Scientist, Assay Development

Role Summary

• Work under the guidance of a supervisor with high degree of independence.
• Responsible for the development of robust and reliable ligand binding and /or cell-based assays suitable for characterizing the disposition and immunogenicity of biotherapeutics in various biological matrices using a range of potential screening platforms and assay techniques.
• High degree of independence in the design, trouble shooting, validation and conduct of the assay to support biotherapeutic programs.

Responsibilities

• Laboratory focused position to design, develop and implement ligand binding assays (e.g. ELISA, ECL detection) in biological matrix (plasma, serum) to measure compound concentration, detect the presence of anti-drug antibody and neutralizing anti-product antibody activity utilizing various platforma in a regulated (GLP, GCP) environment against challenging time lines.
• When needed, participate in the design, development and implementation of cell-based assays.
• (optional) Design, develop and/or implement PCR assays in biological matrix (solid tissues, biofluid) to measure RNA and DNA molecular copies in a regulated (GLP, GCP) environment.
• Perform data analysis and interpretation and be able to draw conclusions regarding progress and results of work, utilizing the data in appropriate decision making.
• Gathers input from colleagues, literature, and additional resources to assist in driving the project forward.
• Timely delivery of concentration and immunogenicity data to a supervisor and other partners in compliance with local or global regulatory requirement.
• Advancing bioanalytical capabilities to improve efficiency, cost effectiveness and appropriateness of assay for regulated support.
• Development and validation of assays to be governed per departmental SOP.
• Accurate execution and documentation of bioanalytical method in a regulatory compliant manner.
• Ensure GLP and GCP compliance is maintained in laboratory during study support

Basic Qualifications

• BSc with at least 5+ years relevant GLP/GCP laboratory experience, with a focus on ligand binding assay development in biological matrix (plasma, serum) and/or cell-based assay experience; MSc with at least 3+ years relevant GLP/GCP laboratory experience with a focus on ligand binding assay development in biological matrix (plasma, serum), cell-based assay experience. MSc with foreign degress equivalent in chemistry, biology, or related field with relevant laboratory experience described above and/ or on PCR assays.
• Knowledge and hands-on experience developing ligand binding assays, utilizing various platforms.
• Industry experience with a focus in biotherapeutics and a strong record of scientific achievement.
• Proven track record in the area of biotherapeutics bioanalysis with understanding of a broad range of bioanalytical platforms.
• Skills in GLP/GCP compliant analysis including following SOP and provision of quality regulatory documents.

Preferred Qualifications

• Experiences worked on qPCR or ddPCR assay development detect copies of mRNA and DNA in biological matrix (plasma, serum) a plus .
• Excellent communication and presentation skills .

PHYSICAL/MENTAL REQUIREMENTS

This is a laboratory based position, the activities may include light l ifting, sitting, standing, walking, bending. Ability to perform mathematical calculations and ability to perform complex data analysis are required.

Other Job Details

Eligible for Employee Referral

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