Gene Therapy Operations Specialist 1

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 be responsible for planning and coordinating various manufacturing activities with process engineers, supervisors and managers involving multiple site manufacturing departments.  You will be managing manufacturing cGMP documentation system, planning and scheduling batch/buffer activities to support multiple clinical/commercial manufacturing operations.

You will be proficient in maintaining manufacturing inventory for consumable items and manage duties in multiple vaccine programs/departments in a manner consistent with site and corporate cGMP, safety, environmental and human resources policies, procedures and compliance initiatives. As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.

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

How You Will Achieve It

The Gene Therapy Operations Specialist works as part of a team to execute batch activities in a new state of the art gene therapy manufacturing facility in Sanford, NC.  The incumbent is will be responsible for performing GMP activities in an assigned area, but is expected to begin learning operations across multiple areas (cell culture, purification, solution prep, formulation/fill, pack/label) and 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

• Participating in investigations

• In addition, the operations specialist may be assigned as a team member on cross functional teams and be given project assignment to develop problem solving, technical expertise, and leadership capability.

  The incumbent must also comply with applicable safety, occupational health, loss prevention and environmental requirements.

• Execute batch activities on-time and without injury or defect.

• Monitor the status of training and complete all required training prior to performing associated tasks.

• Update and maintain information in manufacturing support systems used for planning, variance tracking, and continuous improvement.

• Proactively implement improvements to business and manufacturing processes that improve flexibility, eliminate waste, and reduce variability.

• Maintain the accuracy of all documentation needed for operations including SOPs, batch records and compounding records.

• Execute and sustain the components of the lean management system such as 5S, standard work, and visual management.

• Role model OWNIT! behaviors.

• Perform pre-task safety checks and demonstrate commitment to developing and maintain a safe workplace.

• Execute assigned activities associated with the operator care program.

QualificationsMust-Have

• BS degree in any of the following disciplines:  Chemistry, Biochemistry, Biotechnology, Chemical Engineering, Microbiology or equivalent science related or engineering discipline and 0–2 years experience in manufacturing in pharmaceutical industry

• 2 year' Associates degree in a science-related discipline and  2–4 years' experience in manufacturing in pharmaceutical industry

  
 

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

• Night Shift 24/7 (12 hours) rotating or fixed shifts with overtime.

Other job details

• Last day to apply: 3/9/2022

• Employee Referral Bonus eligible

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment.  As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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