Cell Culture - Senior Operations Specialist

Pfizer Sanford , FL 32771

Posted 2 weeks ago

ROLE SUMMARY

The 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 in bioreactor operations with 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

Additional expertise should include one or more of the following others areas:

  • Aseptic Processing

  • Downstream Purification Unit Operations

  • Formulation / Filling

  • Labeling / Packaging

  • Manufacturing and Quality Systems


  • 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

Execute clinical production on-time and without injury or defect. 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.

QUALIFICATIONS

A minimum of 5 years experience in biotech operations with a BS degree. Preferred disciplines include: Chemistry, Biochemistry, Biotechnology, Chemical Engineering, Chemistry, Microbiology or equivalent science related or engineering degree.

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: 11/29/2019
  • 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.

Manufacturing


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Cell Culture - Senior Operations Specialist

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