
Senior Scientist
The Senior Scientist, Analytical Development will be responsible for leading development of flowcytometry-based assays for release and characterization of engineered T-cell products and analytics for process understanding. The successful candidate will be responsible for leading a group within Analytical Development and mentoring scientists, hands-on assay development and driving projects in close collaboration across TechOps and research.
In this role you will work closely with other members of the analytical development team to develop strategy, conduct experiments, develop test methods, and assist in the tech transfer of analytical methodologies into a GMP manufacturing and QC testing facility. The successful candidate will have expertise in flowcytometry based assay development, experience with analytical testing methodologies and an understanding of the technological requirements to execute on testing and characterization needs of a cellular therapy company.
Essential Functions:
- Design, develop, execute, and document flowcytometry analytical methods for release testing and to study processes for production of T cell therapies
- Critically analyzes, interprets complex data drawing appropriate conclusions
- Support product characterization activities, including comparability assessments in support of product life cycle management
- Act as a subject matter expert in providing analytical and data interpretation both internally and externally
- Partner in the transfer of qualified assays to QC, and support assay validation and investigations
- Responsible for completion of assignments that have an impact on functional goals
- Develop and deliver scientific presentations, prepare clear and concise technical reports, participate in project teams, and contribute to regulatory filings, as needed
- Participate in the evaluation of new analytical technologies and their implementation
- Revise, review, and author assay standard operating procedures
- Contribute to building a culture that encourages continuous learning, improvement, and innovation, and encourages team members to expand their technical skill base
Education:
- Must have a PhD in cell biology, immunology or related field with at least six years’ relevant industry experience or an MS with at least 11 years of relevant industry experience
Preferred Experience & Skills:
- A minimum of 10 years of extensive experience in developing flow-based assays
- Well versed with various flowcytometers such as MACSQuant, BD Lyric and Cytek Aurora.
- Experience in a wide variety of analytical techniques such as cytotoxicity assays, flow cytometry, cytokine release assays, cell counting and other applicable methods is a plus
- Prior experience of leading and managing scientific teams
- Experience in analytical development, cGMP QC testing and implementation of new technologies in a regulated environment
- Experience with assessment of new technologies in a fast-paced, learning organization; preferably in a cross-functional setting where impact of new technologies is evaluated across research, development and commercial organizations
- Prior experience in cell therapy development preferred
- Must have excellent oral and written communication skills
- Proven ability to work independently and collaboratively among cross-functional teams
- Ability to work efficiently, prioritize workflow, meet deadlines and balance competing priorities
- Excellent analytical skills and technical expertise
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