Pfizer

Senior Scientist (PhD), Bioassay and Impurity Testing

Employer
Pfizer
Location
Chesterfield, Missouri
Salary
Competitive
Posted
October 07 2021
Ref
4817182
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.

What You Will Achieve

As a Senior Scientist, you will be at the center of our operations and you'll find that everything we do, every day, is in line with an unwavering commitment to quality. You will be recognized as a technical expert and a scientific contributor. With your deep knowledge of the discipline, you will be an active team member whose decisions impact the project. You will perform qualitative and quantitative analyses of organic, inorganic compounds, or biologics to determine chemical and physical properties during chemical syntheses, fermentation or drug product development process.

You will be using your scientific judgment to adapt standard methods and techniques by applying prior work experience. You will be forecasting and planning resource requirements for your project team. Your creativity in developing novel processes and new ideas will be used frequently. You will undertake mentoring activities to guide team members.

It is your innovative scientific temperament that will help in making Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

  • Regularly contribute and influence at the project team level.
  • Prepare and review technical documents, including validation protocols and reports, analytical test procedures, investigation reports, and change controls.
  • Develop analytical methodologies and strategies needed to progress biotherapeutic products in the pipeline.
  • Perform job responsibilities in compliance with {Current} Good Manufacturing Practice {part of GxP} Good Laboratory Practices {part of GxP} and all other regulatory agency requirements, where applicable.
  • Work directly with parties beyond Pfizer Essential Health (PEH) PharmSci/R&D, including but not limited to 3rd party analytical labs, Contract Manufacturing Organizations, and involvement with other divisions of Pfizer.
  • Accountable for assembling multi-disciplined teams to assess the scope of problems and implement solutions.
  • Manage development, qualification, validation, and transfer of cell-based 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.
  • Support formulation development, generate analytical data to be used for regulatory submissions, participate in technology transfer activities to manufacturing sites and provide formulation support in developing new products.
  • Review and verify scientific experiments and data documented in electronic laboratory notebooks and technical reports.


ROLE SUMMARY

Bioassay and Impurity Testing Group: 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 gene therapies (e.g., adeno-associated virus) with emphasis on PCR technologies (qPCR and ddPCR), cell-based bioassays, and, a range of immunoassays. Working within 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. This data is required to elucidate structure-function and to confirm suitable quality of clinical supplies in a broad biologics portfolio with a primary focus on gene therapy (viral vectors). The candidate will work across analytical functions and projects and will also provide technical counsel to other scientists, organizations and senior leadership.

ROLE RESPONSIBILITIES
  • Designing and performing qPCR experiments and leading the advancement of new DNA technologies to support robust assay development and product understanding.
  • Developing, performing, and troubleshooting PCR assays (qPCR and ddPCR), cell-based assays, and immunoassays, while applying these methods to abroad range of biotherapeutics.
  • Documenting and reporting lab work according to GMP practices
  • Effectively interacting with multi-disciplinary project teams.
  • Learning quickly independently and from others
  • Providing data analysis and interpretation to teams and customers.
  • Authoring, revising, and reviewing test methods, technical reports and regulatory content.
  • Mentoring colleagues on scientific and strategic directions.


BASIC QUALIFICATIONS
  • Ph.D. in immunology, cell biology, virology or closely-related field with 0-5 years of experience
  • M.S. with 7+ years of significant, relevant experience
  • B.S. with 9+ years of significant, relevant experience
  • Excellent technical writing and verbal presentation skills. Outstanding leader behaviors and the ability to collaborate and mentor others.
  • Experience developing and performing qPCR and ddPCR assays, cell-based assays and immunoassays


PREFERRED QUALIFICATIONS
  • Proficiency in DNA technologies such as primer/probe design, ddPCR, qPCR, and sequencing data interpretation
  • Viral vector experience
  • Proven record of delivering results in a fast-paced environment and effective communication to project teams
  • Experience in GxP (GLP, GMP) environment and implementation of continuous improvement practices
  • Method validation experience


PHYSICAL/MENTAL REQUIREMENTS

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

Other Job Details:
  • Last Date to Apply for Job: October 19, 2021
  • Eligible for Employee Referral Bonus: YES
  • Eligible for Relocation Assistance: YES


#LI-PFE

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

#LI-PFE

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