DSRD In Vivo Technician Specialist - Pfizer
Groton, CT
About the Job
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
DSRD Study Enabling & Execution is a global group composed of subject matter experts in study and project execution, training, compliance and systems, who plays a critical role in the success of DSRD. As a highly valued partner, we focus on the development, empowerment, and leadership of our colleagues to ensure their growth and success.
The In Vivo Technician role functions within study execution and provides non-GLP and GLP in vivo study conduct expertise to advance the Pfizer portfolio, particularly for the selection of new therapeutic candidates but also for support of later stages of clinical development and registration.
The In Vivo Technician is responsible for performing accurate, high quality in-life study work for rodent and non-rodent safety studies in compliance with the study protocol, Standard Operating Procedures (SOPs), Good Laboratory Practice (GLP) regulations, Environmental Health and Safety (EHS) standards, animal welfare regulations, and departmental policies/procedures. The data collected on these studies by the In Vivo Technician enable candidate selection, first-in-human studies, 13-week or longer studies and early research and target safety and investigative work.
As part of the Technical Operations team, your prior work experience and ability to apply your breadth of knowledge will help you adapt the standard methods and procedures. You will help us identify required delivery and process improvements that drive increased efficiency, throughput and quality. You will arrive at decisions on which methods and procedures are the best fit for different work situations.
It is your hard work and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
- Manage own time, professional development, and accountable for own results.
- Prioritize own workflow and assist in prioritizing the work flow of less-experienced colleagues.
- Participate in functions involving teams which impact production, increase efficiency, solve problems, generate cost savings and improve quality.
- Compare laboratory results with specifications for acceptability and determine if repetition or Out of Stock is required.
- Follow procedures at all times, adopting {Current} Good Manufacturing Practices {part of GxP} and cGDP practices.
- Consistently adhere to company, site, and laboratory safety rules and immediately raises any safety issues with supervision as soon as they are identified.
- Generate valid data and reports results in appropriate database.
- Calculate results and compares to specification limits.
- Complete all testing including special project/ protocol testing in a timely and appropriate manner.
- Report testing results through computerized systems, or through standard laboratory paper-based documentation.
- Performs all regulatory responsibilities in compliance with applicable regulatory standards.
- Responsible for performing all aspects of the in-life phase of rodent and non-rodent safety studies including study set up, test article administration, animal observation, sample collection, data collection and documentation, data quality control review, and preparation of in-life data for archiving.
- Read, understand and follow the study protocol and understand connection between study protocol and the electronic data capture system protocol which is based on the study protocol.
- Serve as Lead Study Technician for studies independently with minimal to no supervision.
- Manage multiple assignments/projects simultaneously while maintaining data quality and meeting timelines.
- Ensure proper supplies and equipment are available and suitable for study conduct functions; generate forms, labels, and other materials needed for study conduct as required.
- Responsible for use, maintenance and calibration of equipment, e.g. balances, centrifuges.
- Troubleshoot and solve equipment/technical problems associated with in life study conduct.
- Communicate with Management, Study Director, Comparative Medicine and support personnel to ensure compliance with all protocol driven activities, high quality animal welfare practices are followed, and to enable proactive adjustment of the protocol by the Study Director in the event of unexpected events or findings.
- Completes self-review of in-life data for accuracy and completeness against the protocol; appropriately documents and corrects data errors, notifies appropriate study personnel as required.
- Completes QC review of in-life data collected by others depending on experience and level.
- Assist in preparing data for QA audits and addressing and drafting responses depending on level and experience.
- Adheres to all applicable company and unit policies and procedures. · Ensures work areas are kept clean and orderly. · Meets established timelines for deliverables.
- Reviews and recommends updates for departmental SOPs, may draft updates to SOPs depending on experience and level.
- Participates in a culture of continuous improvement within assigned work group.
- Other activities as delegated by Study Director or Test Facility Management.
Qualifications
BASIC QUALIFICATIONS
High school with >7 years applicable experience (i.e., veterinarian care, laboratory animal care and handling); or
Associates Degree, Biological Sciences (or equivalent) with >3 years applicable experience; or
B.S., Biological Sciences (or equivalent) with 0-2 years applicable experience
PREFERRED QUALIFICATIONS
>10 yrs of relevant in vivo toxicology study conduct experience
A.S., Biological Sciences (or equivalent) with >5 yrs of relevant in vivo toxicology study conduct experience
B.S., Biological Sciences (or equivalent) with >2 yrs of relevant in vivo toxicology study conduct experience
AALAS Certification
GxP experience
PHYSICAL/MENTAL REQUIREMENTS
- The position requires performing in vivo work (working directly with laboratory animals) and therefore the colleagues must be able to wear appropriate PPE and physically perform the technical procedures. In addition, this position requires the entry into nonhuman primate areas as part of their job responsibilities. A pre-hire requirement is either providing proof of measles immunity or receiving the measles vaccination before hire.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Weekend/holiday work will be required.
Other Job Details:
- Last Date to Apply for Job: 28 JUNE 2024
- Eligible for Employee Referral Bonus
Work Location Assignment: On Premise
On Premise colleagues work in a Pfizer site because it’s needed to get their job done. They may have flexibility to work remotely from time to time, but they are primarily on-site.
The salary for this position ranges from $31.82 to $53.04 per hour. In addition, this position offers eligibility for overtime, weekend, holiday and other pay premiums depending on the work schedule and the Company’s policies. 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 applies only to the United States - Connecticut - Groton location.
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.
Research and Development