Job was saved successfully.
Job was removed from Saved Jobs.

Job Details


Pfizer: One of the World's Premier Biopharmaceutical Companies

Gene Therapy Senior Operations Specialist

Pharmaceuticals

All

Full Time

On Site

No

Greenville, North Carolina, United States

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 work as part of a team to execute batch activities in a state of the art gene therapy manufacturing facility. You will be responsible for performing GMP activities in an assigned area and begin learning operations across multiple areas (cell culture, purification, solution prep, formulation/fill, pack/label) and products while complying with applicable safety, occupational health, loss prevention and environmental requirements.

As a Team lead, you will be involved in leading work teams within a division. You will lead the people, technical and financial resources of the team. Thanks to your technical skills, you will coach your direct reports on day to day activities. You will be relied on to solve complex problems within your area of expertise.

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

Role Summary

The Gene Therapy 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 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 in 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 defect.

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 adheres 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.

QualificationsMust-Have
  • Bachelor's Degree (Chemistry, Biochemistry, Chemical Engineering, Microbiology or equivalent related or engineering discipline)
  • 3+ years’ experience
  • Demonstrated experience in a pharmaceutical or manufacturing setting
  • Able to read and write, as well as, follow written and oral instructions
Nice-to-Have
  • Master's degree
  • Strong background in Good Manufacturing Practices {also see cGMP} compliance and working knowledge of System Application and Products


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

24/7 (12 hour) rotating or fixed shifts with overtime.

Relocation support available

Relocation support available

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

#LI-PFE