Gene Therapy Senior Operations Specialist
Posted on: January 15, 2019
ROLE RESPONSIBILITIES: The Senior Operations Specialist works as part of a team to execute batch activities in the state of the art gene therapy facility in Sanford, NC. The incumbent will be responsible for performing GMP activities in an assigned area, but is expected to have the flexibility to perform operations across all areas (cell culture, purification, solution prep, formulation/fill, pack/label) and all 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* Troubleshooting equipment and automation related issues on the floor The incumbent will have operations and technical expertise 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* 5 - 10 years experience in biotech operations with a minimum of a BS degree in any of the following preferred disciplines: Chemistry, Biochemistry, Biotechnology, Chemical Engineering, Chemistry, or equivalent science related or engineering discipline. 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'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 January, 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.
Keywords: Pfizer, Orlando , Gene Therapy Senior Operations Specialist, Healthcare , Sanford, Florida
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