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Manager, QC Microbiology

Pfizer


Location:
Andover, MA
Date:
09/22/2017
2017-09-222017-10-21
Job Code:
1609671
Pfizer
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Job Details

Job Title Manager, QC Microbiology

JobID 1609671

Location: Andover, MA

Description Lead major aspects of QC Microbiology clinical/commercial lab testing in the following areas through all levels of personnel as direct reports -such as in-process/drug substance and raw material microbial detection, endotoxin, mycoplasma; MMV, microbial identification, facility/utility and water environmental monitoring (sample collection and testing) as well as cleaning validation/verification and change over and TOC; method validation/verification, method development, method transfer, process validation support, investigational support. Primary responsibility managing Product Testing group and provide support for Non-product Testing and Non-Testing group as needed (back up for other management). Oversee investigations, data reporting and trending in support of Andover clinical/commercial drug substance manufacturing. May oversee testing conducted by contract laboratories. Provide departmental subject matter expertise to Pfizer corporate initiatives and contract manufacturing sites. Responsible for planning and scheduling aligned with company goals.



+ **ROLE SUMMARY**

+ Lead major aspects of QC Microbiology clinical/commercial lab testing in the following areas through all levels of personnel as direct reports -such as in-process/drug substance and raw material microbial detection, endotoxin, mycoplasma; MMV, microbial identification, facility/utility and water environmental monitoring (sample collection and testing) as well as cleaning validation/verification and change over and TOC; method validation/verification, method development, method transfer, process validation support, investigational support. Primary responsibility managing Product Testing group and provide support for Non-product Testing and Non-Testing group as needed (back up for other management). Oversee investigations, data reporting and trending in support of Andover clinical/commercial drug substance manufacturing. May oversee testing conducted by contract laboratories. Provide departmental subject matter expertise to Pfizer corporate initiatives and contract manufacturing sites. Responsible for planning and scheduling aligned with company goals

+ Oversight of QC Microbiology functions primarily include routine testing of product/process samples for endotoxin and bioburden. Responsible for planning and scheduling aligned with company goals.

+ Provide leadership/direction to staff, and responsible for performance management and growth and development of staff.

+ Responsible for working with managers overseeing other areas (non-product testing, microbial science and technology, non-testing/lab compliance). Be able to provide support to staff in other areas as needed.

+ Oversee investigations, data reporting and trending and driving continuous improvement in laboratory processes.

+ Provide departmental subject matter expertise to Pfizer corporate initiatives.

+ Represents QC Microbiology at various meetings.

+ Minimum B.S. in Microbiology or related scientific discipline with 10+ years experience in a GMP regulated QC Microbiology laboratory and a minimum of 2 years of management experienceM.S. in Microbiology with a 6-8 years of experience in a GMP regulated QC Microbiology laboratory and a minimum of 2 years of management experience.PhD in Microbiology with a 4-6 years of experience in a GMP regulated QC Microbiology laboratory and a minimum of 2 years of management experience.Demonstrated applied microbial knowledge in support product release testing, contaminations and investigations. Experience with microbiological risk assessments preferred. Experience with PCR based methods (e.g. mycoplasma and virus testing) a plus.

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



**EEO Statement**

**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.



**Additional Offer Details:**



+ **Last Date to Apply for Job: August 29, 2017**

+ **Grade: 10**



A career at Pfizer offers opportunity, ownership and impact.



All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.



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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