Pfizer

Scientist

Employer
Pfizer
Location
Chesterfield, Missouri
Salary
Competitive
Posted
October 12 2021
Ref
4827874
Position Type
Full Time
Organization Type
Pharma
Job Type
Staff 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 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. With your deep knowledge in the discipline, you will be an active team member who influences at the project team level. 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 and consulting others. Your ability to plan will help in preparing short-term work activities on projects. Your creativity in developing novel processes and new ideas will be used frequently. You will undertake mentoring activities to guide your team members.

It is your hard work and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

  • Contribute to achievement of goals and influences at the work group/project team level.
  • Assist in the establishment of analytical procedures and interpret results/technical data.
  • Communicate progress, plans, requirements and risks to the senior analyst, manager, stakeholders in partner groups and higher management informally and, if required, formally through written reports and presentations.
  • Actively participate and report progress into cross-functional project teams to meet customer expectations, project milestones and Good Manufacturing Practices {also cGMP} standards.
  • 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.
  • Support development, qualification, validation, and transfer of cell-based and immunoassays in support of diverse portfolio in varying stages of clinical development.
  • 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.


ROLE SUMMARY

The qualified candidate will join the Analytical R&D organization to enable development of biological therapeutics in Chesterfield, MO. The qualified candidate will be responsible for applying analytical methods in the assessment of product quality, biological activity, detection of impurities and characterization. This group performs testing in the R&D and/or regulated settings in support of clinical drug candidates. The group also supports method development, transfer, verification, qualification and validation as well as troubleshooting.

ROLE RESPONSIBILITIES

The qualified colleague is responsible for utilizing established analytical methodologies to support GMP in-process, release, and stability testing of clinical supplies. The colleague will have experience in a breadth of analytical methodologies including HPLC, ELISA, electrophoresis and compendial assays. The colleague must work within corporate guidelines and must appropriately record, archive and report all data as this is a cGMP compliant laboratory. The colleague must be able to interact effectively with peers and leaders as part of a multi-disciplinary team. The colleague is expected to revise/review/author test methods and technical reports. The candidate must thrive in a fast-paced environment. Attention to detail, strong organizational skills, the ability to multitask and effective interpersonal, influencing skills and communication skills are required.

BASIC QUALIFICATIONS

MINIMUM: BS or MS in biochemistry, molecular/cell biology, immunology, analytical chemistry or related field with 5+ years of industrial experience
  • The colleague must be able to interact effectively with peers and leaders as part of a multi-disciplinary team across multiple geographies.
  • The colleague must thrive in a fast-paced environment.
  • Attention to detail, strong organizational skills, the ability to multitask and effective interpersonal, influencing skills and communication skills are required.


PREFERRED QUALIFICATIONS
  • Experience with development of vaccines, gene therapy, MAbs and other large molecule products.
  • Experience with the development, qualification, validation and troubleshooting of analytical methods.
  • Experience with method development over a wide variety of large molecule technologies.
  • Ability to follow established procedures under minimal supervision.
  • Experience in analysis of large molecules.
  • Experience with laboratory data systems such as Empower, and Laboratory Information Management Systems
  • Some knowledge of drug development process for progression of biological colleagues.
  • A strong familiarity with 21 CFR Part 210 and 211, ICH and Compendia guidelines (USP, EP, JP) within the frame work of QC biological testing is preferred.
  • Experience leading laboratory investigations, deviations and CAPAs in a regulated environment is desirable. As well as, regulatory experience and work within the operations of GMP environment is desirable.


PHYSICAL/MENTAL REQUIREMENTS

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

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

N/A

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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