Pfizer

Senior Scientist, Analytical R&D, Gene Therapy

Employer
Pfizer
Location
North Carolina - Morrisville, North Carolina
Salary
Competitive
Posted
April 08 2021
Ref
4809463
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 join the Analytical R&D organization to enable development of gene therapies in Morrisville, NC, and will work with a multi-disciplinary team performing analysis in an R&D and/or regulated environment in support of clinical biotherapeutic, vaccine, and gene therapy candidates.

You will be recognized as a technical expert and a scientific contributor whose decisions impact the projects. You will be consulting on the analytical strategy for these projects to ensure it is sound and effectively executed. You will be responsible for applying analytical methods in the assessment of product quality, biological activity, detection of impurities, and/or structural characterization.

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.
  • Develop, troubleshoot, and utilize analytical methodologies to support process and formulation development of medicines, including viral vectors, plasmids, and residual impurities.
  • Prepare and review technical documents, including validation protocols and reports, analytical test procedures, investigation reports, and change controls.
  • Develop 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 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.
  • 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 chemistry, biochemistry, biology or related field with 0-5 years relevant experience in the research and development of molecular therapies.
  • Demonstrated technical skills and scientific expertise in analytical method development and troubleshooting.
  • Demonstrated experience with both analytical laboratory data as well as process data.
  • Experience in analysis of large molecules and vaccines.
  • Experience working in a regulated environment, such as Good Laboratory Practices {part of GxP}.
  • Strong written and verbal communication skills.
  • Strong MS Office skills.


Nice-to-Have
  • Experience in the pharmaceutical industry space.
  • Knowledge of analytical techniques including but not limited to HPLC, real-time PCR, cell-based assays, DNA sequencing.
  • Experience with laboratory data systems such as Laboratory Information Management Systems.


PHYSICAL/MENTAL REQUIREMENTS
  • Ability to stand, walk, bend, sit, lift, operate a pipet, and perform mathematical calculations and data analysis.


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
  • Abilityto adhere to safe work practices and procedures. Occasional travel might be required.


Other Job Details:
  • Last Date to Apply for Job: April 8, 2021
  • Eligible for Employee Referral Bonus: YES
  • Eligible for Relocation Package: YES


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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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