Job Description

As a member of our Analytical Sciences team within the Technical Operations organization at Unum Therapeutics, this collaborative and driven scientist will develop and use state-of-the art analytical methods to support process development, formulation development and characterization of products. The successful candidate will critically evaluate scientific data and study protocols, will lead initiatives, and take part in, and lead cross-functional teams. In addition, this individual will be accountable for ensuring that analytical methods and data are fit-for-purpose.

Primary Responsibilities

• The primary role as a laboratory Scientist will be to develop and use cell-based and immunological assays to further understanding of key attributes in support of cell therapy process and product development.
• Participate in activities to support Unum’s pipeline within established timelines and ensure data quality and integrity
• Participate in cross-site method development, technology transfer and qualification activities and provide technical support to external vendors as required.
• Participate in design and execution of experiments and complete laboratory testing.
• Follow good documentation and review practices, and effectively communicate scientific results and strategies in presentations and written reports
• Draft technical reports, standard operating procedures and test protocols in support of analytical development.
• Maintain knowledge of and critically evaluate scientific literature and industry trends in order to contribute maximally to Unum’s development efforts.
• Proficiency in cell-based assays and ability to utilize techniques such as Flow Cytometry, cellular imaging, and immunoassay to analyze samples and document analytical results in a regulatory compliant manner under minimal supervision.

Qualifications

• PhD in the biological sciences with minimum of 2 years, MS with 6 years or BS with 10 years’ experience in development of bioanalytical methods
• Strong Cellular biology or Immunology experience with proficiency in functional characterization, flow cytometry and cell-based assay development is required
• Previous experience in the biopharmaceuticals industry or in cell therapy is strongly preferred
• Experience in T-cell biology and immunophenotyping is strongly preferred
• Experience with bioanalytical techniques such as ELISA, MSD, cytometric bead array, ELISpot and cell imaging is highly desired.
• Excellent oral and written communication skills and ability to document, organize, and present experimental data, conclusions and other information, including recommendations in a clear, concise and logical manner within function are required
• In-depth working knowledge of ICH Guidelines for Bioanalytical method validation is preferred.
• Experience with quality systems and electronic lab notebooks desirable
• Proficiency with data analysis tools such as FlowJo, FACSDiva, GraphPad Prism, Softmax, Stat-Ease Design-Expert , and JMP software is desirable

Additional Information

All your information will be kept confidential according to EEO guidelines.