Pfizer Gene Therapy Mammalian Cell Culture Senior Operations Specialist in Sanford, North Carolina
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:
Cell Culture / Viral Manufacturing
Formulation / Filling
Labeling / Packaging
Manufacturing and Quality Systems
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.
Execute clinical production on-time and without injury or defects.
Develop Operations Specialists knowledge and skillset in areas of personal expertise.
Maintain inspection readiness of area.
Own area change controls and commitments.
Proactively implement improvements to business and manufacturing processes that improve flexibility, eliminate waste, and reduce variability.
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.
Implement 5S, standard work, visual management, special cause and common cause problem solving in area.
Role model OWNIT! behaviors.
Partner with EHS to build processes, tools, and mindsets that ensure a zero injury workplace.
Author and approve quality and safety investigations and implementation of CAPA.
Execute a robust operator care program.
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, Microbiology 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.
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.
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- 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.