Scientist PDM Bioanalytical
Job Description
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
Worldwide Research and Development (WRD) at Pfizer combines research and technology units that have deep disease area expertise and cutting-edge science and platforms to discover and develop innovative therapeutic programs in small molecules and biotherapeutics, including vaccines.
As a 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 be recognized as a technical expert and a scientific contributor. With your deep knowledge of the discipline, you will be an active team member who influences at the project team level. You will be using your scientific judgment to adapt standard methods and techniques by applying prior work experience and consulting others. Your ability to plan will help in preparing short-term work activities on projects. Your creativity in developing novel processes and new ideas will be used frequently. You will undertake mentoring activities to guide your team members.It is your hard work and dedication that will make Pfizer ready to achieve new milestones and help patients across the globe.
Position Purpose
Work under the guidance of a supervisor on the activities below
Hands on and highly independent laboratory activities related to Large Molecule Biotherapeutic bioanalysis with a focus on development and validation of PK and Immumogenicity (ADA and NAb) assays
Responsible for the development of robust and reliable ligand binding assays (LBA) in non-clinical and clinical biological matrices suitable for characterization of exposure and immunogenicity of biotherapeutics using a range of potential screening platforms (e.g., MSD, ELISA, and/or Gyros) and assay techniques
Responsible for assay validations and conduct of the assays to support biotherapeutic programs by following departmental SOPs
Familiarity with cell-based assays, or PCR, or LCMS technologies is a plus
Familiarity with automated liquid handling platforms is a plus
Advancing bioanalytical capabilities to improve efficiency, cost effectiveness and appropriateness of assay for regulated support
Timely delivery of concentration and immunogenicity data to supervisors and other partners in compliance with local or global regulatory requirement
Ensure GLP and GCP compliance is maintained in laboratory during study support
Responsible for providing appropriate documentation to ensure highest compliance level as the supported bioanalytical work includes regulated non-clinical and clinical phase
Primary Responsibilities
Laboratory focused non PhD position
Design, develop and implement ligand binding assays (e.g. ELISA, ECL, Gyrolab 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 platforms in a regulated (GLP, GCP) environment against challenging time lines
As needed, participate in the design, development and implementation of cell-based, PCR and other bioanaytical assays to meet the needs of the portfolio
Perform data analysis and interpretation and be able to draw conclusions regarding progress and results of work, utilizing the data in appropriate decision making
Analytical problem solving
Gather input from literature, colleagues and additional resources to assist in driving projects forward
Work in a matrix, team environment and demonstrate flexibility and change agility
Qualifications
Experience, Education:
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
Industry experience with a focus in biotherapeutics and a strong record of scientific achievement; excellent communication skills
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
Excellent communication and presentation skills
The annual base salary for this position ranges from $74,900.00 to $124,800.00. 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 | (uscandidates.mypfizerbenefits.com). 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.
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.
