About the Opportunity:
Appia’s growing Analytical Sciences team is seeking a passionate and motivated Associate Scientist. In this dynamic role, the ideal candidate will work collaboratively with R&D and Process Design to define and refine our understanding of in-process attributes and product quality attributes of Appia’s novel allogeneic cell therapy products. The Associate Scientist will work under guidance to develop and implement innovative and fit-for-purpose analytical methods to enable process development, product characterization, stability, and QC release testing of GMP manufactured products. In addition, they will author and review method development reports, test methods, SOPs, gap, and risks assessments and assist in the technical review of documents supporting regulatory filings.
Responsibilities:
- Employ quality by design (QbD) and design of experiment (DOE) approaches to quickly identify robust operating regions within phase-appropriate pre-defined acceptance criteria aimed to meet ICH guidelines
- Execute and document analytical method development activities and assay execution for the following techniques (depending on candidate’s expertise) towards enabling process development and product understanding
- cell culture/passaging
- immunophenotyping using multi-parametric flow cytometry
- plate-based immunoassays
- droplet digital PCR
- Work with Process Design in executing and documenting analytical methods as part of experimental study plans supporting the process development of Appia’s novel cell therapy platforms
- Author, review, and edit accurate technical documents related to method development & qualification, equipment usage, and training
- Provide technical guidance to junior staff by assigning duties, reviewing data, and reinforcing regulatory concepts (cGMP)
- Participate in group and department meetings by presenting scientific data and communicating expertise in areas of responsibility
- Maintain, calibrate, and operate analytical equipment and instrumentation that is used routinely in the execution of assays
- Ensure that departmental area is maintained per 5S guidelines
Minimum Qualifications:
- Bachelor’s degree in Biology, Immunology, Molecular Biology or related discipline with 8+ years of industry experience, or advanced degree (Masters of Science) in relevant discipline with 2+ years of industry experience
- Demonstrate expertise with developing and/or executing any or all of the following analytical methods
- plate-based immunoassays (e.g. ELISA, MSD, Luminex, AlpaLISA)
- multi-parametric flow cytometry
- mammalian cell-based potency assays (e.g co-culture, cytotoxicity, proliferation)
- droplet digital PCR using the QX200 (Bio-Rad)
- Experience with Good Documentation Practices and analytical method development for execution in a GMP environment
- Excellent skills in Microsoft Office and data analysis software (e.g. Prism, JMP, FlowJo, CytEpert, SoftMax Pro, Geneious)
- Ability to think critically and demonstrate troubleshooting and problem-solving skills
- Excellent interpersonal, verbal, and written communication skills
- Experience and aptitude in working in a multidisciplinary, fast-paced laboratory environment with moderate supervision
Preferred Qualifications:
- Experience with gene and/or cellular therapy cell products
- Knowledge in NK/NKT/T cell biology and cell signaling pathways
- Experience with mammalian cell culture including primary immune cells