- Why Patients Need You
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.Job Description
The qualified candidate must have training and experience with molecular based techniques, including isolation of DNA and RNA templates, reverse transcriptase PCR, and qPCR. The candidate to meet aggressive timelines within the Quality Science and Technology and Quality Control Microbiology groups. Participate in the routine testing of samples that required PCR based assay. May potentially participate in instrument validation, as needed, and method validation, in PCR based technologies. The candidate will be able to provide results and understand if the assay is valid or invalid. Candidate will be able to support any deviations or laboratory investigations in support of the PCR based assays. The candidate will be able to represent the Quality Science and Technology and Quality Control Microbiology group at internal meetings.ROLE RESPONSIBILITIES
- Performs all work in compliance with cGMPs and site requirements.
- Performs DNA and/or RNA extraction and PCR -based assays, including RT-PCR, qPCR, ddPCR, for the routine testing and qualification/validation of new methods.
- Support product investigations, method improvements, troubleshooting for PCR-based assays and other assays as needed.
- Support instrument validation activities for Quality Science and Technology, focused on PCR instrumentation
- Recognizes atypical or out-of-specifications test results, instrument malfunctions and methodology problems.
- Accountable for the accuracy and validity of testing results. Reviews and validates data. Interprets results, performs or reviews mathematical calculations, and records observations using Laboratory notebooks or other controlled documentation.
- May train less experienced analysts in existing procedures, techniques and governmental regulations.
- Oversees maintenance of all related records and ensures that laboratory work area is maintained in a neat, orderly, and compliant manner. Suggests continuous improvements to systems, procedures, etc. Carries out technical and administrative duties as needed.
- BS in Microbiology or related field with 2+ years of molecular technique experience, preferably in the biopharmaceutical industry
- Good understanding/knowledge and practical application of relevant techniques associated with PCR/qPCR and classical molecular techniques. Demonstrated ability to perform qPCR assays and analyze qPCR data.
- Preferred to have proven record of technical writing skills, such as scientific reports, publications, journal articles, technical papers, method validation reports, etc.
- Demonstrated ability to independently perform routine tasks and engage in a team that is highly dynamic and fast paced.
- Proficiency with MS Word and Excel
- cGMP experience is a plus but not required
- Nice to Have: Direct experience with ddPCR technology.
60% time in lab, 40% desk work. Ability to follow complex calculations. Ability to sit in BSC for multiple hours. Ability to perform small volume pipetting.
Last Date to Apply: October 10 2022
Relocation assistance may be available based on business needs and/or eligibility.
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.
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.
Quality Assurance and Control