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Sr Development
2 months ago
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 Senior Associate 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 assist with development and qualification of bioanalytical methods in support of characterization, toxicology and stability studies for bioprocess and formulation development of early phase vaccines.
Your significant experience of applying knowledge of principles, concepts, and practices of the discipline will make you a critical member of the team. You are proactive in contributing to all team discussions and creating an environment of collaboration.
It is your innovative scientific temperament that will help in making Pfizer ready to achieve new milestones and help patients across the globe.
The Regulated Clinical Biomarker/Flow Cytometry group works with clinical and translational teams across Pfizer research units to develop and implement complex flow cytometry-based biomarker assays and supportive translational/mechanistic studies for early phase clinical projects in a GCLP environment. This position is responsible for supporting scientific research and/or scientific strategies in a biomarker/biomeasure focused flow cytometry laboratory. This senior associate scientist will provide technical and scientific support for biomarker data using flow cytometry (FACS), cell imaging and related technologies for both non-regulated and regulated clinical biomarker studies supporting Pfizer drug candidates.
How You Will Achieve It
Responsible for supporting clinical flow cytometry biomarker assay development and validation, data generation and analysis, QC and data interpretation.
This position will participate with BEST/CBT teams in a matrix environment. The person will have growing knowledge in the development of flow cytometry and cell imaging-based biomarkers/biomeasures to enable Pfizer discovery and development objectives.
This role will participate in all phases of FACS laboratory operations including technology evaluations, the development of sample preparation, separation and detection methods, data analysis and interpretation.
All colleagues in this role are responsible for maintaining regulatory compliance appropriate for clinical study execution including all proscribed training as found in CBT SOPs and training transcripts. This includes knowledge, training and understanding of GLP/GCP guidance for execution of preclinical and clinical studies supporting Pfizer portfolio projects, as applicable.
Participate in continuous improvement of scientific and regulatory processes via updating/creation of SOPs, implementation of laboratory based processes, and development of best practices for bioanalytical data generation.
Responsible for QC and peer review of raw data, results, and final reports from other collegues within the regulated group (depending on level of training). Additionally responsible for participation in internal and external audits providing required information to auditors as needed.
May also participate/respond to internal audit findings on assigned projects.
Occasional weekend work for processing clinical samples should be anticipated.
Qualifications
Must-Have
Bachelor's Degree or equivalent experience in chemistry, biochemistry, biology or related discipline with over 3-5 years of experience in drug development and regulatory compliance within the pharmaceutical industry
Master's Degree with 0 to 3 years of experience in drug development and regulatory compliance within the pharmaceutical industry
Experience in immune cell function and phenotypic analysis using a variety of assays.
Knowledge and experience of global regulatory requirements as well as industry guidance as they relate to GCLP.
Excellent oral and written communication skills.
Ability to deal with project and organizational changes while supporting the organization
Nice-to-Have
Industry experience with a focus in biotherapeutics
Good understanding or experience in the Quality Control review of work conducted in a regulated laboratory
PHYSICAL/MENTAL REQUIREMENTS
Ability to lift 50 pounds.
Strong communication skills.
Critical thinking skills.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Occasional weekend work.
Work Location Assignment:On Premise
The annual base salary for this position ranges from $64,600.00 to $107, In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 7.5% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | ). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
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. This position requires permanent work authorization in the United States.
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