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All over the world, the company colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. the company, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
We are seeking a highly determined, results-oriented, self-starter who demonstrates personal accountability for outcomes and thrives on increasing levels of responsibility, to join a new and dynamic team responsible for successful development and characterization of clinical-scale manufacturing processes for Chimeric Antigen Receptor T cell (CART) therapies. The successful candidate will bring cellular immunology skills to contribute to in vitro fit-for-purpose functional assessment including understanding the potential process/ product and mode-of-action ('potency') relationships during development and manufacturing of allogeneic CART. This position will be responsible for the generation, integration, analysis and interpretation of T cell immunology data. He/ she will collaborate with team members and key stakeholders, including the CART Research, Process Development and Analytical R&D groups.
• Actively contribute to generating data and knowledge of in vitro T cell biology in order to enable heightened characterization of engineered T cells in order to inform product understanding and comparability in support of process development and manufacturing.
• Participate in the design, implementation, and execution of in vitro T cell immunology studies to understand process/ product relationships, donor-to-donor/ batch-to-batch variability and identify critical cellular quality attributes.
• Sponsor the development and implementation of new and existing tools to assess T cell health and activity.
• Deliver potential mode-of-action hypotheses using T cell functional data sets.
• Provide analytical support for clinical-scale non-GMP/ GMP manufacturing operations.
• Contribute to relevant and effective innovation programs to enhance CART characterization technologies.
• Contribute to project technical teams to ensure integration at all levels. Communicate and collaborate effectively to ensure productive interactions with all stakeholders.
• Demonstrate strong personal leadership and accountability, as well as good interpersonal skills.
• Apply sound scientific and technical experience to establish safe, high-quality lab practices.
• Ensure timely documentation in electronic laboratory notebooks and technical reports, and contribute to regulatory filings and responses as appropriate.
• Present data and strategy to scientists and management, in internal and external venues, as well as publish in peer-reviewed journals, as appropriate.
PhD in immunology, cellular and molecular biology, or a related discipline is preferred. Must have 2-3 years of relevant industry or academic experience generating and analyzing T cell immunology data and demonstrate advanced analytical and troubleshooting skills.
• Extensive skills in in vitro methods to assess T cell biology and immunological activity particularly in applications related to immuno-oncology.
• Solid skills in cell line and primary immune cell tissue culture, with emphasis on assays and technologies commonly used to characterize genetically modified primary T cell subset cultures (such as by lentiviral vectors and/or gene-editing modalities).
• Demonstrated expertise applying knowledge-based or data-driven methods for scientific data interpretation and visualization solutions (e.g., pathway and network analysis).
• Excellent data science skills in the areas of analysis, integration, and interpretation from internal or external data sources.
• Ability to interact productively w/ external investigators and corporate partners.
• LIMS development experience is a plus.
• Familiarity with cGMP and relevant Regulatory Guidance documents.
Other Information - Internal
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.
EEO & Employment Eligibility
the company is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. the company also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. the company is an E-Verify employer.
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