Pfizer

Senior Scientist - Analytical R&D, Bioassay & Impurity Testing

Employer
Pfizer
Location
Chesterfield, Missouri
Salary
Competitive
Posted
March 04 2021
Ref
4805623
Position Type
Full Time
Organization Type
Pharma
Job Type
Senior Scientist
Why Patients Need You

Pfizer's purpose is to deliver breakthroughs that change patients' lives. Research and Development is at the heart of fulfilling Pfizer's purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world.

Role Summary

We are seeking a candidate to join us in building capabilities to lead the industry in the advancement of novel products to the market through innovation and execution of analytical testing. This position will provide laboratory support and contribute data and knowledge to the development of vaccines, therapeutic proteins, gene therapies, and monoclonal antibodies with emphasis on mammalian cell-based bioassays including in vitro expression assays using flow cytometry, a range of immunoassays and PCR technologies. Working with a team setting, the qualified candidate will be responsible for developing analytical methods to monitor the intended mechanism of action of drug candidates and to confirm residual host impurities are controlled. These methods will be required to elucidate structure-function and to confirm suitable quality of clinical supplies in a broad biologics portfolio, including vaccines. The candidate will work across analytical functions and projects and will also provide technical counsel to other scientists, organizations, and senior leadership.

Role Responsibilities
  • Provide analytical testing support and contribute to assay development/optimization for mRNA based vaccines using flow cytometry.
  • Prepare and review technical documents, including validation protocols and reports, analytical test procedures, investigation reports, and change controls.
  • Perform job responsibilities in compliance with {Current} Good Manufacturing Practice and all other regulatory agency requirements, where applicable.
  • Manage development, qualification, validation, and transfer of cell-based, PCR and immunoassays in support of diverse portfolio in varying stages of clinical development.
  • Provide training, technical expertise and support to the analytical staff.
  • Analyze and communicate experimental results both orally and in written reports to colleagues and management.
  • Provide the necessary documentation for regulatory submissions as required and writes deficiency responses.
  • Review and verify scientific experiments and data documented in electronic laboratory notebooks and technical reports.


Qualifications

Must-Have
  • PhD in immunology, cell biology, biochemistry, virology, or closely related field with 0-5 years experience or BS/MS with significant, relevant experience.
  • 1-2 years experience with flow cytometry technology.
  • Demonstrated technical skills and scientific expertise in cell-based assay, immunoassay and qPCR analytical method development and troubleshooting.
  • Strong written and verbal communication skills.



Nice-to-Have

  • Experience in the pharmaceutical industry space.
  • Experience in GxP, (GLP, GMP) environment and implementation of continuous improvement practices.
  • Proven record of delivering results in a fast-paced environment and effective communication to project teams.
  • Method validation experience.


PHYSICAL/MENTAL REQUIREMENTS
  • Position requires occasional light lifting and periods of standing, sitting or walking.


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
  • Occasional travel to other Pfizer sites or external meetings.


Other Job Details:
  • Last Date to Apply for Job: March 16, 2021
  • Eligible for Relocation Package: YES
  • Eligible for Employee Referral Bonus: YES


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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