Bioanalytical Scientist, Regulated
This scientist provides quantitative bioanalytical support for regulated preclinical and clinical studies for Pfizer’s small-molecule drug candidates. They will provide technical and scientific support for assay method development, validation and study support using state of the art mass spectrometry. The applicant will develop precise and rugged methods for the extraction of small molecules from biological matrices. Analyte selectivity and accurate quantitation will be achieved through liquid chromatography/triple-quadrupole mass spectrometry. Assay validation and study support will be rigorously documented by the scientist according to the expectations of global regulatory agencies.
- Responsible for the development of procedures such as protein precipitation, liquid-liquid, and solid-phase extraction that isolate drug molecules and their targeted metabolites from biological fluids.
- Responsible for the development of liquid-chromatography/mass-spectrometry methods for the quantitation of analytes.
- Responsible for the validation and execution of bioanalytical assays according to the acceptance criteria set by global regulatory agencies.
- Documents contemporaneously assay validation and study support at a level that meets the expectations of global regulatory agencies.
- Interacts with internal partners for the delivery of study data. Interacts with external partners for the transfer and troubleshooting of bioanalytical assays.
- Bachelor’s degree or Master’s degree in chemistry, biology, or an allied area of study with 2-5 years of experience in a regulated bioanalytical laboratory.
- Ph.D. level candidates will not be considered for this role.
- Experience in developing procedures for the extraction of analytes from biological matricies.
- Experience in the operation, maintenance and troubleshooting of liquid-chromatorgraphy systems
- Experience in the operation, maintenance and troubleshooting of triple-quadrupole mass spectrometers
- Experience with WATSON laboratory information management system.
- Experience with IDBS e-workbook documentation.
This scientist will work in a laboratory environment and will be required to sit and stand in front of laboratory benches, computers, and instrumentation. They will be required to lift and carry 4-liter bottles of solvent. The scientist will be required to work with animal and human biological fluids. They will work with new chemical entities whose pharmacological and toxicological effects are unknown and are under investigation.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
This scientist is expected to maintain a flexible work schedule which will occasionally require evening and weekend work. They may be occasionally asked to travel to our external partners and to scientific conferences.
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 ActPfizer 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 EligibilityPfizer 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