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Gene Therapy Principal Operations Specialist


Sanford, NC
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Job Details

Job Title Gene Therapy Principal Operations Specialist

JobID 1613455

Location: Sanford, NC

Description **ROLE SUMMARY**

The Principal Operations Specialist works as part of a team to execute batch activities and serves as an operations and technical expert and improvement champion in on or more of the following areas:

• Aseptic Processing

• Cell Culture / Viral Manufacturing

• Formulation / Filling

• Labeling / Packaging

• Manufacturing and Quality Systems

• Operator Care / Equipment Operations

• Automation

• Manufacturing Technologies

The incumbent is expected to have the scientific/engineering acumen to execute and support batch activities across all areas and all products. In addition, the incumbent will be responsible for process/equipment troubleshooting and problem solving on the floor.

The Principal Operations Specialist will develop the capability of other Operations Specialists by sharing their knowledge and and expertise and coaching them on ways to reduce waste and variability. In addition the Principal Operations Specialist will have responsibility for leading and closing investigations on time and implementing associated CAPA, completing quality systems commitments, and managing change in the area.

The incumbant must role model leadership behaviors and be capable of filling in for the Operations Manager.

The incumbent is expected to maintain GMP documentation and documenting the manufacture of clinical material. The incumbent must comply with applicable safety, occupational health, loss prevention and environmental requirements.


1. Execute clinical production on-time and without injury or defects.

2. Develop Operations Specialists knowledge and skillset in areas of personal expertise

3. Maintain inspection readiness of area

4. Own area change controls and commitments

5. Proactively implement improvements to business and manufacturing processes that improve flexibility, eliminate waste, and reduce variability.

6. Ensure that all documentation aheres to documentation model standard. Maintain the accuracy of all documentation needed for operations including SOPs, batch records and compounding records.

7. Implement 5S, standard work, visual management, special cause and common cause problem solving in area.

8. Role model OWNIT! behaviors

9. Partner with EHS to build processes, tools, and mindsets that ensure a zero injury workplace.

10. Author and approve quality and safety investigations and implementation of CAPA.

11. Execute a robust operator care program.


+ Grade 10: A minimum of a BS degree + 10 years of experience; MS + 10 years of experience in any of the following disciplines: Chemistry, Biochemistry, Biotechnology, Chemical Engineering, Chemistry, Microbioogy or equivalent science related or engineering 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.

**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: 21 September, 2017**

+ **This job is (Pfizer) (Exempt) (US/PR) Grade: 010**

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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