity assessment.
- Experience with small format antibody therapeutics.
- Experience as an analytical lead on a cross-functional project.
- Familiarity with analytical method qualification, transfer, lifecycle management, and regulatory expectations for biologics development.
- Exposure to managing outsourced analytical testing or analytical development.
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Compensation:
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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.
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Job Type:
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Full-time
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Annual Salary:
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$120,000 – 184,000
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Supplemental Pay Types:
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Annual Bonus – 10-15%
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Equity
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Benefits:
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- 401(k)
- Dental insurance
- Employee assistance program
- Flexible schedule
- Flexible spending account
- Flexible vacation
- Health insurance
- Life insurance
- Parental leave
- Paid holidays
- Relocation assistance (if eligible)
- Retirement plan
- Vision insurance
- Year-end shutdown
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Enlaza Therapeutics is an equal opportunity employer committed to scientific excellence, innovation, and improving the lives of patients through transformative medicines.