Formulation Technician

ROLE 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.

ROLE RESPONSIBILITIES

• 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.
• Tasks and complexity increasing as experience and knowledge is gained.
• 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 timelines.
• Ensures 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 as experience is gained 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.
• As experience is gained, may complete peer 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 formulation data for archiving and may be responsible for archival of data.
• 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.

How You Will Achieve It

• Manage own time, professional development, meets established timelines for deliverables and takes accountable for own results.
• Perform all regulatory responsibilities in compliance with applicable regulatory standards.
• Ensure proper supplies and equipment are available and suitable for study conduct functions.
• Communicate with Management, Study Director, 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.
• Responsible for use, maintenance and calibration of equipment, e.g. balances, centrifuges.
• Generate forms, labels, and other materials needed for formulation preparations as required.
• Read, understand and follow the study protocol and understand connection between study.
• Ensures work areas are kept clean and orderly.

Qualifications

Must-Have

• 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.
• Maintains a positive work atmosphere.
• Strong organizational and time management skills and detail oriented.
• Strong interpersonal and communication skills.

Nice-to-Have

• Experience performing formulation preparations for in vivo studies in a GLP environment.
• Use of electronic data capture systems, spreadsheet applications or other data management systems.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Ability to work overtime, travel or adhere to safe work practices

Other Job Details:

• Last Date to Apply for Job: February 26, 2021
• Eligible for Employee Referral Bonus: YES

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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.

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