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Microbial Control Strategy Manager


Sanford, NC
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Job Details


The Microbial Control Strategy Manager owns the Microbial Control Strategy for the Site and provides direction to adhoc members from ancillary groups on the Microbial control team, with accountability to deliver the Microbial Control Strategy. This includes establishment of microbial control standards for each element of the strategy (Personnel, Facilities/Utilities, Environment, Materials, Process) and oversight to ensure standards are met and re-evaluated over time to ensure appropriateness. The Microbial Control Strategy Manager will ensure the program is monitored through performance metrics and drives the appropriate action.


+ Provides leadership to the Site in the areas of microbial control. This includes collaborating with the all functions across the Site and within the Network. Represents the Site's Microbial Control Strategy with internal and external auditors.

+ Capable and experienced excellent decision maker who includes global Pfizer impact awareness on future quality and compliance thinking as a part of decisions for microbial control.

+ Capable of metric setting, tracking, trending, evaluating, and drawing conclusions for improvements and actions, and reporting for the Quality Operations, site, and/or Network for issues related to microbial control.

+ Lead forum(s) within Sanford and participate or lead as applicable across Quality Biotech to identify and champion technical programs/projects related to improving microbial control through methods, laboratory operations, new technologies and emerging regulatory trends.

+ Assist the commercial and clinical operations to maintain compliance in microbial control in terms of Pfizer Standards, FDA requirements and Global Regulatory requirements, company policies, procedures and all other applicable regulations and guidelines.

+ Liase with the commercial manufacturing department, QC microbiology laboratory, MSAT, and the PharmSci manufacturing organization regarding PGS standards and requirements regarding microbial control, including the optimization, validation and transfer of methods improving microbial control for new and marketed products, intermediates, and raw materials.

+ Provide microbiological knowledge to support development activities, special projects, investigations and methods involving advanced technology for microbial control.

+ Proven excellent and consistently used leadership soft skills


Education and Experience:

+ 10 or greater years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a BS/BA Degree in Science/related field

+ 7 -8 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a MS Degree in Science/related field

+ 2 -4 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a Ph. D in Science/related field

+ Familiarity and experience with mammalian cell culture, bacterial fermentation, protein purification and/or solution formulation are highly desirable and may be a differentiator between candidates.

+ Previous experience in a GMP manufacturing environment required.

+ Demonstrated prior experience in Project Management and indirect people management preferred.

+ Experience/certification in Six Sigma, Method 1, 5S and/or other operational excellence programs desirable. Green belt certification optimal.


+ Sitting, standing, walking - including gowning and working within classified areas.


Some weekend and off shift work may be required.

**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.

**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.

+ **Last Date to Apply for Job: 6 December, 2017**

+ **This job is (Pfizer) (Exempt) role**

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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