Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients.  Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

The qualified candidate must have the experience and ability to perform microbiological assays within the Quality Science and Technology group. Demonstrates the ability to interpret results and designs/performs microbiological validation assays involving commercial in-process cell culture, purification and bulk drug substance samples, raw materials, and process & cleaning validation samples. Experience with molecular based techniques, including PCR-based assays is a plus. Assays are qualitative, quantitative and investigational in nature and are performed in compliance with USP, FDA and other regulatory body requirements and per standard operating procedures.

How You Will Achieve It

• Performs all work in compliance with cGMPs and site requirements.
• Perform microbiological assays for routine testing and qualification/validation of new methods.
• Support product method improvements, troubleshooting for assays as needed.
• Recognizes atypical or out-of-specifications test results, instrument malfunctions and methodology problems and participates in the investigation to resolve and correct. Support instrument validation activities.
• Accountable for the accuracy and validity of testing results. Reviews and validates data. Interprets results, performs or reviews mathematical calculations, and records observations using Laboratory notebooks or other controlled documentation. Ensures that technical reports are prepared in a timely manner and reviews these reports for technical accuracy and compliance.
• Oversees maintenance of all related records and ensures that laboratory work area is maintained in a neat, orderly, and compliant manner. Suggests continuous improvements to systems, procedures, etc. Carries out technical and administrative duties as needed.

Qualifications

Must-Have

• Bachelor’s degree in Microbiology or related field with a minimum of 2+ years
• Knowledge and practical application of relevant techniques – classical microbiology techniques
• Demonstrated ability to independently document and troubleshoot methods
• Proficiency with Labware LIMS, MS Word and Excel.
• cGMP experience is required

Nice to Have

• Experience with novel rapid microbial technologies such as PCR or rapid bioburden
• Experience with technical writing, such as scientific reports, technical papers, method validation reports, etc.

PHYSICAL/MENTAL REQUIREMENTS

Position is a mixture of lab and office, approximately 50-75% of the time will be spent in the laboratory.  Laboratory duties such as equipment cleaning and maintenance may be required.  Occasional weekend work may be required.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Position is first shift Monday through Friday. Some Holiday and off hour support may be required to support review and/or testing needs.

Work Location Assignment: On Premise

Last Date to Apply: January 31, 2023

Relocation assistance may be available based on business needs and/or eligibility.

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment.  As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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.

Quality Assurance and Control