Principal Scientist Molecular Diagnostic Assay Development
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 Principal 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. You will have the important role to generate high-quality molecular data in a regulated laboratory setting to support Pfizer’s vaccine programs according to Standard Operating Procedures which may exclusively be developed by you. Working in a team and frequently supporting diagnostic development for phase 3 vaccine programs, you will execute and oversee qualification and validation of molecular diagnostic assays and coordinate, as needed, assay lifecycle management activities which many included clinical testing and analysis of control and panel trending over time.
You will use collaborative teamwork to tackle complex projects and challenging timelines. Your skills and expertise will ensure that all work is managed in a compliant manner according to relevant Standard Operating Procedures and cGLP (current Good Laboratory Practice) and/or cGMP (current Good Manufacturing Practices).
You will be recognized as a technical expert in molecular assay development and compliant clinical testing. With your deep knowledge of molecular biology and diagnostic assays, you will regularly contribute molecular diagnostic expertise and can represent the department on multidisciplinary teams. You will be using your scientific acumen to develop molecular diagnostics that address specific project requirements and evaluate new technologies where needed. As an expert in molecular biology, you are expected to supervise junior scientists and guide team member development.
How You Will Achieve It
Lead molecular diagnostic assay development projects and represent the group on multidisciplinary teams.
Leverage a team of analysts to execute project goals and deliver compliant results according to study timelines.
Design experiments to establish assay parameters such as precision, limit of detection, and specificity of molecular diagnostics and validate them for use to support phase 3 trials of vaccines and drug products.
Work collaboratively with numerous groups including statistics, informatics, project management, and clinical testing labs to meet assay development and clinical testing timelines.
Act as single point of accountability for assigned projects, interacting as necessary with stakeholders at all levels of management to convey project information and manage expectations.
Lead both manual and automated molecular diagnostic assay technology transfer to clinical testing groups in cGLP laboratory spaces to maintain efficient high throughput testing and achieve high-quality results.
Provide clear, concise and timely responses to project and/or clinical team requests for experimental information, and guide and develop laboratory-based scientists.
Satisfactorily complete all cGLP training and safety training in conformance with departmental requirements.
Master's degree with 10+ years' experience
Expertise in qPCR, DNA and RNA extraction and manipulation, experimental design, data analysis, and assay validation techniques will be key to this position
Strong experience in laboratory management including inventory and sample tracking, analyst scheduling, oversight of equipment documentation, and regulatory compliance
Breadth of knowledge of different areas of science, awareness of new technologies, and familiarity with current issues to apply novel and innovative approaches to problem solving
Excellent verbal and written communication skills
Proficiency in the use of Word processing, Excel, PowerPoint and relevant scientific software
PhD with 4+ years of relevant experience
Experience with laboratory automation, including Hamilton or open source pipetting robots
Managerial experience, preferably in a regulated environment such as GxP, CLIA, or ISO
Knowledge of next generation sequencing
Complex data analysis
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
May require travel and/or nonstandard work hours to achieve departmental goals
Other Job Details
Eligible for Relocation Package
Eligible for Employee Referral BonusSunshine 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