Gene Therapy Senior Operations Specialist

Employer
Pfizer
Location
Sanford, North Carolina, United States
Posted
Nov 16, 2020
Ref
4795811
Required Education
Bachelors Degree
Position Type
Full time
Why Patients Need You

Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer's mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.

What You Will Achieve

You will assess all existing and new processes and select or modify suitable equipment to ensure optimal manufacturing, safety and environmental performance of each process. You will be entrusted with assisting in the implementation and execution of all necessary validation requirements to ensure compliance with GMP (Good Manufacturing Practices) and safety standards. You will trouble shoot and review all processes and process equipment to ensure optimal performance of the equipment and the process.

As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.

It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It
  • Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
  • Author and approve quality and safety investigations and implementation of Corrective Action / Preventative Action.
  • Ensure that all documentation adheres to documentation model standard.
  • Own area change controls and commitments, identify potential process improvements projects.
  • Partner with Environment, Health & Safety (local applications) to build processes, tools, and mindsets that ensure a zero injury workplace.
  • Partner with the Quality, Technology and Operations personnel to investigate manufacturing incidents.
  • Lead and participate in investigations that address complex issues and assist with troubleshooting of processing difficulties.
  • Execute clinical production on-time and without injury or defects.
  • Develop, monitor and maintain asset care and standard work programs with OpEx.
  • Continually challenge technical solutions to ensure solutions are innovative and that they reflect industry best practice.
  • Manage accountability for protocol execution on the floor.
  • Provide direct feedback to colleagues about their performance.

Qualifications
Must-Have
  • Bachelor's Degree with 3- 5 years of experience in any of the following disciplines: Chemistry, Biochemistry, Biotechnology, Chemical Engineering, Chemistry, Microbiology or equivalent science related or engineering discipline.
  • Demonstrated experience working in cGMP (current Good Manufacturing Practices) {part of GxP} manufacturing environment is essential
  • Relevant experience relevant experience in Good Manufacturing Practices {also cGMP} biopharmaceutical industry including Upstream Processing of Mammalian Cells is required
  • Demonstrated change agility, team capability building, Training and Development experience
  • Excellent leadership, communication, and interpersonal skills
  • Self-motivated and demonstrated an ability to deliver results in a team environment


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.

It will be necessary to work 24/7 rotating or fixed 12 hour shifts according to operations schedules.

  • Last Date to Apply for Job: 11/30/2020

    Eligible for Relocation Package

    Eligible for Employee Referral Bonus


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.

Manufacturing