Senior Scientist, Bioprocess R&D

ROLE SUMMARY

As a member of the Bioprocessing R&D Upstream Development department, the Senior Scientist will help drive the advancement of mRNA cell free synthesis technology including In Vitro Transcription (IVT) process development for mRNA manufacturing to support Pfizer's growing pipeline. As a Senior Scientist you will design and execute mRNA experiments and drive innovative collaborations and technology development projects to develop robust, scalable, and highly productive mRNA processes. Working with pilot scale, commercial and clinical production facilities you will deliver accurate technology transfer for successful large-scale production. The successful candidate will work with a team of scientists from diverse functional areas to enable the delivery of life-changing medicines to patients.

We are seeking a highly motivated and results-oriented self-starter who demonstrates personal accountability for outcomes and thrives on increasing levels of responsibility.

ROLE RESPONSIBILITIES

• Responsible for successful development, characterization and execution of state-of-the-art cell free IVT manufacturing processes for mRNA
• Apply scientific and technical experience and business acumen to establish strategies, drive safe and high-quality lab technical work and deliver well-controlled and characterized mRNA manufacturing processes
• Fosters colleague engagement and models desired values and behaviors, including quality, integrity, respect, collaboration and personal accountability
• Uses FDA/EMA Regulatory expectations to drive high quality, compliant manufacturing procedures and outcomes
• Contributes to Project, Technical and Strategic Teams as appropriate; reaches across organizational, functional and geographic boundaries to provide appropriate context and communication (in both directions) so as to ensure effective technical and strategic integration at all internal and external interfaces (Research, Bioprocess development, Analytical, Safety, CMOs, Commercial manufacturing, etc.), as appropriate.
• Establishes and drives relevant and impactful innovation programs, to enhance mRNA manufacturing/ characterization technologies and work-processes; ensures that innovation strategy is aligned with broader business drivers and current and emerging Regulatory paradigms.
• Ensures effective, high-quality, timely and appropriate documentation in electronic laboratory notebooks and internal Technical Reports; contributes to Regulatory Filings and responses to Regulatory questions; presents data/ strategy to scientists and management in appropriate internal and external venues (technical meetings, Project Team meetings, conferences) and publishes in peer-reviewed journals, as appropriate.
• Demonstrates leadership and capability to mentor junior colleagues, and fosters a team environment. Has the ability to troubleshoot scientific and technical challenges, and contribute to their resolution.

BASIC QUALIFICATIONS

• Degree in Chemical/Biochemical Engineering, Biotechnology, Cell Biology, Microbiology or a relevant field
• PhD with 0-3 years experience, MS with 6+ years' experience or BS with 9+ years' experience
• Relevant industry experience focused in the following: Development and characterization of cell free mRNA manufacturing processes for vaccines and therapeutics, Knowledge in developing cost effective, scalable cell free mRNA manufacturing processes, Scale-up/ Scale-down of mRNA processes, Knowledge in In Vitro Transcription processes for manufacturing mRNA.
• Demonstrated experience with managing multiple projects in parallel, including key participation on multi-disciplinary project teams.
• Advanced experience in upstream process development.
• Demonstrated success leading and executing independent research or technology development projects for the production of biologics.
• Self-motivated, organized, and capable of working independently and in a collaborative environment.
• Strong oral and written communication skills, attention to detail and demonstrated ability to execute detailed experimental plans, record procedures, analyze data, and present results. Ability to work in a fast paced team environment with changing priorities.
• Has a good understanding of enzymology related to mRNA processes.

PREFERRED QUALIFICATIONS

• Experience in statistical experimental design and analysis of biological processes
• Proficiency in using software tools for design of experiments, statistical analysis and data visualization - including Design-Expert, JMP, and Spotfire.
• Experience in the development of bioreactor scale-down models and process scale-up.
• Additional expertise/knowledge in operating lab scale mammalian or microbial culture bioreactor systems and computerized process control equipment.

PHYSICAL/MENTAL REQUIREMENTS

• Ability to perform mathematical calculations and ability to perform complex data analysis
• Capable of carrying out mRNA IVT experiments in the lab

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Travel to other Pfizer sites (St Louis MO, Andover MA and others) and to support process Tech Transfer to contract manufacturing organizations in USA/ Rest of World as appropriate

Other Job Details:

• Eligible for Relocation Package
• Eligible for Employee Referral Bonus
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Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment.  As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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Pfizer 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.  Pfizer 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.  Pfizer is an E-Verify employer.

Research and Development

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