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

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Job description

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

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.

What You Will Achieve

• 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 in biology, biochemistry, cell biology, immunology or related field with 3-6 years of experience; or Master's with relevant experience.
• Experience developing and performing qPCR, cell-based assays and immunoassays
• Proven record of delivering results in a fast-paced environment and effective communication to project teams
• Demonstrated technical writing skills and good interpersonal skill

Nice-to-Have

• Experience in GxP (GLP, GMP) environment and implementation of continuous improvement practices
• ddPCR experience
• Method validation experience
• Experience with biotherapeutic development
• Comfortable and effective in a team-based, fast-paced environment where multi-tasking required

PHYSICAL/MENTAL REQUIREMENTS

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

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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