Why Patients Need YouPfizer'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.Why Patients Need YouPfizer'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.Position Purpose
Hands on and highly independent laboratory activities related to Large Molecule Biotherapeutic bioanalysis. Primary focus is on PK and Immunogenicity (ADA and NAb) assay development, validation and when required sample analysis. Independence in the design, troubleshooting, validation and conduct of the assay to support biotherapeutic programs.
Function as a Bioanalytical Principal Investigator and/or bioanalytical subject matter expert.
With limited support from supervisor, establish Bioanalytical strategy and project support priorities.
Direct or indirect oversight of junior staff to ensure appropriate support is in place and executed. Be a direct resource for junior staff
Responsible for the development of robust and reliable ligand binding assays in non-clinical and clinical biological matrices suitable for characterizing of exposure and immunogenicity of biotherapeutics using a range of potential screening platforms and assay techniques.
Familiarity with cell based platforms, and PCR, LCMS technologies is beneficial
Experience with Automated Liquid Handling equipment for LBA protocols is beneficial
Timely delivery of concentration and immunogenicity data to supervisors and other partners in compliance with local or global regulatory requirement.
Advancing bioanalytical capabilities to improve efficiency, cost effectiveness and appropriateness of assay for regulated support
Development and validation of assays to be governed per departmental SOP.
Ensure GLP and GCP compliance is maintained in laboratory during study support
Influence the advancements of biotherapeutic science externally and internally
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 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 timelines.
As needed, participate in the design, development and implementation of cell-based, PCR and other bioanalytical assays to meet the needs of the portfolio.
Interaction with internal and external groups (CROs) and departments
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
Proactively 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
Experience, Education
MS with at least 10+ year relevant experience
Industry experience with a focus in biotherapeutics development
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.
Hands on skills in GLP/GCP compliant analysis including following SOP and provision of quality regulatory documents.
Excellent communication and presentation skills
PHYSICAL/MENTAL REQUIREMENTS
Sitting, standing, walking, bending, ability to perform mathematical calculations and ability to perform complex data analysis.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Adhere to safe work practices and procedures for a BL2 lab. Wear required PPE.
Work Location Assignment:On PremiseThe annual base salary for this position ranges from $83,500.00 to $139,100.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 10.0% 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 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. This position requires permanent work authorization in the United States.Research and Development