Senior Associate Scientist, Bioassay & Impurity Testing (Non PhD)

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients

What You Will Achieve

ROLE SUMMARY

We are seeking candidates 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. Working within a team setting, the qualified candidate will contribute to the development of gene therapies (e.g., adeno-associated virus), vaccines, therapeutic proteins and monoclonal antibodies with emphasis on a range of qPCR assays, immunoassays and cell-based bioassays. The qualified candidate will be responsible for performing analytical methods to monitor the intended mechanism of action of drug candidates and to ensure residual process -related impurities are controlled. This data is required to elucidate structure-function and to confirm suitable quality of clinical supplies in a broad biologics portfolio. The candidate will work across analytical functions and projects and will also provide technical counsel to other organizations and senior leadership.

The Senior Associate Scientist position within the Bioassay and Impurity Testing Group is responsible for the development, maintenance and testing of bioassays to evaluate the potency of biological candidates in clinical development. The methods may be used for characterization for a range of biological candidates in clinical development and process development. The successful candidate will have a thorough understanding and knowledge of cell culture and the development of qPCR assays, immunoassays and cell-based functional assays. Prior experience working in a cGMP environment is highly desirable, as well as any experience in assay validation. Excellent writing skills and the ability to document and communicate results to a wide array of scientists and management will be critical. Ability to multitask while working with multiple people in a team-based environment is a requirement.

How You Will Achieve It

• Responsible for performing and troubleshooting qPCR assays, immunoassays, and cell-based assays for early and late stage products in a GMP environment.
  
• The candidate is expected to document and report lab work according to GMP practices.
  
• The candidate must be able to interact effectively with multi-disciplinary project teams.
  
• The candidate is expected to tabulate data, provide data interpretation to their teams and to their customers.
  
• The candidate is expected to revise, review, and author test methods and technical reports.
  
• The candidate is expected to perform method development, qualification, validation and transfer in a cGMP environment.
  
• Working within a team setting, the qualified candidate will be responsible for developing immunoassays and cell-based assays to monitor the intended mechanism of action of drug candidates.
  

Qualifications

Must-Have

• Bachelor's degree in biology, biochemistry, cell biology, immunology or related field with 3+ years of experience developing and performing qPCR, cell-based assays and immunoassays OR Master's degree in biology, biochemistry, cell biology, immunology or related field
  
• Proven record of delivering results in a fast-paced environment and effective communication to project teams
  
• Demonstrated technical writing skills and good interpersonal skills
  

Nice-to-Have

• Experience in GxP (GLP, GMP) environment and implementation of continuous improvement practices
  
• Experience with ddPCR
  
• Experience with cell-based assays such as infectivity assays
  
• Experience with ELISA assays
  
• Experience with method qualifications and validations
  
• Experience with AAV vectors strongly.
  
• Experience with biotherapeutic development
  
• Comfortable and effective in a team-based, fast-paced environment where multi-tasking.
  

PHYSICAL/MENTAL REQUIREMENTS

• Position requires occasional light lifting and periods of standing, sitting or walking.
  

PHYSICAL/MENTAL REQUIREMENTS

• Position requires occasional light lifting and periods of standing, sitting or walking.
  

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Standard M-F, 1st shift work schedule, in a regulated biological laboratory.
  
• May occasionally require evening / weekend support and travel.
  

Other Job Details:

• Last Date to Apply for Job: August 20th, 2022
  
• Work Location On Premise: colleagues work in a Pfizer site because it's needed to get their job done. They may have flexibility to work remotely from time to time, but they are primarily on-site.
  

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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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