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Principal Scientist, Virus Production

Employer
Pfizer
Location
Pearl River, New York
Salary
Competitive
Closing date
Feb 10, 2023

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Sector
Science, Pharmaceutical, Supply Chain, Quality Assurance
Hours
Full Time
Organization Type
Corporate
Jobseeker Type
Professional
ROLE SUMMARY

You will lead the Early Bioprocess Development (EBPD) effort to optimize and scale up virus production from mammalian cells to support vaccine development and clinical testing. Your primary responsibility is to produce a variety of viruses including BSL-3 level with decent titer and consistency at large scale using different vessels and technology. You will also lead a team to produce viruses with quality and lightning speed to meet timelines for different vaccine projects, allocate resources and schedule for virus production runs, purify, aliquot and curate viruses for clinical testing, optimize large scale virus production runs in bioreactors, troubleshoot when unexpected results occur, collaborate with analytical team to generate QC report, keep batch record and QC documentation for different virus batches.

ROLE RESPONSIBILITIES
  • Lead a team of scientists to produce different types of viruses with decent titer and consistency at large scale using different host cells and vessels such as disposable bioreactors, wavebags, iCellis, CelCradle, cell factory, etc. to support viral vaccine development and clinical testing
  • Optimize cell culture and virus production using automatic bioreactors such as AMBR250 with DOE principle which focuses on characterization, scale-up, and demonstration of process robustness
  • Develop fast and high throughput in process assays such as molecular, biochemical, biophysical, or biological assays to characterize and improve virus product and upstream process
  • Produce viruses in both BSL-2 and BSL-3 level using either suspension cells or adherent cells
  • Purify, aliquot and curate viruses using different technologies for clinical testing
  • Generate and keep track of batch records for virus production runs
  • In collaboration with customers and analytical team, define critical quality attributes and target product profile for different types or strains of viruses based on the principle of QbD
  • Keep track of virus QC reports, seed, passage history, sequence variation and other critical information
  • Maintain host cell culture and virus seed for different virus production runs
  • Collaborate with colleagues within EBPD including Upstream process development, Purification, Analytical, and Formulation Development groups
  • Establish relationships and collaborative working alliances outside of Vaccines Early Bioprocess development such as vaccine research and high throughput clinical testing
  • Propose solutions to scientific problems and offer insights based on experience to direct reports and other collaborating scientists
  • Plan and prioritize virus production related activities for the group
  • Lead the evaluation and implementation of new technologies to improve virology production
  • Author and review virus culture procedures and reports, relevant parts in patent application and IND enabling documentation
  • Represent the virus production group in relevant project sub team meetings. Maintain detailed records of the meetings and keep management informed as to progress or issues.
  • Keep abreast of scientific/ technological development by participating in scientific meetings/ seminars and through regular scientific review.
  • Perform timely notebook entries and review for completed experiments.


QUALIFICATIONS

Must Have
  • PhD in Virology, Chemical Engineering, Microbiology, Immunology, Cell Biology, or other related discipline with a minimum of 3 years of related virus production experience, MS degree with a minimum of 10 years related virus production experience, or BS degree with a minimum of 15 years of related virus production experience in academia, a biotech and/or a pharmaceutical environment
  • Significant hands-on experience in mammalian cell culture and virus production using different vessels such as bioreactors, wavebags, e.g., iCellis
  • Significant experience working with different types and strains of viruses
  • Experience with both suspension and adherent cell culture for virus production
  • Experience designing experiments to optimize mammalian cell culture and virus production in bioreactors based on DOE principle
  • Experience leading/managing a small team


Nice to Have
  • Experience designing, organizing, prioritizing, and executing multiple complex experiments
  • Experience with disposable bioreactor/AMBR/Perfusion/iCELLis/continuous processing
  • Experience with virus purification and analytics such as UF/TFF, ultracentrifugation, chromatography, HA assay, plaque assay, TCID/50, FFA, qPCR, flowvirometry
  • BSL-3 lab experience and related regulatory knowledge such as GMP manufacturing considerations are preferred
  • Experience planning project workflows and keeping track of records for different projects


PHYSICAL/MENTAL REQUIREMENTS

The ability to make aseptic transfers and perform the relevant laboratory functions.

Mental requirements are a detailed understanding of the scientific subject matter, an ability to make scientific judgments and an ability to perform complex data analysis.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Works irregular hours (weekends and outside of 9-5 format) as experiments warrant

Relocation support available

Work Location Assignment:On Premise

Relocation assistance may be available based on business needs and/or eligibility.

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.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

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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