Scientist I/II, Analytical Development
About The Position
The incumbent will work within the analytical development team to develop and/or optimize flow cytometry and cell-based assays to support the characterization and release of our allogeneic, natural killer (NK) cell-based therapies. In this role, the incumbent will participate in the evaluation and development of new flow cytometry and potency assay methods and perform product characterization for NK cell products. This role includes participating in benchtop assay development/performance, detailed documentation of methods and materials, writing SOPs/reports and communicating findings to the wider group. S/he will collaborate closely with R&D and Process Development teams to identify relevant characteristics that advance optimal product development and function. S/He will also participate in assay optimizations, standardizations, and transfers to QC labs.
Requirements
- Ph.D. degree in a relevant scientific discipline (e.g., Immunology, Microbiology, Cell or Molecular Biology or Biochemistry) with 2+ years or MS with 5+ years of industry experience in analytical development or equivalent demonstrable experience with analytical techniques.
- Expertise (equipment and software) with flow cytometry, plate readers, and automated cell counters required.
- Strong organizational, recording keeping, time management, and communication skills are required.
- Excellent interpersonal, verbal, and written communication skills are essential.
- Able to manage multiple projects in parallel, including key participation on multi-disciplinary project teams.
- Attention to safety, good laboratory practice, and good documentation practice.
Nice To Haves
- In-depth experience in analytical techniques such as ELISA/MSD and qPCR/ddPCR is highly desirable.
- Expertise in cell potency-based assay development is highly desirable.
- Experience with NK and or CAR-T cells is highly desirable.
- Experience with assay qualification/validation is a plus.
- Experience in analytical development and testing in a Pharma/Biotech, regulated (GXP) environment is strongly preferred.
- Experience in cell therapy, immunology, or oncology is preferred.
- Experience with statistical programming or software (e.g., JMP) is a plus.
Responsibilities
- Contribute to experimental design and execution enabling assay development, optimization, and characterization studies to enhance process understanding
- Research and compare novel platforms to provide more optimal methods of characterizing in-process and final drug product
- Collaborate with analysts within the analytical development, product development, research and early development, and quality control departments.
- Develop assays to support process development, clinical product release and stability, and product characterization needs.
- Execute routine laboratory experiments and maintenance to generate high-quality data
- Contribute to assay qualification and validation studies
- Draft technical reports, standard operating procedures, and test protocols in support of analytical test method development
- Manage assay transfer to the Artiva QC team and external partners where applicable
- Present data to cross functional team meetings to discuss findings and next steps
Benefits
- Medical, Dental, and Vision
- Group Life Insurance
- Long Term Disability (LTD)
- 401(k) Retirement Plan
- Employee Assistance Program (EAP)
- Flexible Spending Account (FSA)
- Paid Time Off (PTO)
- Company paid holidays, including the year-end holiday week
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
