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Job Description
- Req#: 4913121
- Performs all regulatory responsibilities in compliance with applicable regulatory standards
- Performs all aspects of the preparation of dosing formulations including mathematical calculations for routine preparations (eg, API, volume), review of study protocols for routine formulations, analytical sample collection, data collection and documentation, data self-review, and preparation of in-life data for archiving. Task complexity may increase based on experience
- Reads, understands and follows the study protocol
- Serve as Primary Formulation Technician for studies depending on level and experience
- Manages multiple assignments/projects simultaneously while maintaining data quality and meeting timelinesEnsures proper supplies and equipment are available and suitable for formulation functions; generates forms, labels, and other materials needed for formulation preparations as required
- Responsible for use, maintenance and calibration of equipment, e.g. balances, mixers
- Troubleshoots and solves equipment/technical problems associated with formulation preparation, dependent on level and experience
- May perform tasks associated with the pharmacy and API ordering
- Conducts review of own work contributing to Out of Specification (OOS) investigations and, with appropriate experience, may lead OOS investigations
- Communicates with Management, Study Directors, Study Technicians and support personnel to ensure compliance with all protocol driven activities, and to enable proactive adjustment of the protocol by the Study Director in the event of unexpected events or findings
- Completes self-review of formulation data for accuracy and completeness against the protocol and SOP’s; appropriately documents and corrects data errors, notifies appropriate study personnel as required
- May complete QC review of formulation data collected by others
- Assists in preparing data for QA audits and addressing and drafting responses, depending on level and experience
- Prepares and/or submits formulation data for archiving
- 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
- Takes on leadership responsibilities, including but not limited to, providing scientific expertise to the group for site interactions (T04)
- Conducts complex Out of Specification (OOS) investigations (T04)
- Solves complex problems with limited supervision (T04)
- Other activities as delegated by Study Director or Test Facility Management
- BS in chemistry, pharmacy, biology, or related field with 0-2 years GLP experience; or
- Associates Degree in chemistry, biology, or veterinary technology with 2-5 years related experience; or
- High school diploma (US) with a minimum 5 years of related experience
- Experience performing formulation preparations for in vivo studies in a GLP environment preferred.
- Use of electronic data capture systems, spreadsheet applications or other data management systems preferred.
- Last Day to Apply: July 1st, 2024
- Work Location Assignment: On Premise
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.
Position Summary
The Formulation Technician is responsible for performing accurate, high quality formulation work for in vivo studies in compliance with the study protocol, Standard Operating Procedures (SOPs), Environmental Health and Safety (EHS) standards, Good Laboratory Practice (GLP), and any other applicable regulatory standards and departmental policies/procedures. The formulations prepared by the Formulation Technician are used for in vivo studies conducted in support of the Portfolio, including early research and target safety and investigative work.
Position Responsibilities
Overtime, weekend and holiday work may be required
Qualifications
PHYSICAL/MENTAL REQUIREMENTS
Requires occasional lifting of up to 45 lbs, extended periods of time sitting and working under a hood.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
None
OTHER JOB DETAILS:
The salary for this position ranges from $28.68 to $47.79 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.
Research and DevelopmentEEO & 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.
About the company
At Pfizer we know that great things happen anywhere people come together with one shared goal. And the greatest rewards are sometimes where you least expect them. The future of medicine is happening at Pfizer.
Notice
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