We are seeking an enthusiastic, highly motivated, and creative bioanalytical research associate/scientist. Key activities include assessments of analytes critical to our projects, including drug concentrations (PK), anti-drug antibodies (ADA), soluble ligands, antibodies and other soluble analytes, and ex vivo and in vitro cellular and immuno-phenotyping. The successful candidate will be responsible for the development, deployment, and trouble-shooting of critical assays and reagents and the analysis of clinical and preclinical samples.
- Bioanalytical design, trouble-shooting and performance of binding assays (e.g. FACS, ELISA, MSD), and cellular activity and phenotyping assays (e.g. luminescence, multiplex formats, flow cytometry)
- Method development and qualification of immunoassays (ELISA, MSD, etc.)
- Method development and qualification of multi-parameter flow-based assays
- Sample preparation techniques to measure and characterize biotherapeutics, ADA, and other soluble analytes in various biological matrices
- Analysis of samples from non-clinical and clinical studies in compliance with regulatory requirements (GLP/GCP)
- Demonstrates an appropriate level of understanding of immunology, inflammatory disease, immune-oncology, and protein therapeutics
- Maintains systems and adheres to SOPs for preclinical and clinical sample and reagent inventory tracking
- Analyzes, summarizes, and reports data at internal meetings to contribute to preclinical and clinical discussions and progress
- Collaborates with multidisciplinary teams to meet project goals on time and within budget
- Authors protocols and procedures with minimal supervision
Qualifications and Requirements
- Bachelor’s or Master’s Degree with five-plus (5+) years of experience in related scientific discipline or equivalent experience in related field
- Pharmaceutical, biotechnology, or CRO experience is highly desirable
- Proven track record of developing, troubleshooting, and qualifying/validating ligand binding, immunogenicity, neutralizing antibody, luminescence, multiplex array, and/or flow cytometric assays, as well as sample preparation methods. Working experience with additional formats is a plus.
- Experience working in a GLP/GCP environment and practical understanding of appropriate ICH/regulatory guidelines. CAP/CLIA experience highly desirable.
- Ability to independently operate and maintain laboratory equipment
- Proven problem solver who is highly organized with the ability to multitask, to work under constraint of timelines and budgets, and who thrives in a scientifically demanding environment with rapidly changing priorities
- Proficiency with computers and data analysis software (e. g. MS Word, MS PowerPoint, MS Excel, SoftMax Pro, GraphPad Prism, FlowJo)
- Ability and willingness to work effectively in a highly collaborative environment
- Excellent written and verbal communication skills and ability to draft technical reports
Alpine team members enjoy competitive salaries, equity participation (stock options), and an excellent benefits package including health and life insurance, a 401(k), and generous paid time off benefits.