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 Quality Control Microbiology department is seeking a highly motivated candidate to support GMP QC Microbiology Laboratory at the Sanford North site.  The position is responsible for the leadership and oversight of the Quality Control Microbiology team.  The QC Microbiology Manager provides leadership and knowledge in collaboration efforts with other team leaders to provide microbial expertise for the Sanford North Facility.  The Manager, QC Microbiology is responsible for the daily management of the Microbiology associates and QC Microbiology performance of microbiological testing (bioburden, endotoxin, environmental monitoring, gas testing, sterility testing microbial identification, TOC and conductivity) for batch release.  The successful candidate will be team oriented, have a “right the first time” attitude, detailed oriented, exhibit equity and inclusiveness, and take initiative.

You will be a member of Pfizer’s dedicated and highly effective quality control team. You will be responsible for analyzing 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 (QC) 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 Research and Development (R&D).

As a Manager, your breadth of knowledge on internal or external business challenges will help us improve our products, processes and services. Your will guide us to lead projects by meeting objectives and preparing forecasts for resource requirements. Your risk-taking ability will help us advance new concepts and methodologies. You will provide technical guidance and oversight to team members and help in problem solving.

How You Will Achieve It

• Manage multiple projects and ongoing work activities of moderate complexity within the division typically involving cross-functional representatives.

• Oversee and guide lab analysts on continuous improvement tools such as standard work and visual management.

• Review and approve documentation associated with Good Manufacturing Practices {also cGMP}, method validation, investigation of change controls and technical reports.

• Collaborate with site functional areas and customers to support site goals, objectives and timelines.

• Ensure alignment to all regulations and Pfizer Quality Standards related to area of oversight and work with other management teams to ensure support for all testing activities in the routine testing area.

• Provide oversight of Microbiology product testing group responsible for routine testing of product or process samples for endotoxin and bioburden.

• Oversee project management of all Data Integrity related activities with the relevant teams.

• Address and resolve any potential issues with regulatory impact.

• Develop and maintain alignment with current industry best practice related to cleanroom techniques and share with the respective teams.

• Represent area of responsibility at meetings and in audits.

• Provide information, discuss problem batches, manufacturing/technical issues, deviations and other events with potential impact on product quality and/or supply.

• Foster teamwork and colleague development, as well as change management, within the department and set up departmental metrics to achieve operation effectiveness.

• Lead and Perform routine, non-routine environmental monitoring (EM) of the GMP manufacturing facilities for total particulates, air viables, and surface viables.

• Initiate and participate in the investigations of EM excursions and assess any potential impact on product quality.

• Assist in trending EM data and generate quarterly reports and yearly reports.

• Perform analysis and data analysis of in-process samples, APIs, and stability samples using existing methods.

• Support assay transfer, qualification, and validation activities for client’s specific methods.

• Maintain QC lab equipment and provide assistance, as needed, during equipment and facility qualification activities.

• Interact closely with other departments to ensure efficient, compliant and timely execution of project activities.

• Provide assistance as needed to maintain functioning QC Laboratory, including material ordering, inventory control, general housekeeping and other duties.

• Assist in investigation and review of GMP quality events, including but not limited to deviations, out of specification reports, and audit findings.

• Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results with a customer driven focus.

• Safely operate laboratory equipment in accordance with established practices.
   

Qualifications

Must-Have

• HS or GED with 10+ years of experience in a GMP microbiology laboratory, environmental monitoring in a GMP environment and 5+ years of managerial experience, OR

• AS degree in Biology, or related Life Sciences with 8+ years of experience in a GMP microbiology laboratory, environmental monitoring in a GMP environment and 3+ years of managerial experience, OR

• BS degree in Biology, or related Life Sciences with 5+ years of experience in a GMP microbiology laboratory, environmental monitoring in a GMP environment and 2+ years of managerial experience, OR

• MS degree in Biology, or related Life Sciences with 3+ years of experience in a GMP microbiology laboratory, environmental monitoring in a GMP environment and 2+ years of managerial experience, OR

• Work to the highest degree of ethical and moral standards

• Abide by Pfizer’s quality standards set by regulations, policies and procedures

• Be able to communicate effectively with subordinates, colleagues and supervisors

• Ability to participate effectively as a team player in all aspects of Pfizer business

• Demonstrated experience in Quality Control

• Extensive knowledge of Good Manufacturing Practices {also cGMP} compliance requirements for Quality Control Laboratories, application of compendial methods and experience with a wide range of analytical techniques

• In-depth understanding of aseptic processing and monitoring procedures

• Experience with one or more of the methods such as: bioburden, endotoxin, total organic carbon, conductivity, sterility testing, microbial identification

• Ability to gown for and work in a cleanroom environment

• Experience and knowledge of GMP, following standard test methods.

• Reasoning ability including strong analytical and problem solving abilities

• Ability to use routine laboratory equipment including, but not limited to, particle counters, air samplers, microscopes, etc.

• Review analytical test results.

• Strong people management experience

• Strong verbal and written communication skills

• Stand in for Senior QC Manager as needed.

• Ability to represent and support QC Microbiology in audits.

• Train associates on microbial testing, etc.

• Lead, coach, and develop QC Microbiology associates.

• Ensure safe work environment for the Microbiology team.

Nice-to-Have

• Knowledge in the application of statistical tools, root cause analysis and/or six sigma methodologies.

• In depth understanding and experience of Microbiology testing

• Technical Writing

• Experience with LIMS

• Preferred knowledge in environmental excursion investigations, root cause analysis, and/or knowledge of cleanroom practices

• Project Management

• Experience with instrument validations

• Able to troubleshoot instrumentation

• Ability to work well under pressure, multi-task, and have good organizational and communication skills

Physical / Mental requirements

• Able to stand 1-2 hours at a time, sit for 2-3 hours at a time

• Frequently lift and/or move objects up to 30 pounds

• Walk/stand during entire length of shift

• Ability to successfully gown in a GMP clean room environment without compromising the integrity of the gown.

• Use of arms, fingers and hands to feel and reach

• Ability to crawl, crouch, kneel, stoop, balance and climb

• Ability to see near and far, color, peripheral vision, depth and the ability to focus

Non-Standard work schedule, travel or environment requirements

• Shift B Schedule - Wed - Sat 6:30am-5pm

Other job details

• Last day to apply: June 22nd, 2023

• Employee Referral Bonus eligible

Work Location Assignment: On Premise

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