10 days old

Gene Therapy Operations Specialist I

Sanford, NC 27330
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**Why Patients Need You**

Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer's mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.

**What You Will Achieve**

The Gene Therapy Operations Specialist I 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 will be responsible for performing GMP activities in the purification area, but is expected to have the flexibility, if required, to learn and perform operations across multiple areas (cell culture, solution prep, formulation/fill, pack/label) and products. In addition to operating equipment the operations specialist will be responsible for:

+ Completing GMP documentation

+ Managing inventory levels and completing materials transactions in electronic systems

+ Performing operator care activities

+ Identifying ways to improve work and implementing solutions

+ Participating in investigations

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

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

**How You Will Achieve It**

+ Execute batch activities on-time and without injury or defect

+ Manage assigned projects and ongoing work activities within a team

+ Execute assigned activities associated with the Operator care program

+ Monitor the status of training and complete all required training prior to performing associated tasks

+ Ensure (Current) Good Manufacturing Practices (part of GxP) compliance and assist in validation protocols as required

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

+ Meet area performance measures in areas such as safety, quality, and productivity

+ Maintain the accuracy of all documentation needed for operations, including Standard Operating Procedures and batch records

+ Must be capable of performing data entry into calculators and computers.

+ Role model Pfizer values

+ Execute and sustain the components of the lean management system



+ A minimum of 0 - 2 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 2 - 4 years experience with a 2 year associates degree in a science-related discipline.

+ Strong interpersonal skills, solid skills in mathematics, communications, and organization

+ Able to read and write, as well as, follow written and oral instructions


+ Hands-on experience with purification operations such as column chromatography, filtration, and ultrafiltration/diafiltration are desired

+ Strong background in Good Manufacturing Practices {also see cGMP} compliance and working knowledge of System Application and Products

**Organizational Relationships**

+ Role will interact daily with all members of their team and with cross functional teams as required

**Training Requirements**

+ Training requirements for the incumbent include all site safety and GMP ESSENTIAL training curricula as well as job specific GMP curricula aligned to the role.


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.

**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: 2021-06-04 Expires: 2021-07-05
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Gene Therapy Operations Specialist I

Sanford, NC 27330

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