Associate Scientist/Scientist/Sr. Scientist, Bioanalysis

About Enlaza Therapeutics

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 these novel therapies to help patients suffering from cancer and other serious diseases.

Role Description

We seek an experienced laboratory scientist skilled in bioanalysis of large molecule therapeutics to help enable our drug discovery efforts.
This will be a key role supporting discovery to early-stage biopharmaceutical development. As part of the bioanalytical group, you will analyze samples and develop PK and ADA assays. The ideal candidate is skilled in performing and designing plate-based assay and has excellent documentation and communication skills. The role requires effective time management and the ability to collaborate with colleagues from a variety of technical backgrounds, including pharmacology and drug discovery.

Responsibilities

• Independently perform analysis of in vivo study samples with pharmacokinetic and immunogenicity assays to support discovery pharmacology
• Promptly document, summarize, and report results. Implement and independently manage routine procedures for commonly performed laboratory tasks
• Support method development, optimization, and internal qualification experiments in Bioanalytical group
• Assist with method transfer and project planning as needed

The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.

Qualifications

Required Skills and Experience:

• Bachelor’s or higher degree in biotechnology or life sciences and 5 to 10 years of laboratory-based experience in bioanalysis
• Experience developing and performing quantitative plate-based immunoassays (ELISA, MSD) for PK and/or immunogenicity analysis (ADA, Nab), and biomarkers in a pharmaceutical product setting is required
• Experience with multi-mode plate readers and control/analysis software (e.g. SoftMax Pro, GraphPad Prism)
• Experience performing above assays for Antibodies, Antibody-Drug Conjugates, or other biologics
• Experience with protein and antibody reagent labeling and conjugation methods (biotin, fluorescent labels, SulfoSophisticated understanding of antibody structure and function
• Familiarity with regulatory guidance documents for bioanalytical method design
• Excellent basic laboratory skills: buffer preparation (pH meter, analytical balance, dialysis), protein concentration methods (A280, BCA), SDS-PAGE/western blotting
• Experience with Electronic Laboratory Notebook and sample management systems

Familiarity with one or more of the following areas is desirable:

• Transfer and validation of bioanalytical methods
• Bioanalytical content of non-clinical and clinical modules of regulatory submissions
• Custom reagent antibody campaigns
• Immunoprecipitation, hybrid assays, or chromatographic (LC/MS) based methods
• Cell-based bioanalytical assays (functional PK/NAb, flow cytometry)
• Work in a regulated environment (GXP) and/or with clinical samples

Annual Salary Range

$105,000.00 – $160,000.00