Cell-Based QC Scientist II

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.

You will be a member of Pfizer’s dedicated and highly effective quality assurance and control team. You will be responsible for analyzing chemical, biological or microbiological products to support our quality programs. Your contribution to environmental testing, utility monitoring, analytical testing, microbial identification and sterility testing will help Pfizer provide safe drugs to patients.

Your understanding of Quality Control instruments will help us meet their accuracy specifications against established standards. You will also be relied on for setting requirements for the transfer of methodology from R&D.

As a Senior Associate scientist, your significant experience of applying knowledge of principles, concepts, and practices of the discipline will make you a critical member of the team. Your skill and knowledge will help in making decisions that require choosing among limited options. Your being proactive in team discussions will help in creating an environment of collaboration.

It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

The qualified candidate will provide support for analytical method testing in a cGMP quality control analytical (QCA) laboratory.  This includes analytical testing support for multiple products including plasmid DNA, vaccines, mAbs, and proteins. The testing includes various techniques including Cell Culture, Bioassay, UV spectrophotometry, and ELISA methods. This position requires working collaboratively with the QCA team and actively participating in scheduling, visual management, metrics, and continuous improvement activities.

• Perform and support lab testing of in process, release and stability samples:  execute testing, review data and documents for compliance and accuracy.   Support laboratory investigations 
• Maintain all related data and records in compliance with cGMPs and quality procedures
• Perform laboratory support functions and maintain work area in compliance with cGMP and quality procedures.
• Collaborate with site functional areas and customers to support site goals and objectives and transfer timelines. 
• Meet all timelines and deliverables in support of mRNA manufacturing.
• Support assay troubleshooting and look for CI opportunities/method improvements. Identify technical issues, atypical or out-of-specifications test results, instrument malfunctions and methodology problems and participates in the investigation to resolve and correct.

• B.S. in Biology, Chemistry or related scientific discipline
• 3 + years of applicable laboratory experience
• Experience in cell culture, bioassay, aseptic techniques and ELISA and practical application of relevant analytical techniques including troubleshooting
• Experienced in cGMP environment
• Proficiency with computer systems (Microsoft Office applications, LIMS, etc.). 
• Excellent communication skills both oral and written. 

• Strong understanding of continuous improvement tools and skills preferred (standard work, visual management, DMAIC)

PHYSICAL/MENTAL REQUIREMENTS

Normal lifting, sitting, standing and walking requirements to facilitate support of staff in the office and on the floor (laboratory, suites, etc.). 

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Position is first shift Monday through Friday.  Some off hour (night/weekend/holiday) support may be required to support staff and operations

Relocation support available

Last Date to Apply: September 26 2022

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.