1+ months

Gene Therapy Operations Specialist II

Sanford, NC 27330
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The Gene Therapy Operations Specialist works as part of a team to execute batch activities in a new state of the art gene therapy manufacturing facility in Sanford, NC. The incumbent is will be responsible for performing GMP activities in an assigned area, but is expected to have the flexibility to perform operations across multiple areas (cell culture, purification, solution prep, formulation/fill, pack/label) and products. In addition to operating equipment the operations specialist will be responsible for:

+ Completing GMP documentation

+ Performing operator care activities

+ Identifying ways to improve work and implementing solutions

+ Leading and participating in investigations that address increasingly more complex issues

In addition, the operations specialist will be assigned as a team member on cross functional teams and be given project assignment to develop problem solving, technical expertise, and leadership capability.

The Operations Specialist has demonstrated an ability to troubleshoot equipment and automation related issues on the floor and to manage multiple project assignments while balancing primary responsibility of executing batch activities.

The incumbent must also comply with applicable safety, occupational health, loss prevention and environmental requirements.


Execute batch activities on-time and without injury or defect. Troubleshoot equipment and automation issues. Monitor the status of training and complete all required training prior to performing associated tasks. Update and maintain information in manufacturing support systems used for planning, variance tracking, and continuous improvement. Proactively implement improvements to business and manufacturing processes that improve flexibility, eliminate waste, and reduce variability. Maintain the accuracy of all documentation needed for operations including SOPs, batch records and compounding records. Execute and sustain the components of the lean management system such as 5S, standard work, and visual management. Role model Pfizer behaviors. Perform pre-task safety checks and demonstrate commitment to developing and maintain a safe workplace. Execute assigned activities associated with the operator care program.


2 - 4 years experience in biotech operations with a BS degree in any of the following disciplines: Chemistry, Biochemistry, Biotechnology, Chemical Engineering, Chemistry, Microbiology or equivalent science related or engineering discipline.

A minimum 5 - 7 years experience with a 2 year associated degree in a science-related discipline.


Some standing, ladder climbing, bending, pushing and lifting (up to 40 lbs.) may be required on a daily basis when the colleague is supporting work in manufacturing. Other job functions require working in an office setting where sitting and computer usage would be the norm.


It may be necessary to work shifts according to the manufacturing schedules.

+ **Last Date to Apply for Job:** **5 /13/2020**

+ Eligible for Employee Referral Bonus

**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.

Posted: 2020-04-30 Expires: 2020-08-02
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Gene Therapy Operations Specialist II

Sanford, NC 27330

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