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Gene Therapy Mammalian Cell Culture Senior Operations Specialist

Company name
Pfizer Inc

Sanford, NC

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ROLE SUMMARY The Gene Therapy Mammalian Cell Culture Senior Operations Specialist works as part of a team to execute batch activities in a state of the art gene therapy manufacturing facility in Sanford, NC. The incumbent will have hands on experience and technical expertise with handling mammalian cell lines in bioreactors with a preference for experience in single-use technology. The incumbent will be responsible for performing GMP activities in any of the cell culture suites, but is expected to have the flexibility to perform operations across all areas (purification, solution prep, formulation\/fill, pack\/label) and all products. In addition to operating equipment the senior 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. Troubleshooting equipment and automation related issues on the floor. The incumbent will have operations and technical expertise in one or more of the following areas: Aseptic Processing Cell Culture \/ Viral Manufacturing Formulation \/ Filling Labeling \/ Packaging Manufacturing and Quality Systems Automation Manufacturing Technologies The Senior 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 while balancing primary responsibility of executing batch activities. The incumbent must also comply with applicable safety, occupational health, loss prevention and environmental requirements. ROLE RESPONSIBILITIES 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. QUALIFICATIONS A minimum of 2 - 4 years experience in Biotech Operations with an MS degree in the following preferred disciplines: Biology, Biochemistry, Biotechnology, Chemistry, Chemical Engineering,\u00a0Microbiology or equivalent science related or engineering degree. A minimum of 5-10 years experience in biotech operations with a BS degree in the above preferred disciplines. PHYSICAL\/MENTAL REQUIREMENTS 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. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS 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\u2019s 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: 26 March, 2018 Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Company info

Pfizer Inc
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Company Profile
Good health is vital to all of us, and finding sustainable solutions to the most pressing health care challenges of our world cannot wait. That's why we at Pfizer are committed to applying science and our global resources to improve health and well-being at every stage of life. We strive to provide access to safe, effective and affordable medicines and related health care services to the people who need them.

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