3 days old

Upstream Process Engineer, Gene Therapy Manufacturing Technical Services

Pfizer
Sanford, NC 27330
**ROLE SUMMARY**

As a member of the Gene and Cell therapy Technical Support Team located in Sanford, NC, the Upstream Process Engineer will play a pivotal role in the design, start-up, and verification of the Stage 2 GTx manufacturing and pilot plant facilities in Sanford, NC. The incumbent will review and approve user requirements and design specifications, support fit for use activities (FAT, commissioning, verification), and serve as an Upstream process subject matter expert.

During the initial phase this role will focus on supporting the Gene Therapy facility start-up, process transfers and process validation. Following execution of process validation the scope of work will include process performance monitoring, support for change controls and deviations as well as identification of process improvements.



**ROLE RESPONSIBILITIES**



+ Actively contribute to design of GTx commercial upstream equipment, design, and verification activities

+ Partner with current team to ensure consistency between upstream unit operations between Stage 1 and Stage 2 processes

+ Designs technical and engineering studies, writes technical reports summarizing study results, and generates necessary data to support change impact assessments during process transfers and investigations.

+ Authors process and equipment descriptions, process flow diagrams and risks assessments.

+ Supports change management and implementation for changes to the manufacturing processes and associated systems. Owns change controls related to process changes.

+ Identifies potential process improvements projects. Leads implementation of process improvements projects and supports compliance driven projects that require technical support.

+ Supports process transfers to the Sanford Gene Therapy facility.

+ Author and contribute to the Upstream process validation plans, protocols, and reports.

+ Benchmark and monitor process performance using statistical tools



**QUALIFICATIONS**

**Required**



+ Master or BS in Bioprocessing, Biomedical Engineering, Biology or related discipline is required.

+ MS with min of 3 years, BS with a min of 5 years of relevant experience in GMP biopharmaceutical industry including Upstream Processing of Mammalian Cells is required

+ Knowledge of bioreactors design and control is required

+ Experience with cell culture single-use bioprocessing technologies is required

+ Strong leadership, organizational planning and project management skills, in addition to technical knowledge, is required to work with multi-disciplinary teams.

+ Must be self-motivated and work with minimum direction

+ Excellent interpersonal effectiveness and communication skills (written and oral) are required in order to interface across management levels and departments.

+ Ability to focus on specific production processes with great attention to details

+ Basic knowledge of Delta Vis a plus



**Preferred**



+ Knowledge of perfusion cell culture is a plus

+ Mammalian cell culture process development experience

+ Basic Delta V knowledge

+ Statistical tools for design of experiments



**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.



+ Last Date to Apply for Job: 11/21/2019

+ Eligible for Employee Referral Bonus



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

Categories

Posted: 2019-11-08 Expires: 2019-12-08

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Upstream Process Engineer, Gene Therapy Manufacturing Technical Services

Pfizer
Sanford, NC 27330

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